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Histologic documentation: pathologic confirmation of invasive breast cancer by core or surgical biopsy (fine-needle aspiration [FNA] alone is not adequate)Xx_NEWLINE_xXIpsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS) or breast-conserving treatment and hormonal therapy for DCIS or invasive cancerXx_NEWLINE_xXOperable invasive breast cancerXx_NEWLINE_xXInvasive lobular cancerXx_NEWLINE_xXNew diagnosis of DCIS without invasive cancer; date of diagnosis defined as the date of the first pathology report that diagnosed the patient with DCISXx_NEWLINE_xXNo previous history of breast cancer (DCIS or invasive cancer) in either breast prior to current DCIS diagnosisXx_NEWLINE_xXSubjects must have histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer\r\n* A core biopsy interpreted as invasive cancer meets this criterion; if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy)\r\n* Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; eligibility for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery; if patient is eligible based on either, they are eligible for the study\r\n* Bilateral breast carcinoma is allowed provided either:\r\n** Diagnoses are synchronous – that is, within 3 months of one another – and at least one of the two breast carcinomas meet the eligibility criteria and neither is Her-2 positive or inflammatory; OR\r\n** The contralateral breast cancer was at least 5 years prior to the current diagnosis\r\n* No evidence of metastatic diseaseXx_NEWLINE_xXNo history of invasive breast cancer in 5 years prior to study registration other than the current diagnosis (prior ductal breast carcinoma in situ [DCIS] at any time is acceptable)Xx_NEWLINE_xXSurgical margins must be clear of invasive carcinoma; if there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended; if further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumor bed is delivered; in situ lobular disease at the margin is acceptableXx_NEWLINE_xXThe tumor must be unilateral invasive adenocarcinoma of the breast on histologic examinationXx_NEWLINE_xXSynchronous or previous contralateral invasive breast cancer; (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)Xx_NEWLINE_xXAny previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible)Xx_NEWLINE_xXNo prior history of ipsilateral breast cancer (invasive disease or ductal carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowedXx_NEWLINE_xXNo history of prior or concurrent contralateral invasive breast cancer; benign breast disease; LCIS or DCIS of contralateral breast is allowedXx_NEWLINE_xXFor those patients who also undergo contralateral breast surgery, if invasive disease is found in the contralateral breast, the patient is not eligible for registration /randomizationXx_NEWLINE_xXPost neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery; residual cancer is defined as a contiguous focus of residual invasive cancer, in the breast, measuring >= 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination; please note that in patients that have multifocal or multicentric residual tumors these lesions cannot be added up; the biggest lesion has to measure >= 1 cm in diameter; this is required due to constraints in deoxyribonucleic acid (DNA) extraction for PAM50 analysis\r\n* NOTE: The presence of ductal carcinoma in situ (DCIS) without invasion does not qualify as residual invasive disease in the breast\r\n* NOTE: Despite lymph node involvement if residual invasive cancer in the breast is < 1 cm in diameter patients are not eligible for participationXx_NEWLINE_xXNo history of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sortXx_NEWLINE_xXPathologic confirmation of invasive breast cancer diagnosed by core needle biopsyXx_NEWLINE_xXDocumentation of mammogram and ultrasound (including ductal carcinoma in situ [DCIS] and invasive cancer) of the diseased breast performed within 56 days prior to registration; mammogram for the unaffected contralateral breast is required within 12 months prior to registrationXx_NEWLINE_xXHistory of invasive breast cancer or contralateral DCISXx_NEWLINE_xXNo invasive cancer at the surgical marginsXx_NEWLINE_xXSynchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible)Xx_NEWLINE_xXAny prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous or previous ipsilateral LCIS are eligible)Xx_NEWLINE_xXCompleted adequate breast surgery defined as:\r\n* The inked margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ with the exception of the posterior margin if this margin is the pectoralis major fascia or the anterior margin if this is the dermis; patients with resection margins positive for lobular carcinoma in situ are eligible\r\n* Patients with breast conservation must have adjuvant radiotherapy; patients having mastectomy may have adjuvant radiotherapy according to local policy and/or international guidelinesXx_NEWLINE_xXPathologically (histologically or cytologically) proven diagnosis of invasive breast cancerXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer, curatively resected thyroid papillary carcinoma, and invasive and non-invasive cancers related to the breast cancer) unless disease free for a minimum of 3 yearsXx_NEWLINE_xXPatients with multicentric and/or multifocal and/or bilateral early invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER+ and/or PR+ and HER2-.Xx_NEWLINE_xXHistologic documentation of invasive adenocarcinoma of the breastXx_NEWLINE_xXAny history, not including the index cancer, of ipsilateral or contralateral invasive breast cancer or ipsilateral or contralateral DCIS treated with radiation therapy (RT)\r\n* Note: Patients with synchronous or previous ipsilateral LCIS are eligibleXx_NEWLINE_xXCuratively treated ductal or lobular breast carcinoma in situ and not currently receiving any systemic therapyXx_NEWLINE_xXDCIS or Stage I-III primary invasive carcinoma of the breastXx_NEWLINE_xXHistologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtypeXx_NEWLINE_xXEvidence of muscle-invasive or regional and/or distant metastatic bladder cancer, or high grade urothelial carcinoma in the prostate or upper urinary tractXx_NEWLINE_xXCuratively treated ductal carcinoma in situ of the breast.Xx_NEWLINE_xXParticipants must have histologically confirmed invasive breast cancer; all histologic subtypes are eligibleXx_NEWLINE_xXAll patients must be diagnosed with invasive breast cancerXx_NEWLINE_xXPatients with known bilateral invasive breast cancer; patients with contralateral in situ breast carcinoma are eligibleXx_NEWLINE_xXHistologically confirmed invasive lobular breast cancer, that is hormone receptor-positive and HER2-negative, measuring at least 1 centimeter (cm) radiographically or clinically, clinical stages I-III; invasive lobular histology will be diagnosed at the enrolling institution for purposes of study participation; subsequently, invasive lobular histology will be confirmed by central pathology review, but this central review will not be required prior to patient enrollmentXx_NEWLINE_xXDiagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:Xx_NEWLINE_xXPrior breast cancer or other invasive malignancy treated within 5 yearsXx_NEWLINE_xXClinical T2-T4c, any N, M0 invasive ER+ (Allred score of 6-8) and HER2 negative (0 or 1+ by immunohistochemistry [IHC] or fluorescent in situ hybridization [FISH] negative for amplification) breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node\r\n* Note: patients with invasive ER+ (Allred Score of 6-8) HER2- breast cancer or ductal carcinoma in situ (DCIS) in the contralateral breast the patient are eligibleXx_NEWLINE_xXPIK3CA WILD TYPE COHORT (closed 03/17/2016): Clinical T2-T4c, any N, M0 invasive ER+ (Allred score of 6-8) and HER2 negative (0 or 1+ by IHC or FISH negative for amplification) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node\r\n* Note: patients with invasive ER+ (Allred score of 6-8) HER2- breast cancer or DCIS in the contralateral breast the patient are eligibleXx_NEWLINE_xXPrimary operable, non-metastatic invasive carcinoma of the breast, confirmed histologically by core biopsy.Xx_NEWLINE_xXPrior chemotherapy or radiation therapy for invasive breast cancer within 6 months before registrationXx_NEWLINE_xXThe diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.Xx_NEWLINE_xXPrevious history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)Xx_NEWLINE_xXPrevious history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)Xx_NEWLINE_xXPrior history of invasive breast cancerXx_NEWLINE_xXHistory of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy >5 years prior to diagnosis of current breast cancerXx_NEWLINE_xXHistory of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed >5 years prior to diagnosis of current breast cancerXx_NEWLINE_xXDiagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy with any type of axillary surgery or axillary samplingXx_NEWLINE_xXInvasive features on colposcopy and the biopsy specimenXx_NEWLINE_xXAdequately treated breast ductal carcinoma in situXx_NEWLINE_xXHigh grade and/or invasive and/or carcinoma in situ diseaseXx_NEWLINE_xXPatients with sessile appearing