[c09aa8]: / clusters / 9knumclustersv2 / clust_1572.txt

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The maximum time requirement between surgery and randomization must be:\r\n* months ( days) if no adjuvant chemotherapy was administered\r\n* months ( days) if adjuvant chemotherapy was administered\r\n* months ( days) if adjuvant chemotherapy and radiation therapy were administered
Patients must have completed any prior adjuvant chemotherapy or radiation therapy or more weeks ( or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization\r\n* NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study\r\n* NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted
Complete recovery from surgery and standard post-operative therapy (if required); patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least days, the maximum time requirement between surgery and randomization must be days if no adjuvant chemotherapy was administered, days if adjuvant chemotherapy was administered, and days if adjuvant chemotherapy and radiation therapy was administered
Patients must have adequately recovered from surgery and any administered chemotherapy/radiotherapy at the time of randomization (NOTE: adjuvant chemotherapy and/or radiation is not required)\r\n* Minimum time between date of surgery and randomization is weeks ( days)\r\n* Maximum time allowed between surgery and randomization:\r\n** months ( days) if no chemotherapy is administered\r\n** months ( days) if adjuvant chemotherapy was administered\r\n** months ( days) if adjuvant chemotherapy and radiation therapy was administered
Patients must have completed and recovered from any adjuvant chemotherapy or more weeks prior to randomization ( weeks for mitomycin and nitrosoureas; weeks for post-operative radiation therapy) (NOTE: adjuvant chemotherapy and/or radiation is not required)
No postoperative/adjuvant systemic therapy
The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than days
If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved
Patients may receive post-operative (adjuvant) chemotherapy for up to weeks of duration (e.g. cycles of capecitabine as in the CREATE-X trial) after completion of surgery at the discretion of the treating physician; patients must have resolution of adverse event(s) of the most recent prior chemotherapy to grade or less, except alopecia and =< grade neuropathy which are allowed; patients that have received adjuvant chemotherapy must be registered to screening within days after completing treatment
Patients must have completed their final breast surgery (rendering them free from disease) with clear resection margins for invasive cancer and DCIS within the following timelines:\r\n* days prior to screening registration for patients not receiving post-operative (adjuvant) chemotherapy OR\r\n* days prior to screening registration for patients who have received post-operative (adjuvant) chemotherapy\r\nPatients who receive postoperative chemotherapy may receive radiation therapy before or after the chemotherapy; a short course of reduced dose chemotherapy concomitant with radiation for radiation sensitization is not considered to be adjuvant chemotherapy; positive margins are allowed only if the surgical team of the patient deems further resection impossible
Interval between the last surgery for breast cancer (including re-excision of margins) or the completion of adjuvant chemotherapy and study enrollment must be =< days (ie, a maximum of weeks)\r\n* Note: Radiotherapy must begin within weeks following the last surgery for breast cancer or the last dose of adjuvant chemotherapy
Patients must not have received prior chemotherapy except for the following circumstances; gemcitabine and capecitabine chemotherapy given in the adjuvant setting is allowed if the recurrence is greater than months from the completion of chemotherapy; radiation sensitizing doses of -fluororuracil or capecitabine are allowed as part of adjuvant treatment and recurrence must be documented greater than months from the completion of adjuvant therapy
Any prior treatment for metastatic breast cancer (excluding radiation therapy for the purpose of ovarian ablation). Note: prior adjuvant therapy with trastuzumab and pertuzumab is permitted after a -month window following completion of adjuvant therapy has passed
Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to cycles of consolidation as described above
Must have completed definitive treatment that included surgical removal of the clinically detected MCC metastases (with/without adjuvant radiation therapy as determined by the treating investigator)
For patients with MBC, prior adjuvant chemotherapy and trastuzumab more than or equal to months prior to enrollment are allowed
ADJUVANT COHORT: At least weeks post completion of adjuvant chemotherapy and radiation therapy if indicated
ADJUVANT COHORT: Patients who already started on adjuvant hormonal therapy are eligible under the following conditions:\r\n* For the patients who enrolled in the initial cohorts and derived benefit from neoadjuvant PD (CD Ki > .% and CD Ki =< .%), adjuvant PD should be initiated as soon as possible if adjuvant hormonal therapy has been initiated and the patient has completed radiation if indicated\r\n* For patients who enrolled in the endocrine resistant cohort and derived benefit from neoadjuvant PD (CD Ki =< %), adjuvant PD should be initiated within months or sooner after initiation of adjuvant hormonal therapy.