tumors, which may be invasive or high-gradeXx_NEWLINE_xXMust have pathology proven breast cancer. Pathology must be invasive ductal or lobularXx_NEWLINE_xXPatients with concurrent upper urinary tract (i.e. ureter, renal pelvis) non-invasive urothelial carcinomaXx_NEWLINE_xXPrior breast cancer or other invasive malignancy treated within 5 yearsXx_NEWLINE_xXDiagnosis of muscle-invasive bladder cancerXx_NEWLINE_xXBreast cancer\r\n* Infiltrating ductal carcinoma or ductal carcinoma in situ (DCIS), stage T0, T1, and T2 =< 3.0 cm, N0 and M0\r\n* Patients benefiting from high dose rate brachytherapy (HDR) as either as a boost or accelerated partial breast irradiation regimenXx_NEWLINE_xXINCLUSION - ENROLLMENT: Diagnosis of invasive ductal carcinomaXx_NEWLINE_xXHistologic confirmation of invasive breast cancer with any measures of ER, PR and HER2neuXx_NEWLINE_xXFor part B and part C, Presence of other active invasive cancers other than NSCLC or history of treatment for invasive cancer other than NSCLC in the past 3 years. Exceptions are:Xx_NEWLINE_xXHistological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the bladder.Xx_NEWLINE_xXCOHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients with a history of another invasive malignancy within the last 3 yearsXx_NEWLINE_xXCOHORT 2: TRIPLE NEGATIVE BREAST CANCER: Patients with a history of another invasive malignancy within the last 3 yearsXx_NEWLINE_xXNaive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.Xx_NEWLINE_xXPatient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.Xx_NEWLINE_xXInvasive cancer in the contralateral breastXx_NEWLINE_xXHistologically confirmed invasive cancer of the breastXx_NEWLINE_xXOther invasive cancers diagnosed < 3 years back that required systemic treatment; if diagnosed with other invasive cancer >= 3 years, should have complete recovery from all systemic toxicity except neuropathy and alopeciaXx_NEWLINE_xXHistologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breastXx_NEWLINE_xXHistologically confirmed invasive carcinoma or ductal carcinoma in situ (DCIS) of the breastXx_NEWLINE_xXPrior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowedXx_NEWLINE_xXHistory of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowedXx_NEWLINE_xXMultifocal breast cancer, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5 cm, or within the same breast quadrantXx_NEWLINE_xXHave had or are planning to have the following invasive procedures:Xx_NEWLINE_xXHistologic or clinical evidence of invasive breast cancerXx_NEWLINE_xXHistologically confirmed diagnosis of invasive breast cancerXx_NEWLINE_xXInvasive cancer in the contralateral breastXx_NEWLINE_xXPatients with any active invasive cancer are not eligibleXx_NEWLINE_xXHistologically confirmed ductal carcinoma in situ (DCIS) or invasive breast cancer (stages I, II, or III) with primary tumor(s) >= 1.0 cm on mammogram, ultrasound, magnetic resonance imaging (MRI), or physical exam or histologically confirmed adenocarcinoma of the colon, stages I, II or III with primary tumor >= 1cm visualized by colonoscopyXx_NEWLINE_xXSubjects must not have invasive lobular carcinomaXx_NEWLINE_xXNo prior systemic therapy or radiotherapy for currently-diagnosed invasive or noninvasive breast cancerXx_NEWLINE_xXPrior systemic therapy for invasive or non-invasive (DCIS) breast cancerXx_NEWLINE_xXBilateral invasive breast cancerXx_NEWLINE_xXPatients with high risk muscle invasive urothelial carcinoma (hydronephrosis, palpable mass on examination under anesthesia, muscle invasive urothelial carcinoma with lymphovascular invasion on pathologic specimen, > T3 disease) or those with lymph node positive or metastatic disease are to be excludedXx_NEWLINE_xXHistologically-confirmed, primary, invasive breast cancer diagnosed within 5 years of study entryXx_NEWLINE_xXPatients must have stage I to III histologically confirmed invasive carcinoma of the breast; a minimum tumor size of at least 1.5 cm determined by physical exam or imaging (whichever is larger) is requiredXx_NEWLINE_xXFor the window phase: Patients must have histologically confirmed invasive lobular carcinoma or invasive ductal carcinoma; no central confirmation of histological subtype is necessary for enrollment; patients with mixed invasive ductal and lobular carcinoma are eligible and will be stratified as ductalXx_NEWLINE_xXPatients with a history of ipsilateral or contralateral ductal carcinoma in situ (DCIS) are eligibleXx_NEWLINE_xXHistologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality.Xx_NEWLINE_xXBilateral invasive BC.Xx_NEWLINE_xXInvasive adenocarcinoma of the breast diagnosed by core needle biopsyXx_NEWLINE_xXHistory of ipsilateral invasive breast cancer or ipsilateral ductal carcinoma in situ (DCIS); Note: patients with history of ipsilateral lobular carcinoma in situ (LCIS) are eligibleXx_NEWLINE_xXPrior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breastXx_NEWLINE_xXEstrogen receptor negative invasive breast carcinoma as defined as less than 10% stained cellsXx_NEWLINE_xXPrior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)Xx_NEWLINE_xXDuctal breast carcinoma in situ (DCIS) onlyXx_NEWLINE_xXAny prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breastXx_NEWLINE_xXMuscle invasive (T2 or above) urothelial carcinoma or urothelial carcinoma outside the bladderXx_NEWLINE_xXPatients must have histologically confirmed invasive breast cancer (stages I-III) who have undergone core needle biopsy (clinically or radiographically at least T1c to allow adequate residual cancer tissue at surgery) and will be scheduled for surgical resection (i.e. segmental excision or mastectomy)Xx_NEWLINE_xXHas invasive breast cancer; this does not include microinvasionXx_NEWLINE_xXPatients with concurrent upper urinary tract (i.e. ureter, renal pelvis) invasive urothelial carcinoma; (NOTE: Patients with history of non-invasive [Ta, Tis] upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment [i.e. cytology, biopsy, imaging] that demonstrates no evidence of residual disease are eligible)Xx_NEWLINE_xXNo prior history of an invasive breast cancerXx_NEWLINE_xXCohort A – T2, Transitional cell carcinoma (TCC) muscle invasive bladder cancer, (patients who are cisplatin ineligible, decline neoadjuvant and/or ineligible for neoadjuvant chemotherapy); must have histological proof of T2, muscle-invasive transitional cell carcinoma of the bladder with no evidence of metastatic; patient with any degree of fixation of the pelvic sidewall are not eligibleXx_NEWLINE_xXPathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancerXx_NEWLINE_xXHave muscle-invasive (>= T2) bladder cancerXx_NEWLINE_xXPatients with histologically confirmed intact primary cancer that is confirmed invasive carcinoma of the breast, with at least 1.0 cm residual disease as measured by mammography, ultrasound, or breast magnetic resonance imaging (MRI) after neoadjuvant anthracycline based chemotherapyXx_NEWLINE_xXDuctal carcinoma in situ (DCIS) or invasive epithelial (ductal, medullary, papillary, mucinous [colloid], or tubular histologies)Xx_NEWLINE_xXPatients with a history of non-breast invasive malignancies are eligible if they have been disease-free for 1 or more years prior to entry into the studyXx_NEWLINE_xXMulticentric gross breast carcinoma (either DCIS or invasive cancer) or microscopic breast carcinoma occupying a volume with maximum dimensions of more than 3 centimetersXx_NEWLINE_xXSynchronous bilateral invasive or non-invasive breast cancerXx_NEWLINE_xXRecurrent high-risk non-muscle-invasive bladder cancer after prior intravesical BCG therapy meeting all of the following criteria: \r\n* Histologically documented diagnosis of urothelial carcinoma confirmed by the Department of Pathology at Memorial Sloan Kettering Cancer Center (MSKCC)\r\n* Documentation of activating FGFR3 mutation or gene fusion on an assay performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\r\n* History of high-grade non-muscle-invasive bladder cancer (NMIBC)\r\n* Clinical evidence of high-grade, stage pTa NMIBC\r\n* Prior intravesical therapy with at least one induction course of BCG\r\n* Multiple papillary lesions with at least one amenable to marker tumor study (=< 1 cm, non-invasive; or could be partially resected to leave a non-invasive lesion =< 1 cm) OR solitary papillary lesion amenable to marker tumor study (=< 1 cm, non-invasive)Xx_NEWLINE_xXOther active invasive malignancy. History of non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast is allowed, as is history of other invasive malignancy that is in remission after treatment with curative intentXx_NEWLINE_xXScheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS within 1 monthXx_NEWLINE_xXPathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomyXx_NEWLINE_xXConfirmed diagnosis of invasive BCCXx_NEWLINE_xXWomen with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast; biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosisXx_NEWLINE_xXWomen with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast\r\n* Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosisXx_NEWLINE_xXClinical T1N0M0 invasive carcinoma or ductal carcinoma in situ (DCIS) < or