Part A: Subjects must have one of the histologically-confirmed solid malignancies listed below, must be clinically disease-free at study entry (i.e., subjects in the adjuvant setting). Subjects will be permitted to complete any standard of care adjuvant therapy prior to study entry, and those not eligible for any standard of care adjuvant treatment, or who decline such treatment, are permitted to consent to this study, as long as all treatment options have been transparently disclosed and documented in the Subject's medical record
progressed during or within months of completing adjuvant chemotherapy. Note: Generally, treatments that are separated by an event of progression are considered different regimens.
Prior chemotherapy for prostate cancer (upfront, adjuvant, etc.) is allowed as long as it was not given for hormone-refractory disease
Adjuvant chemotherapy or radiation therapy for UC following surgical resection
SPECIFIC FOR INITIATING ADJUVANT PEMBROLIZUMAB: Patient is receiving adjuvant radiation after salvage surgery
No prior adjuvant chemotherapy within year of the first treatment day if there is recurrent disease
Previous chemotherapy except adjuvant treatment with progression of disease documented ? months after end of adjuvant treatment
Subjects must have finished adjuvant therapy, which can include chemotherapy and/or chemoradiation therapy or have been determined to be unable to take adjuvant therapy; although patients will be expected to complete chemoradiation or chemotherapy per physician recommendations, patients who are unable to complete chemotherapy +/- radiation therapy secondary to dose limiting toxicities will be eligible provided they meet study criteria
Subjects enrolled due to node positive (+) disease or R resection must be able to undergo randomization within months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy; patients enrolling due to CA - elevations can enroll any time after adjuvant therapy has completed
PART I: Adults with HER+ bladder cancer in the adjuvant setting (adjuvant bladder cancer patients):\r\n* Tumor stage Ta, Tb, Ta, Tb and any node positive disease regardless of tumor stage\r\n* Tumors that are HER +, + or + by IHC or have a Vysis FISH result >= .\r\n* Status-post primary cystectomy with curative intent\r\n* May or may not have received neoadjuvant cisplatin-based combination chemotherapy per National Comprehensive Cancer Network (NCCN) guidelines\r\n* May or may not have received adjuvant radiotherapy or chemotherapy based on pathologic risk per NCCN guidelines\r\n* Greater than or equal to weeks s/p primary surgery with curative intent
If they are undergoing or have undergone in the past weeks ( days) any other therapy for their cancer, including radiation therapy and adjuvant therapy
Planned adjuvant focal therapy including additional radiation therapy to the brain
At eligibility recheck prior to vaccination, the above criteria must be met plus:\r\n* Completed adjuvant chemotherapy:\r\n** Initiation of adjuvant chemotherapy within weeks of surgery\r\n** Completion of at least months of adjuvant chemotherapy with gemcitabine/capecitabine or similar adjuvant chemotherapy at the discretion of the patients medical oncologist\r\n** Additional chemoradiation therapy as recommended by the patients medical oncologist\r\n** Reimaging within weeks of last dose of chemotherapy demonstrates no evidence of recurrent disease and CA - is less than . u/mL\r\n** Dose modifications and/or delays in adjuvant chemotherapy is at the discretion of the treating physician\r\n* Neoadjuvant chemotherapy is exclusionary\r\n* There is a week washout prior to day of vaccine for patients on daily systemic steroids at doses exceeding mg prednisone
Prior chemotherapy, hormonal and radiation therapy administered in the adjuvant setting will be allowed
Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within months of completion of adjuvant therapy; patients who progress more than months after completion of oxaliplatin containing adjuvant treatment must be retreated; patients who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed in the study
Completion of adjuvant locoregional radiation, if indicated, is required prior to starting study treatment
Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her-directed therapy) for the index malignancy at least weeks prior to study entry; all prior treatment-related toxicity must be resolved prior to study enrollment; concurrent receipt of adjuvant endocrine and bone modifying agents is allowed per standard of care guidelines
Patients must have received standard of care therapy with chemoradiation with temozolomide followed by adjuvant chemotherapy with temozolomide. Patients may have received one additional chemotherapy regimen (other than lomustine) in addition to adjuvant temozolomide prior to study entry (patients at either first or second recurrence are eligible).