equal to 2 cmXx_NEWLINE_xXHistologically confirmed diagnosis of invasive breast cancerXx_NEWLINE_xXClinical stage T2-T4c, any N, M0 primary tumor by American Joint Committee on Cancer (AJCC) 7th edition clinical staging prior to neoadjuvant chemotherapy, with residual invasive breast cancer after neoadjuvant therapy; if the patient has invasive cancer in the contralateral breast, she is not eligible for this studyXx_NEWLINE_xXInvasive cancer in the contralateral breastXx_NEWLINE_xXHave suspected or known invasive (>= T1) bladder cancerXx_NEWLINE_xXHave non-invasive (< T1) bladder cancerXx_NEWLINE_xXPreviously untreated breast cancer determined by a core needle biopsy showing invasive ductal carcinoma or invasive lobular carcinomaXx_NEWLINE_xXHistologically confirmed diagnosis of invasive breast cancerXx_NEWLINE_xXClinical stage T1c-T4c, any N, M0 primary tumor by American Joint Committee on Cancer (AJCC) 7th edition clinical staging prior to neoadjuvant chemotherapy, with residual invasive breast cancer after neoadjuvant therapy; if the patient has invasive cancer in the contralateral breast, she is not eligible for this studyXx_NEWLINE_xXInvasive cancer in the contralateral breastXx_NEWLINE_xXOther invasive malignancies within past 5 years from date of registrationXx_NEWLINE_xXPatients must have histologic or cytologic confirmation of the diagnosis of invasive adenocarcinoma of the breast.Xx_NEWLINE_xXAny suspicion for invasive cancerXx_NEWLINE_xXNewly diagnosed histologically confirmed invasive breast cancerXx_NEWLINE_xXProven multicentric carcinoma (invasive or ductal carcinoma in situ [DCIS]) in more than one quadrant or separated by > 4 centimetersXx_NEWLINE_xXOther invasive malignancies within the past 5 years from date of registrationXx_NEWLINE_xXUnifocal primary invasive breast carcinoma diagnosed by core needle biopsyXx_NEWLINE_xXMultifocal or multicentric invasive breast carcinomaXx_NEWLINE_xXSubjects with histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy with a plan of surgical excision (goal: approximately 2 weeks of study medications after enrollment)Xx_NEWLINE_xXPatients with known (biopsy proven) invasive carcinoma in a potential study polypXx_NEWLINE_xXNewly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])Xx_NEWLINE_xXHistologically confirmed diagnosis of invasive or non-invasive breast cancerXx_NEWLINE_xXGross disease must be unifocal with pathologic (invasive and/or ductal carcinoma in situ [DCIS]) tumor size 3 cm or less; (patients with microscopic multifocality are eligible as long as total pathological size is 3 cm or less)Xx_NEWLINE_xXBreast cancers with an extensive in-situ ductal component (defined as >= 25% of the tumor volume and DCIS present within and in the surrounding normal breast tissue of the invasive tumor)Xx_NEWLINE_xXProven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or two or more breast cancers not resectable through a single lumpectomy incisionXx_NEWLINE_xXMust have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS).Xx_NEWLINE_xXFor tumors that are invasive, if in the presence of extensive intraductal component (EIC), the entire pathologic tumor size (including both the intraductal and invasive component) must be 3.0 cm or less.Xx_NEWLINE_xXPrevious history of ipsilateral invasive breast cancer or DCIS.Xx_NEWLINE_xXHistologic examination showing invasive lobular histology.Xx_NEWLINE_xXHistologically-proven, invasive primary carcinoma of the cervixXx_NEWLINE_xXBiopsy-proven, unresected stage IB-IVA invasive carcinoma of the cervixXx_NEWLINE_xXOn histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breastXx_NEWLINE_xXProven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimetersXx_NEWLINE_xXSynchronous bilateral invasive or non-invasive breast cancerXx_NEWLINE_xXNo prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast; patients with a local recurrence of a previously excised phyllodes tumor are eligible if the recurrence is in the area of the previous excisionXx_NEWLINE_xXBreast carcinoma or ductal carcinoma in situ in the ipsilateral breastXx_NEWLINE_xXDuctal carcinoma in-situ or invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies; invasive lobular carcinomas are allowedXx_NEWLINE_xXAmerican Joint Committee on Cancer (AJCC) stage 0-IIIa (pathologic stage Tis, T1N0, T2N0, T1N1a, T2N1a, T1N2a, T2N2a, M0) histologically confirmed ductal carcinoma in-situ or invasive carcinoma of the breast with a lesion =< 5 cm treated with lumpectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)Xx_NEWLINE_xXPatients with lobular carcinoma in-situ alone (no invasive component) and patients with non-epithelial breast malignancies such as sarcoma or lymphomaXx_NEWLINE_xXHave had or are planning to have the following invasive procedures:Xx_NEWLINE_xXHistologically confirmed invasive primary breast cancerXx_NEWLINE_xXWomen referred for breast conservation surgery following a diagnosis of invasive or in situ carcinoma of the breast by histopathology or women referred for lumpectomy due to a benign (fibroadenoma or papilloma) or high risk breast lesion(Atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in-situ, atypical papilloma).Xx_NEWLINE_xXCurrent diagnosis of invasive or inflammatory breast carcinomaXx_NEWLINE_xXAtypical endometrial or glandular cells or evidence of invasive cervical carcinoma on cervical biopsy;Xx_NEWLINE_xXHistologically confirmed invasive triple negative Breast CancerXx_NEWLINE_xXWomen scheduled for unilateral or bilateral mastectomy for breast cancer therapy, pathology confirmed stage 0-III (including ductal carcinoma in situ), or prophylaxis (BRCA1/2 mutation carriers, women with strong family history or lobular carcinoma in situ or other conditions where prophylactic mastectomy has been elected)Xx_NEWLINE_xXPrior history of invasive breast cancer or ductal breast carcinoma in situ (DCIS)Xx_NEWLINE_xXBiopsy confirmed multifocal, multicentric, or contralateral disease that is invasive or non-invasiveXx_NEWLINE_xXPresence of other active invasive cancers.Xx_NEWLINE_xXHistologic or cytologic confirmation of invasive breast cancer that is HER2-negative by standard clinical criteriaXx_NEWLINE_xXOther active invasive malignancy; history of non-invasive malignancies such as ductal carcinoma in situ of the breast, non-melanomatous carcinoma of the skin, is allowed, as is history of other invasive malignancy that is in remission for >/= 5 years after treatment with curative intentXx_NEWLINE_xXNon-muscle invasive, localized bladder cancer (Tis, Ta, T1)Xx_NEWLINE_xXPreviously untreated breast cancer determined by a core needle biopsy showing invasive ductal carcinoma or invasive lobular carcinomaXx_NEWLINE_xXHistologic confirmation of invasive adenocarcinoma originating in the breastXx_NEWLINE_xXParticipants must have histologically confirmed invasive breast cancer; all histologic subtypes are eligibleXx_NEWLINE_xXHistologically confirmed invasive breast cancerXx_NEWLINE_xXMulticentric invasive or in situ carcinomaXx_NEWLINE_xXMust have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvisXx_NEWLINE_xXStudy participants must be cT1c - cT4a-d any N, M0; any T is allowed if node positive (biopsy proven and HER2 positive) including no primary invasive cancer or only ductal breast carcinoma in situ (DCIS); metastatic workup is not requiredXx_NEWLINE_xXFemale patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e., index cancer)Xx_NEWLINE_xXPatients with core breast biopsy that, on pathology review, demonstrates invasive breast cancer and are determined to need surgical excision of the lesion; all subtypes of invasive breast cancer will be enrolled; core biopsy specimens of enrolled patients will be stained for RET by immunohistochemistry and scored, however, patients will not be excluded according to RET expressionXx_NEWLINE_xXPathologic documentation of invasive breast cancer by biopsy (fine needle aspiration [FNA] alone is not adequate)Xx_NEWLINE_xXIpsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS) or breast conserving treatment and hormonal therapy for DCIS or invasive breast cancerXx_NEWLINE_xXOther invasive cancers that are clinically activeXx_NEWLINE_xXOn histologic examination, the tumor must be ductal carcinoma in situ (DCIS) and/or invasive breast carcinomaXx_NEWLINE_xXPrior history of DCIS or invasive breast cancerXx_NEWLINE_xXMulticentric carcinoma (DCIS or invasive)Xx_NEWLINE_xXSynchronous bilateral invasive or non-invasive breast cancerXx_NEWLINE_xXThe diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsyXx_NEWLINE_xXSynchronous bilateral invasive breast cancerXx_NEWLINE_xXSynchronous or previous contralateral invasive breast cancer; (patients with synchronous and/or previous contralateral ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] are eligible)Xx_NEWLINE_xXAny previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible)Xx_NEWLINE_xXPathologic confirmation of DCIS of the female breast without invasive cancer, with diagnosis rendered on core biopsy only, completed within 60 days before registration; patients diagnosed with DCIS on the basis of surgical biopsy are not eligible for this study\r\n* Patients with microinvasion on diagnostic core biopsy, defined as tumor =< 1mm in greatest dimension, will be allowed to participate\r\n* All patients must have a clip placed, either at the time of the diagnostic biopsy or at the time of the baseline MRI prior to the start of treatmentXx_NEWLINE_xXPatients have histological confirmation of invasive breast carcinomaXx_NEWLINE_xXThe participant has breast biopsy consistent with ductal carcinoma in situ (DCIS)Xx_NEWLINE_xXKnown invasive breast cancer of any typeXx_NEWLINE_xXBiopsy-proven invasive breast cancer, excised with negative margins of at least 1 mmXx_NEWLINE_xXPatients with multifocal, multicentric and synchronous bilateral breast cancers are allowed\r\n* Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant; (NOTE: the Oncotype DX testing must be completed on the largest lesion)\r\n* Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants (NOTE: Oncotype DX testing should be completed on all tumors and the determination for eligibility should be made on the highest recurrence score)\r\n* Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other; (NOTE: the Oncotype DX testing should be completed on both tumors and the tumor with the highest recurrence score should be used)Xx_NEWLINE_xXPatients with a prior diagnosis of contralateral ductal carcinoma in situ (DCIS) are eligible if they underwent a mastectomy or lumpectomy with whole breast radiation; prior partial breast irradiation, including brachytherapy, is not allowed; patients with a prior diagnosis of ipsilateral DCIS or invasive breast cancer who received radiation to that breast are not eligibleXx_NEWLINE_xXPatients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation); patients must have clear margins from both invasive breast cancer and DCIS (as per local institutional guidelines); lobular carcinoma in situ (LCIS) at the margins is allowedXx_NEWLINE_xXPatient has been diagnosed and/or treated for any invasive cancer (other than study disease) less than 5 years prior to study enrollment.Xx_NEWLINE_xXHistologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder as follows:Xx_NEWLINE_xXPatients must have HER2-positive stage II or III histologically confirmed invasive carcinoma of the breast; a minimum tumor size of 2 cm determined by physical exam or imaging (whichever is larger) is requiredXx_NEWLINE_xXHistory of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrenceXx_NEWLINE_xXPatients with the following tumors are included in the study:\r\n* Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, Federation of Obstetricians and Gynecologists [FIGO], World Health Organization [WHO] or Silverberg)\r\n* Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg)Xx_NEWLINE_xXHistologically confirmed unilateral or bilateral primary invasive carcinoma of the breast.Xx_NEWLINE_xXResidual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion.Xx_NEWLINE_xXNote that patients with (i) non-invasive breast cancer (DCIS) alone, (ii) incidental (microscopic) nodal cancer without a primary tumor (pN1mi), or (iii) metastatic disease are excluded.Xx_NEWLINE_xXHistory of another invasive cancer within 3 years of randomization;Xx_NEWLINE_xXThe subject with a previous history of a non-invasive carcinoma is eligible if he/she has had successful curative treatment any time prior to Screening.Xx_NEWLINE_xXHistologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.Xx_NEWLINE_xXUnresectable HCC confirmed by histology or by non-invasive AASLD criteriaXx_NEWLINE_xXConfirmed histologic diagnosis of invasive adenocarcinoma of the breast, including Memorial Sloan-Kettering Cancer Center (MSKCC) pathology confirmationXx_NEWLINE_xXPatients must have pathologically confirmed non-muscle invasive bladder cancer (NMIBC) high grade disease (HG), as defined by the 2004 WHO classification systemXx_NEWLINE_xXPatients must have no evidence of muscle invasive diseaseXx_NEWLINE_xXSubjects with ductal carcinoma in situ (DCIS) that express HER-2 on 10% of the DCIS that have not had definitive surgery are diagnosed by core biopsy or needle-localized (NL) surgical biopsy with positive marginsXx_NEWLINE_xXBiopsy-proven invasive breast cancer, excised with negative margins of at least 1 mmXx_NEWLINE_xXHistologically confirmed invasive breast cancer with a primary tumor size of greater than (>) 2 cmXx_NEWLINE_xXParticipants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancerXx_NEWLINE_xXPathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancerXx_NEWLINE_xXNo prior history of non-breast invasive malignancies in the past 1 yearXx_NEWLINE_xXPrior invasive non-breast malignancy unless disease free for a minimum of 1 year prior to registrationXx_NEWLINE_xXNon-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excisedXx_NEWLINE_xXHistory of any prior (ipsi- and/or contralateral) invasive breast cancerXx_NEWLINE_xXAlternatively, if Miller-Payne or RCB grading is not available, the patient will be eligible if the pathology report indicates that the area of residual invasive disease in the breast measures at least 2 cm following preoperative therapy. The presence of DCIS without invasion does not qualify as residual disease in the breast.Xx_NEWLINE_xXPathologically confirmed invasive breast cancer by core needle biopsyXx_NEWLINE_xXClinical T2-T4c, any N, M0 invasive breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node;\r\n* The extent of disease is a solitary lesion where the lesion: \r\n** is palpable\r\n** size can be measured bi-dimensionally by tape, ruler or caliper technique, and\r\n** largest tumor diameter is at least 2.0 cm (that is considered measurable by the World Health Organization[WHO] criteria)\r\n* Note:\r\n** Patients with contralateral invasive breast cancer are not eligible\r\n** Patients with contralateral ductal carcinoma in situ (DCIS) are eligible\r\n** Patients with multifocal/multi-centric invasive breast cancer are not eligible; additional foci of DCIS in the same breast are acceptableXx_NEWLINE_xXHistory of invasive breast cancer prior to the current diagnosisXx_NEWLINE_xXPatients must have histologically confirmed invasive breast cancer with a primary tumor >= 2 cm in greatest dimension as measured by clinical or radiologic examinationXx_NEWLINE_xXHistologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situXx_NEWLINE_xXGrade 1-3 invasive ductal, mammary, mucinous, tubular, colloidal, or pure ductal carcinoma in situ (DCIS) measuring =< 2.5 cm on final pathology (the tumor should be clinical stage T1N0M0 in patients electing brachytherapy in whom the catheter will be placed intraoperatively)Xx_NEWLINE_xXProven multicentric carcinoma (DCIS or invasive) in more than one quadrant or separated by 4 or more centimeters or diffuse (> 1 quadrant) suspicious calcificationsXx_NEWLINE_xXHistory of previous invasive breast cancer =< 5 years\r\n* NOTE: history of DCIS, lobular carcinoma in situ (LCIS) is allowedXx_NEWLINE_xXHistory of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiotherapy or contralateral invasive breast cancer at any time.Xx_NEWLINE_xXPatients with multifocal, multicentric and synchronous bilateral breast cancers are allowed:\r\n* Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant\r\n* Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants\r\n* Synchronous bilateral disease is defined as invasive breast cancer in both breasts, diagnosed within 30 days of each otherXx_NEWLINE_xXPatients with a hormone receptor-positive, HER2-negative invasive cancer that meets study criteria may have ductal carcinoma in situ in another quadrant of the same breast or in the contralateral breast even if the DCIS is hormone receptor-negativeXx_NEWLINE_xXParticipants with a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are not allowed to enter the study if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast (they are allowed to enter the study if treated with surgery alone)Xx_NEWLINE_xXPHASE II: Participants must have histologically confirmed invasive breast cancer; all histologic subtypes are eligibleXx_NEWLINE_xXNon-metastatic histologically confirmed primary invasive breast carcinoma that was operableXx_NEWLINE_xXHistory of any prior (ipsilateral and/or contralateral) invasive breast carcinomaXx_NEWLINE_xXHistory of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the studyXx_NEWLINE_xXMust have completed definitive resection of primary tumor. The most recent surgery for breast cancer must have been completed at least 14 days prior (but no more than 84 days prior) to study registration. NOTE: Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however participants with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy. Participants with margins positive for lobular carcinoma in situ (LCIS) are eligible. Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable.Xx_NEWLINE_xXResidual invasive disease in the breast measuring at least 2 cm. The presence of DCIS without invasion does not qualify as residual disease in the breast.Xx_NEWLINE_xXUndergoing laparoscopic or minimally invasive surgeryXx_NEWLINE_xXHistologically-confirmed ductal carcinoma in situ (DCIS) or stage I-III invasive carcinoma of the breast; NOTE: women with history of breast cancer, radiation, or plastic surgery to the contralateral breast, or concurrent bilateral breast cancer, will not participate in the FNA portion of the studyXx_NEWLINE_xXPatients with a history of previous invasive breast cancerXx_NEWLINE_xXDiagnosis of LGS carcinoma of the ovary, fallopian tube or primary peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma), confirmed histologically and verified by central pathology review.Xx_NEWLINE_xXHistologically confirmed invasive cancer of the breast.Xx_NEWLINE_xXParticipants must have histologically confirmed invasive breast cancer; all histologic subtypes are eligibleXx_NEWLINE_xXHistory of another “active” invasive primary cancer requiring ongoing treatmentXx_NEWLINE_xXHistologically confirmed invasive breast carcinomaXx_NEWLINE_xXHistory of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situXx_NEWLINE_xXHistologically confirmed Stage I to III invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.Xx_NEWLINE_xXPatients with synchronous contralateral invasive breast cancer are excludedXx_NEWLINE_xXPatients may have had prior non-invasive (ductal carcinoma in situ [DCIS]) cancer if there has been no recurrence; prior ipsilateral invasive cancer also allowed if more than 5 years previousXx_NEWLINE_xXDuctal carcinoma in situ (DCIS) or invasive ductal, medullary, papillary, mucinous (colloid), or tubular histologiesXx_NEWLINE_xXPatients with invasive or extensive in-situ lobular carcinoma or non-epithelial breast malignancies such as sarcoma or lymphomaXx_NEWLINE_xXAny previously treated contralateral invasive breast carcinoma or synchronous contralateral breast carcinomaXx_NEWLINE_xXThe participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.Xx_NEWLINE_xXDiagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situXx_NEWLINE_xXPathologic T stage of Tis, T1, or T2 with total size of tumor =< 3 cm (this size criteria applies to both pure ductal carcinoma in situ [DCIS] and invasive tumors)Xx_NEWLINE_xXFor patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCISXx_NEWLINE_xXHistory of prior invasive or in situ cancer in either breastXx_NEWLINE_xXCore biopsy should definitively demonstrate invasive carcinomaXx_NEWLINE_xXWomen with non-invasive disease or microinvasion are not eligibleXx_NEWLINE_xXBiopsy-proven, invasive carcinoma of the cervixXx_NEWLINE_xXInitial histological diagnosis of muscle invasive urothelial carcinomaXx_NEWLINE_xXHistory of breast cancer (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]) prior to the current diagnosisXx_NEWLINE_xXPatients with histologically proven invasive squamous cell carcinoma arising from the true vocal cordXx_NEWLINE_xXPrevious muscle-invasive (i.e., stage T2 or higher) transitional-cell carcinoma of the bladderXx_NEWLINE_xXParticipants must have a confirmed or suspected invasive or non-invasive bladder tumor (initial or recurrent) discovered on cystoscopy or radiologic imaging performed within 120 days of randomizationXx_NEWLINE_xXPresence of other active cancers, or history of treatment for invasive cancer ?3 yearsXx_NEWLINE_xXductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, orXx_NEWLINE_xXClinical T2-T4c, any N, M0 invasive ER+ (Allred score of 6-8) and HER2 negative (0 or 1+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] negative for amplification) breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node; \r\n* Note: if the patient has invasive or ductal carcinoma in situ (DCIS) in the contralateral breast the patient is not eligible for this studyXx_NEWLINE_xXInvasive cancer or DCIS in the contralateral breastXx_NEWLINE_xXCore needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing invasive mammary cancer (with or without concomitant ductal carcinoma or lobular carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and \NOS\ (not otherwise specified); invasive lobular cancer is excludedXx_NEWLINE_xXAge > 70 years with invasive breast cancer clinical size =< 3 cm OR\r\nAge 50 - 70 years with invasive breast cancer clinical size =< 1.5 cm OR\r\nAge >= 50 years and postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =< 1.5 cm (clinical tumor size will be determined by pre-operative breast imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of multiple measurements, the largest recorded single dimension will be used to determine eligibility)Xx_NEWLINE_xXInitial core biopsy showing invasive lobular cancerXx_NEWLINE_xXEGFR GERMLINE MUTATION TESTING: One of the following criteria:\r\n* Personal history of invasive lung cancer or one of the pre-invasive histologies associated with the development of lung cancer (adenocarcinoma in situ [AIS], minimally invasive adenocarcinomas [MIA] or atypical adenomatous hyperplasia [AAH]) and more than two affected family members with invasive lung cancer or one of the pre-invasive histologies associated with the development of lung cancer; OR\r\n* First-degree relatives of an individual enrolled in the study with a known EGFR germline mutationXx_NEWLINE_xXHistologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder with carcinoma in-situ (CIS)Xx_NEWLINE_xXPathologically confirmed invasive cancer of the breastXx_NEWLINE_xXDiagnosis of invasive adenocarcinoma of the breast made by core needle biopsyXx_NEWLINE_xXSynchronous bilateral breast cancer (invasive or ductal carcinoma in situ [DCIS])Xx_NEWLINE_xXPrior history of invasive breast cancer (patients with a history of DCIS or lobular carcinoma in situ [LCIS] are eligible)Xx_NEWLINE_xXAny prior treatment for the current primary invasive breast cancerXx_NEWLINE_xXBilateral invasive breast cancerXx_NEWLINE_xXBilateral invasive breast cancer.Xx_NEWLINE_xXPrior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.Xx_NEWLINE_xXDuctal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breastXx_NEWLINE_xXAny prior treatment for primary invasive breast cancerXx_NEWLINE_xXBilateral invasive, multicentric, or metastatic breast cancerXx_NEWLINE_xXUse of minimally invasive surgery.Xx_NEWLINE_xXCuratively treated ductal carcinoma in situ of the breast;Xx_NEWLINE_xXHave a history of muscle invasive bladder cancerXx_NEWLINE_xXPatients with multiple foci of invasive cancer in the same breast are eligible if any single lesion meets the above size criteria and all sampled lesions are histologically similar (whether radiographically detected lesions separate from the target lesion are sampled for histologic evaluation is left to the discretion of the treating physicians); the presence of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) in either breast will not render a patient ineligible; patients with a small focus of invasive cancer detected the contralateral breast (clinical T1N0) are eligible, however only the histologic response in the breast containing the target lesions will be considered in determining the patient’s pathologic responseXx_NEWLINE_xXAdvanced (T1N1-4/T2-3 N any) invasive cancer in the contralateral breastXx_NEWLINE_xXPrior or concurrent invasive malignant disease, unless in complete remission for more than three years.Xx_NEWLINE_xXPatients must have newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastasesXx_NEWLINE_xXAny prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral ductal breast carcinoma in situ (DCIS) treated with radiation therapy; (Patients with synchronous or previous ipsilateral lobular breast carcinoma in situ [LCIS] are eligible)Xx_NEWLINE_xXSynchronous or previous contralateral invasive breast cancer; (patients with contralateral DCIS not treated with radiation are eligible)Xx_NEWLINE_xXDiagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy)Xx_NEWLINE_xXInclusion Criteria - Phase 1 (Cohort A):\n\n - Female patient ? 18 years\n\n - Patient must be postmenopausal, verified by 1 of the following:\n\n - Bilateral surgical oophorectomy\n\n - No spontaneous menses > 1 year\n\n - No menses for < 1 year with FSH and estradiol levels in postmenopausal range\n\n - Postmenopausal women with primary invasive breast cancer, histologically confirmed by\n core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone\n (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10%\n or more nuclear staining of the invasive component of the tumor\n\n - Stage IV disease (as defined by the AJCC Staging Manual, 6th Edition, 2002); or\n locally relapsed, unresectable disease\n\n - Measurable or evaluable disease according to RECIST criteria (see appendix VII)\n\n - Both HER2-positive and HER2-negative disease (as defined by IHC or by fluorescence in\n situ hybridization [FISH]). HER2+ must have had prior treatment with trastuzumab\n and/or lapatinib.\n\n - ECOG performance status 0-2 (see appendix VI)\n\n - Patients are suitable candidates for treatment with anastrozole (patients may have had\n any prior endocrine therapy or prior chemotherapy for treatment of their disease,\n either as adjuvant therapy, or as treatment for advanced disease). There is no\n restriction on the number of prior regimens in the phase I cohort A.\n\n - Patient is accessible and willing to comply with treatment and follow-up\n\n - Patient is willing to provide written informed consent prior to the performance of any\n study-related procedures\n\n - Required laboratory values\n\n - Absolute neutrophil count ? to 1.5 x 10^9/L\n\n - Hemoglobin ? to 9.0 g/dL\n\n - Platelet count ? to 100 x 10^9/L\n\n - Creatinine ? 