Patients must have a histologically confirmed solid tumor that is surgically resected and have completed all planned adjuvant therapy or are not planned for any adjuvant therapy (including hormonal); patients must have fully recovered from surgery (i.e. sutures and drains have been removed); patients must have recovered from toxicity of prior chemotherapy and/or radiotherapy; patients may not have received chemotherapy in the prior four weeks; patients may have not received radiotherapy in the prior three weeks
Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study
History of another primary cancer diagnosis, treated with adjuvant chemotherapy
Patients who received adjuvant chemotherapy plus or minus radiation and had evidence of disease recurrence within months of completion of the adjuvant treatment are NOT eligible; if patients received adjuvant treatment and had disease recurrence after months, patients will be eligible
Any number or type of prior chemotherapy is allowed (patient may receive concurrent or adjuvant systemic therapy such as cetuximab at the discretion of the treating oncologic team)
Evidence of residual disease after surgery and SoC adjuvant therapies
No prior anticancer therapy for treatment of NSCLC other than standard post-operative adjuvant chemotherapy is permissible. Radiation: Patients with N disease only who receive adjuvant post-operative radiation therapy are eligible provided they meet the protocol specified timing criteria for surgery, adjuvant chemotherapy and randomization. Pre-operative radiation therapy is not permissible.
No plan to treat with adjuvant hormonal or radiation therapy
Patients with Tb, or T, or node positive disease will be excluded as they will be considered for adjuvant hormone therapy
Beginning adjuvant aromatase inhibitor therapy, with no previous use within the last weeks
Adjuvant therapy will not count towards prior treatment for metastatic disease, unless the patient relapsed within year of completing adjuvant therapy
Regarding prior malignancies:\r\n* Patients with a second active malignancy being actively treated at the time of screening with palliative or curative intent with cytotoxic chemotherapy, surgery, or radiation are ineligible\r\n* Patients with stage III or stage IV cancers of any type who have completed cytotoxic chemotherapy, surgery, or radiation in the adjuvant setting within years of screening are ineligible \r\n** For these patients, if more than three years have passed from the completion of adjuvant therapy to screening for the current protocol, then the patient is eligible for enrollment\r\n* However, patients with stage I or stage II cancers of any type, and who have completed cytotoxic chemotherapy, surgery, or radiation in the adjuvant setting by the time they are screening for the current protocol are eligible for enrollment\r\n* Patients who are being treated with adjuvant hormonal therapies, such as anti-estrogens or anti androgens, are eligible for enrollment provided they stop the hormonal therapy prior to starting the study medications\r\n* Finally, patients with cervical cancer in situ, in situ carcinoma of the bladder, or non-melanoma carcinoma of the skin that have been removed, are eligible for enrollment at any time\r\n* Questions regarding the inclusion of individual subjects should be directed to the principle investigator
Prior chemotherapy, adjuvant therapy, or radiotherapy for gastric cancer
Concurrent adjuvant cancer therapy.
Chemotherapy nave or prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least months after completing this adjuvant therapy)
Progressed during treatment or within months of completion of adjuvant therapy with an aromatase inhibitor
Must be deemed as a good candidate for adjuvant chemotherapy or chemoradiation (to start within months of surgery), in the opinion of the treating investigator. Plan must be to start adjuvant therapy within days of surgery; adjuvant treatment cannot begin more than days after surgery.
Prior adjuvant chemotherapy is allowed, as long as a minimum of months (for pancreatic cancer) and months (for colorectal cancer) has passed between the completion of adjuvant therapy and the start of first line therapy
Patients must not have received any adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial\r\n* NOTE: previous radiation therapy, including after the surgical resection, is allowed as long as days have elapsed between the radiation and initiation of this adjuvant systemic therapy
Receipt of a taxane for adjuvant therapy or metastatic disease in the last months
Recurrent disease within months after completion of adjuvant chemotherapy containing a weekly taxane
Any prior chemotherapy; the only exception will be patients with a history of stage I seminoma treated with adjuvant carboplatin for of cycles
Approved adjuvant therapies, which may include molecularly-targeted agents, IFN ?, and ipilimumab. Patients who received ipilimumab as adjuvant therapy must have a month washout before receiving any dosing on this study
At least weeks ( days) must have passed since the completion of adjuvant chemotherapy or radiotherapy
Patients may have received no prior chemotherapy for stage IV disease; patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than months have elapsed between the end of adjuvant therapy and registration
For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and st step registration must be between - days; for patients entering on the study who have already received up to months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between - days
Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed
The interval between completion of standard adjuvant chemotherapy and randomization must be less than or equal to days.