1.5 mg/dL\n\n - Total bilirubin ? 1.0 x upper limit of normal (ULN)\n\n - Alkaline phosphatase and AST/ALT within protocol parameters. In determining\n eligibility, the more abnormal of the two values (AST or ALT) should be used.\n\n Inclusion Criteria - Phase 2 (Cohort B):\n\n - Female patient ? 18 years\n\n - Patient must be postmenopausal, verified by 1 of the following:\n\n - Bilateral surgical oophorectomy\n\n - No spontaneous menses ? 1 year\n\n - No menses for < 1 year with FSH and estradiol levels in postmenopausal range\n\n - Postmenopausal women with primary invasive breast cancer, histologically confirmed by\n core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone\n (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10%\n or more nuclear staining of the invasive component of the tumor. Patients may have\n bilateral or multifocal invasive breast cancers. The patient may have concurrent DCIS\n in either breast but the DCIS will not be measured as part of the study endpoints.\n\n - Tumor size ? 2 cm\n\n - Tumor measurable either by clinical examination, mammography, MRI, or ultrasound\n\n - HER2-negative disease (as defined by fluorescence in situ hybridization [FISH] or by\n IHC)\n\n - ECOG performance status 0-1 (see Appendix VI)\n\n - Patient is accessible and willing to comply with treatment and follow-up\n\n - Patient is willing to provide written informed consent prior to the performance of any\n study-related procedures\n\n - Required laboratory values\n\n - Absolute neutrophil count ? 1.5 x 10^9/L\n\n - Hemoglobin ? 9.0 g/dL\n\n - Platelet count ? 70 x 10^9/L\n\n - Creatinine ? 1.5 mg/dL\n\n - Total bilirubin ? 1.5 x upper limit of normal (ULN)\n\n - Alkaline phosphatase and AST/ALT ? 1.5 x upper limit of normal (ULN)\n\n Exclusion Criteria - Phase 1 (Cohort A):\n\n - Concurrent therapy with any other non-protocol anti-cancer therapy\n\n - Any agent with estrogenic or putatively estrogenic properties, including herbal\n preparations, must be stopped at least one week prior to registration.\n\n - Ongoing, chronic administration of bisphosphonate therapy is allowed so long as\n such treatment was ongoing at the time of study entry.\n\n - Current therapy with hormone replacement therapy, or any hormonal agent such as\n raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be\n stopped prior to randomization)\n\n - Presence of neuropathy ? grade 2 (NCI-CTC version 3.0) at baseline\n\n - History of any other malignancy within the past 5 years, with the exception of\n non-melanoma skin cancer or carcinoma-in-situ of the cervix\n\n - Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100],\n history of myocardial infarction or stroke within 6 months, unstable angina), New York\n Heart Association (NYHA) Grade II or greater congestive heart failure, or serious\n cardiac arrhythmia requiring medication\n\n - Active, uncontrolled infection requiring parenteral antimicrobials\n\n - A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 or their\n excipients\n\n - Evidence of bleeding diathesis or coagulopathy.\n\n - Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a\n 24 hr period.\n\n - Since AZD0530 is a substrate and inhibitor of CYP3A4, patients requiring medication\n with drugs listed in Appendix XI should be excluded from study.\n\n - Any evidence of severe or uncontrolled systemic medical or psychiatric conditions\n (e.g. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse,\n parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac\n conditions which make it undesirable for the patient to participate in the study or\n which could jeopardize compliance with the protocol\n\n - Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by\n pulse oximetry, interstitial pulmonary infiltrates on high resolution CT scan prior to\n study entry and/or symptomatic pulmonary (pleural or parenchymal) metastasis.\n\n Exclusion Criteria - Phase 2 (Cohort B):\n\n - Prior chemotherapy, endocrine therapy or radiotherapy for the presenting breast\n cancer. Prior incidence and treatment of contralateral invasive or non-invasive breast\n cancer is not an exclusion criterion.\n\n - Inflammatory breast cancer, clinically defined as the presence of erythema or\n induration involving one-third or more of the breast, or pathologically defined as\n dermal lymphatic invasion\n\n - Prior excisional biopsy or complete resection of the primary invasive tumor (prior\n sentinel node biopsy allowed)\n\n - Prior ipsilateral radiation therapy for invasive or non-invasive breast cancer\n\n - Distant metastasis is an exclusion criterion - Isolated ipsilateral supraclavicular\n node involvement and/or direct invasion of the primary tumor into skin is allowed\n\n - Concurrent therapy with any other non-protocol anti-cancer therapy\n\n - Any agent with estrogenic or putatively estrogenic properties, including herbal\n preparations, must be stopped at least one week prior to registration\n\n - Current therapy with hormone replacement therapy, or any hormonal agent such as\n raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be\n stopped for one week prior to randomization)\n\n - Presence of neuropathy ? grade 2 (NCI-CTC AE version 3.0) at baseline\n\n - History of any other malignancy within the past 5 years, with the exception of\n non-melanoma skin cancer or carcinoma-in-situ of the cervix\n\n - Clinically significant cardiovascular disease (e.g. history of myocardial infarction\n or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade\n II or greater congestive heart failure, or serious cardiac arrhythmia requiring\n medication\n\n - Active, uncontrolled infection requiring parenteral antimicrobials\n\n - A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 or their\n excipients\n\n - Evidence of bleeding diathesis or coagulopathy\n\n - Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a\n 24 hr period.\n\n - AZD0530 is a substrate and inhibitor of CYP3A4. Since concurrent administration of\n AZD0530 with other CYP3A4 substrates has been shown to be well tolerated, continuation\n or initiation of medically indicated drugs that are substrates of CYP3A4 is permitted\n at MD discretion. Drugs listed in Appendix XI that are known to strongly induce or\n inhibit CYP3A4 activity should be discontinued prior to study entry and should not be\n initiated during protocol treatment.\n\n - Any evidence of severe or uncontrolled systemic psychiatric or medical conditions (eg.\n Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal\n lung disease]) or current unstable or uncompensated respiratory or cardiac conditions\n which make it undesirable for the patient to participate in the study or which could\n jeopardize compliance with the protocol\n\n - Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by\n pulse oximetry prior to study entry and/or symptomatic pulmonary (pleural or\n parenchymal) disease.\n\n - Subjects unwilling or unable to undergo breast MRI as required by protocol will be\n excluded from studyXx_NEWLINE_xXPatients with history of breast cancer greater than 5 years from initial diagnosis and are disease free are eligible for the study; patients with history of ductal carcinoma in situ (DCIS) are eligible if there were treated with surgery aloneXx_NEWLINE_xXHistologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular); in-situ disease alone is not allowedXx_NEWLINE_xXNo prior history of ipsilateral breast cancer (invasive disease or ductal breast carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowedXx_NEWLINE_xXNo history of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowedXx_NEWLINE_xXDiagnosis of breast or gynecologic cancer, all types (examples are ductal carcinoma in situ [DCIS], lobular carcinoma in situ[LCIS], invasive breast, ovarian, endometrial, vulvar, cervical and vaginal)Xx_NEWLINE_xXHistory of invasive breast cancerXx_NEWLINE_xXPatients with a history of prior (ipsilateral [ipsi]- and/or contralateral) invasive BCXx_NEWLINE_xXDiagnosed with clinical or pathologic stage I?III invasive breast cancer with TX?T3 tumorXx_NEWLINE_xXDiagnosis of ductal carcinoma in situ (DCIS) or stage I, II, or III breast cancerXx_NEWLINE_xXEver had a diagnosis of invasive or microinvasive breast cancerXx_NEWLINE_xXParticipants who have been diagnosed with ductal carcinoma in-situ (DCIS) or invasive breast cancer and have been offered lumpectomy or mastectomy for surgical treatment will be considered for the studyXx_NEWLINE_xXOther cancers diagnosed within the last 5 years (in situ and/or invasive cancers)Xx_NEWLINE_xXDuctal carcinoma in situ (DCIS) diagnosisXx_NEWLINE_xXPatients must have evidence of histologically confirmed invasive breast cancer, stage I, II or III, and be at least 2 years post diagnosisXx_NEWLINE_xXDiagnosis of any invasive gynecologic cancer without evidence of diseaseXx_NEWLINE_xXAmbulatory outpatients with breast (including ductal carcinoma in situ [DCIS]) cancerXx_NEWLINE_xXPatients with a documented history of invasive fungal infection (IFI) within the previous 30 days are not eligibleXx_NEWLINE_xXWithin 90 days of enrollment:\r\n* Patients with a proven or probable invasive mold infection are not eligible\r\n* Patients with an incompletely treated invasive yeast infection are not eligible\r\n* Patients with an elevated galactomannan level (>= 0.5 index) within 30 days prior to time of enrollment (if performed) must have a full evaluation for invasive aspergillosis (including a negative chest computed tomography [CT] scan) during that time period to be eligible for enrollmentXx_NEWLINE_xXElective minimally invasive operationXx_NEWLINE_xXHistory of breast cancer, ductal breast carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS) (currently without evidence of malignant disease) OR a concern about taking estrogen for fear of breast cancerXx_NEWLINE_xXInvasive or ductal carcinoma in situ (DCIS) breast cancerXx_NEWLINE_xXDiagnosed with invasive malignancy including: breast, gastrointestinal track, female or male genitourinary system, sarcoma of bone or soft-tissue, leukemia and lymphomaXx_NEWLINE_xXNon-metastatic histologically confirmed primary invasive breast carcinomaXx_NEWLINE_xXThe patient must have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomyXx_NEWLINE_xXSurgical margins are negative for invasive or non-invasive breast cancerXx_NEWLINE_xXDiagnosis of: invasive breast cancer (stage I-III), ductal carcinoma in situ, lobular carcinoma in situ, lobular carcinomaXx_NEWLINE_xXHistologically-confirmed invasive breast cancer by Memorial Sloan-Kettering Cancer Center (MSKCC)Xx_NEWLINE_xXPatients must be women with histologically confirmed primary invasive carcinoma of the breast (stage I, II, or III) with no evidence of metastatic disease (M0) or with histologically confirmed ductal carcinoma in situ (DCIS); if patient has undergone breast cancer surgery, she must have recovered from all side-effects of surgeryXx_NEWLINE_xXPatients with histologically confirmed invasive breast cancer, stage I - IV, treated at Lyndon B. Johnson General Hospital in the Harris Health SystemXx_NEWLINE_xXPatient has diagnosis of biopsy-proven primary breast cancer or a diagnosis of pure ductal carcinoma in situ (DCIS) who will be undergoing intraoperative lymphatic mapping as part of their standard surgical planXx_NEWLINE_xXStage 0-III invasive carcinoma of the breastXx_NEWLINE_xXStage 1-4 invasive breast cancer that is histologically confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC)Xx_NEWLINE_xXSubjects with history of presumed or proven invasive fungal infection within 30 days of randomizationXx_NEWLINE_xXDiagnosed with operable invasive cancerXx_NEWLINE_xXPatients must not have previous personal history of breast cancer including ductal carcinoma in situXx_NEWLINE_xXHave had a prior biopsy diagnosed atypical lobular hyperplasia, atypical ductal hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ in the last 10 years; or have had multiple prior breast biopsies, regardless of histologyXx_NEWLINE_xXNo history of invasive cervical cancerXx_NEWLINE_xXWomen who have a core biopsy or excisional biopsy containing invasive cancerXx_NEWLINE_xXWomen with a previous history of invasive breast cancer or bilateral ductal carcinoma in situ (DCIS) or current untreated DCIS; women with a history of cancer within the last 3 years, except for non-melanoma skin cancer; women with unilateral DCIS (with or without radiation therapy) are eligible as long as they have an unaffected breastXx_NEWLINE_xXInvasive breast cancer; areas of microinvasion or suspicious for microinvasion on the core biopsy is allowedXx_NEWLINE_xXHistory of prior ductal carcinoma in situ (DCIS) treated within the past two years; patients completing all treatment for a previous diagnosis of DCIS over two years prior to the current diagnosis are eligibleXx_NEWLINE_xXFOCUS GROUP: No prior breast cancer, invasive or ductal breast carcinoma in situ (DCIS) (ever), no prior lobular breast carcinoma in situ (LCIS) diagnosis, no BRCA mutation carriers or genetic counseling visitsXx_NEWLINE_xXBETA/USABILITY TESTING AND THE TRIAL: Not able to speak and read English; cognitive impairment that precludes informed consent, history of LCIS (lobular carcinoma in situ), prior cancer diagnosis (including DCIS [ductal carcinoma in situ] and invasive breast cancer), known BRCA1/2 family mutation, or previous receipt of cancer genetic counselingXx_NEWLINE_xXHistologically confirmed invasive breast cancer or Ductal Carcinoma In Situ (DCIS)Xx_NEWLINE_xXParticipants must be at high risk as defined by a history of breast cancer (invasive or ductal breast carcinoma in situ [DCIS]) and be at least 5 years out from diagnosis, or lobular carcinoma in situ (LCIS), or proliferative benign breast disease such atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH) or genetic test confirmation of BRCA 1/2 mutation carrier or have a breast cancer risk assessment > 1.7% in 5 years or a lifetime risk > 20%Xx_NEWLINE_xXNo evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator; diagnosis of invasive cancer must be at least 5 years prior to initiation on trialXx_NEWLINE_xXPrior history of histologically confirmed bilateral invasive breast cancerXx_NEWLINE_xXAt high risk of developing breast cancer (history of ductal carcinoma in situ [DCIS], lobular carcinoma in situ [LCIS], atypical ductal hyperplasia [ADH], Gail 5 year risk > 1.66% or lifetime risk > 20%)Xx_NEWLINE_xXPatients with a previous diagnosis of invasive breast cancer who are less than 3 years from diagnosisXx_NEWLINE_xXA prior biopsy showing lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer, or individual with breast cancer 1 or 2, early onset gene (BRCA1/2) deleterious mutationXx_NEWLINE_xXHistory of any of the following:\r\n* Invasive breast cancer\r\n* Ductal breast carcinoma in situ (DCIS)\r\n* Flat epithelial atypiaXx_NEWLINE_xXAny current invasive cancer diagnosisXx_NEWLINE_xXDCIS or previous invasive ductal carcinoma.Xx_NEWLINE_xXPositive margins on ink after definitive surgery either for ductal carcinoma in situ (DCIS) or invasive cancerXx_NEWLINE_xXMale and female patients who present to the urology clinic for recurrent non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC) and are candidates for radical cystectomy will be screened for participationXx_NEWLINE_xXWomen scheduled for unilateral or bilateral mastectomy for breast cancer therapy, pathology confirmed stage 0-II (including ductal carcinoma in situ), or prophylaxis (breast cancer 1, early onset [BRCA1]/2 mutation carriers, women with strong family history or lobular carcinoma in situ or other conditions where prophylactic mastectomy has been elected)Xx_NEWLINE_xXA prior biopsy indicating proliferative breast disease, atypical hyperplasia, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)Xx_NEWLINE_xXInvasive cancer diagnosis within five years, excluding squamous or basal cell skin cancer; subjects with DCIS or stage I invasive cancer are eligible if they are at least 2 months from radiation or surgery and at least 1 year (yr) from chemotherapy or hormone therapy; RPFNA will be performed on the contralateral breast only in these instancesXx_NEWLINE_xXPrior colon cancer (>= 3 years out from invasive cancer)Xx_NEWLINE_xXHistory of invasive carcinoma =< 5 years (except subjects with Dukes A/B1 carcinoma =< 5 years prior to pre-registration or any stage of colon cancer if >= 3 years post surgical resection)Xx_NEWLINE_xXNew diagnosis of invasive carcinomaXx_NEWLINE_xXHas a proven or probable invasive fungal infectionXx_NEWLINE_xXDiagnosed with a first primary invasive ER+ breast cancer (stages I-IIIa)Xx_NEWLINE_xXPatients must have high risk non-muscle invasive urothelial bladder carcinoma (Tis, Ta high grade [HG], or T1) that is pathologically confirmed by the Memorial Sloan Kettering Department of Pathology or a documented history of TaHG or T1 non-muscle invasive urothelial bladder tumorsXx_NEWLINE_xXThe patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to IIIXx_NEWLINE_xXPrior excisional biopsy of the primary invasive breast cancerXx_NEWLINE_xXSubject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breastXx_NEWLINE_xXSubject has invasive lobular cancerXx_NEWLINE_xXUpon clinical exam and pre-operative imaging by mammogram +/- MRI, two or three foci of biopsy proven breast cancer separated by >= 2 cm of normal breast tissue; foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS); no more than 2 quadrants with biopsy proven breast cancer; Note: the shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained; Note: patient is eligible for study if lesion is not visualized on all imaging modalities (i.e., any of the lesion (s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI); ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram +/- MRI only; fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy; patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesionXx_NEWLINE_xXPatients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the criteria is met:\r\n* An area of atypia > 2 cm from the index lesion excised at the time of cancer operation is upgraded to DCIS or invasive carcinoma thereby identifying MIBC OR\r\n* Patient underwent resection of two or three foci of malignancy by breast conservation surgery with a minimum of one invasive focus of breast cancer and a minimum of 2 cm of normal breast tissue between the lesions on final pathologyXx_NEWLINE_xXPrior history of ipsilateral breast cancer (DCIS, LCIS [lobular cancer in situ] or invasive)Xx_NEWLINE_xXPrior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed)Xx_NEWLINE_xXParticipants must have a history of histologically-confirmed stage I-III invasive breast cancer or ductal carcinoma in situ (DCIS), Paget’s disease, lobular carcinoma in situ (LCIS), or proliferative benign breast diseaseXx_NEWLINE_xXNo evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigatorXx_NEWLINE_xXA history of histologically-confirmed bilateral invasive breast cancerXx_NEWLINE_xXPost-menopausal woman with a diagnosis of invasive breast cancer (T1-3,pN0-2,M0) for which definitive surgery was performed during the previous 36 months.Xx_NEWLINE_xXPathological diagnosis of invasive adenocarcinoma of the breastXx_NEWLINE_xXHistory of prior breast cancer, ductal carcinoma in situXx_NEWLINE_xXHGAIN (e.g., anal intraepithelial neoplasia [AIN] 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) or invasive carcinoma at pre-entry on biopsy, or participant has a history of invasive carcinoma or any prior anal cytology result of HSIL or ASC-HXx_NEWLINE_xXPatients with previous contralateral invasive breast cancer treated with anti-cancer therapy are eligibleXx_NEWLINE_xXPatients with synchronous ipsilateral invasive breast cancer or any prior history of ipsilateral invasive breast cancer; (patients with previous ipsilateral/contralateral DCIS or previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible)Xx_NEWLINE_xXPatients with invasive lobular carcinomaXx_NEWLINE_xXNo patients with previous ipsilateral or contralateral invasive breast cancer or ductal carcinoma in situ (DCIS)Xx_NEWLINE_xXPersonal history and/or concomitant diagnosis of invasive breast cancer or DCISXx_NEWLINE_xXDiagnosed with histologically-proven invasive breast cancerXx_NEWLINE_xXPatients undergoing a partial mastectomy OR mastectomy for the treatment of an invasive or non-invasive breast malignancyXx_NEWLINE_xXDiagnosis of biopsy-proven invasive breast cancer measuring at least 1.5 cm in diameter by any imaging modalityXx_NEWLINE_xXBiopsy-proven PR-positive (sample size [N]=23) or PR-negative (N=5) invasive breast cancer, as defined by University of Wisconsin (UW) Health PathologyXx_NEWLINE_xXCore needle biopsy positive for invasive breast cancer or ductal breast carcinoma in situ (DCIS)Xx_NEWLINE_xXPrevious surgery for DCIS or invasive cancerXx_NEWLINE_xXParticipants who are candidates for neoadjuvant chemotherapy or neoadjuvant endocrine therapy for the treatment of newly diagnosed, invasive breast cancerXx_NEWLINE_xXParticipants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breastXx_NEWLINE_xXHave been diagnosed with a HER2+ invasive cancer of the breastXx_NEWLINE_xXGroup I: Diagnosis of histologically confirmed invasive breast cancerXx_NEWLINE_xXGroup II: Diagnosis of histologically confirmed invasive breast cancerXx_NEWLINE_xXWomen undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer (ductal carcinoma in situ [DCIS] or any invasive breast cancer)Xx_NEWLINE_xXPatient must have a tissue diagnosis of invasive breast carcinomaXx_NEWLINE_xXPatient has concurrent invasive bilateral breast malignancies or multicentric diseaseXx_NEWLINE_xXPatients must have pathologically confirmed diagnosis of unilateral ductal carcinoma in situ with no evidence of microinvasive or invasive disease obtained by core needle biopsy within 4 months of registration; if the core biopsy describes “suspicion of microinvasion”, patients remain eligible; patients diagnosed by surgical excision are not eligible; patients with synchronous bilateral disease (i.e.,\r\nsynchronous DCIS or invasive cancer) are not eligible\r\n* Patients will be staged prior to registration according to the clinical staging criteria adapted from the American Joint Committee on Cancer (AJCC) Cancer Staging Data Forms of the AJCC Cancer Staging Manual, 7th Edition, 2009; Note: for consistency purposes, AJCC 7th Edition will continue to be used throughout the entire study enrollment periodXx_NEWLINE_xXPatients must not have previous ipsilateral invasive breast cancer or DCISXx_NEWLINE_xXPatient's most recent surgery was wide local excision with or without re-excision and for which there was obtained clear (>= 2 mm) margins at breast conserving surgery, and the pathology reveals pure DCIS; patients with invasive cancer or DCIS with microinvasion will not be registered on step 3, but will be followed for clinical outcomes\r\n* NOTE: if resection is documented to have reached pectoral fascia and deep margin is free but less than 2 mm, the patient is eligible\r\n* NOTE: if no residual DCIS is found on wide local excision as it was fully removed in core biopsy, the patient is eligible\r\n* NOTE: patients with lobular carcinoma in situ (LCIS) as well as DCIS are eligibleXx_NEWLINE_xXHistologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situXx_NEWLINE_xXHistologic diagnosis of invasive breast cancer or ductal carcinoma in situXx_NEWLINE_xXWomen presenting for evaluation at Memorial Sloan-Kettering Cancer Center (MSKCC) with biopsy proven invasive ductal cancer (IDC) or invasive lobular cancer (ILC)Xx_NEWLINE_xXPatient is scheduled for brain surgery and/or another invasive procedure within the time period of one month prior to 18F-FSPG administration. Minimally invasive needle biopsies are allowed.Xx_NEWLINE_xXPatients with DCIS or invasive breast cancer who are scheduled for a lumpectomy or mastectomy and are receiving surgical care from the Breast Surgery Department at Columbia Medical CenterXx_NEWLINE_xXPatients diagnosed with unilateral DCIS or invasive breast cancerXx_NEWLINE_xXPatients with invasive, inflammatory breast cancer or distant metastases will be excluded from participating in this studyXx_NEWLINE_xXHave newly diagnosed infiltrating ductal carcinoma of the breastXx_NEWLINE_xXSubjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (DCIS).Xx_NEWLINE_xXIpsilateral biopsy-proven invasive breast cancer < 5 cm in maximal dimension by ultrasound or mammographyXx_NEWLINE_xXPatients unwilling to undergo serial non-invasive imagingXx_NEWLINE_xXA new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-IIIXx_NEWLINE_xXWomen with histologically proven invasive breast cancer and no distant metastases and;Xx_NEWLINE_xXPatient must have a histologic diagnosis of invasive breast cancerXx_NEWLINE_xXThe patient is diagnosed with non-invasive breast cancer, benign breast disease, or other than stage II or stage III invasive breast cancerXx_NEWLINE_xXDiagnosed with incident, primary, invasive, ductal or lobular, or other epithelial malignancy, clinical stage I or II, ER positive or negative breast cancer, or ductal carcinoma in situ (DCIS)Xx_NEWLINE_xXPatients must have histologically confirmed invasive breast cancerXx_NEWLINE_xXNewly diagnosed primary breast cancer prior to initial definitive surgical treatment, including in situ and invasive cancer, stages 0 – III; pathologic confirmation of diagnosis is requiredXx_NEWLINE_xXPHASE II: Women with a history of breast cancer (invasive and non-invasive) and those diagnosed with Paget’s disease, inflammatory breast cancer or a phyllodes tumorXx_NEWLINE_xXDiagnosis of invasive breast cancerXx_NEWLINE_xXPrior treatment with radiation therapy to the ipsilateral breast or chest wall\r\n* Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry\r\n* Prior invasive or in-situ carcinoma of the breast (-prior lobular breast carcinoma in situ [LCIS] is eligible)\r\n* Diagnosis of ductal breast carcinoma in situ (DCIS)Xx_NEWLINE_xXHave a history of invasive (>= T1) bladder cancerXx_NEWLINE_xXA primary diagnosis of stage 0 (ductal carcinoma in situ), 1, 2, or 3a breast cancerXx_NEWLINE_xXHistologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or a combination of invasive breast cancer and DCIS. Subjects who had diagnostic surgical biopsies are excluded from participation.Xx_NEWLINE_xXPatients with a prior diagnosis of non-muscle invasive, ?T1, urothelial cell\n carcinoma of the bladder scheduled to undergo surveillance cystoscopy.Xx_NEWLINE_xXPatients who have had a cystectomy or prior diagnosis of muscle invasive disease (T2\n or greater)Xx_NEWLINE_xXDiagnosed with invasive adenocarcinoma, or DCIS for which a SLNB is the recommended standard of care, or breast cancer with all of the following conditions met:Xx_NEWLINE_xXConfirmed current or past diagnosis of invasive breast cancerXx_NEWLINE_xXHistologically or cytologically confirmed stage III-IV (non-metastatic) SCCHN as defined by American Joint Committee on Cancer (AJCC); nasopharyngeal cancer patients will be excluded; note that in rare instances, a cancer may be clearly invasive on imaging, but pathology may not be definitive (e.g. in-situ carcinoma); in such cases, the patient will be eligible if the unanimous opinion of the institutional tumor board is that the situation is definitive for invasive SCCHNXx_NEWLINE_xX