Concurrent adjuvant cancer therapy
Received a radiosensitizer or any additional adjuvant therapy during radiation therapy.
Must have started adjuvant FOLFOX chemotherapy within weeks of resection for colorectal carcinoma
Has received reradiation to recurrent disease (other than standard frontline adjuvant radiation therapy)
A concurrent active cancer that requires non-surgical therapy (e.g. chemotherapy, radiation, adjuvant therapy)
Patients must have undergone prior standard therapy of radiation therapy, and adjuvant chemotherapy
Disease that progressed during treatment or within months of completion of adjuvant therapy with tamoxifen and/or an aromatase inhibitor (AI).
Planned paclitaxel at a dose of mg/m^ intravenously (I.V.) given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of weeks without any other concurrent cytotoxic chemotherapy (NOTE: trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for poly adenosine diphosphate ribose polymerase [PARP] inhibitors), at the entering Academic and Community Cancer Research United (ACCRU) institution
Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of prostate cancer
Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer, other than standard concurrent chemoradiation as described above
Minimum of months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery and no evidence of recurrent disease; minimum of months since completion of adjuvant tamoxifen; current use of a third generation aromatase inhibitor [AI] (i.e., anastrozole, letrozole, exemestane) is permitted, provided that the participant has been on a stable dose for the past months
Subjects in the dose-escalation component can have had up to prior line of systemic therapy. Subjects with pancreatic carcinoma to be enrolled in the MTD expansion cohort must have untreated, measurable metastatic disease. Subjects for the MTD cohort may have received prior adjuvant gemcitabine or fluoropyrimidine based therapy in the adjuvant setting provided more than months has elapsed following completion of adjuvant therapy.
Any previous chemotherapy, biologic therapy, or investigational agent, except for adjuvant therapy or as radio-sensitizing agents limited to -fluorouracil/capecitabine and gemcitabine; patient must have completed adjuvant therapy no less than six months prior to accrual
Breast cancer patients must be currently on adjuvant aromatase inhibitors
Patients with a histologic diagnosis of adenocarcinoma of the upper gastrointestinal tract and hepatobiliary system, including patients with any of the following diagnoses and settings who are candidates to receive radiation with concurrent continuous infusion -FU or oral capecitabine chemotherapy:\r\n * Pancreatic adenocarcinoma (unresected or adjuvant)\r\n * Duodenal adenocarcinoma (unresected or adjuvant)\r\n * Extra-hepatic cholangiocarcinoma (unresected or adjuvant)\r\n * Gastric adenocarcinoma (unresected or adjuvant)\r\n * Gastroesophageal junction adenocarcinoma (adjuvant)
Documentation of positive diagnosis for any of the following:\r\n* Non metastatic breast carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant radio/chemotherapy \r\n*Stage II or III colorectal adenocarcinoma following appropriate surgery and adjuvant chemotherapy or following appropriate neoadjuvant chemoradiation/surgery and adjuvant chemotherapy\r\n* Stage II bladder carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant chemotherapy; patients with recurrent tumors are not eligible\r\n** Appropriate therapy for each disease must be consistent with the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology
Subject is a candidate for chemotherapy in the adjuvant setting. Adjuvant therapy must begin within days of the final surgical procedure for breast cancer.
Prior tamoxifen as adjuvant treatment is allowed as long as the patient did not have disease relapse or progression while on adjuvant tamoxifen or within weeks of last dose
Patients may have received no prior chemotherapy for stage IV disease; patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than months have elapsed between the end of adjuvant therapy and registration
Patients undergoing preoperative or adjuvant chemotherapy
Adjuvant chemotherapy more than months prior to study enrollment.
Patients must have undergone a radical cystectomy (reconstructed urinary diversion may be non-continent diversions (eg, ileal conduits) or continent non-orthotopic catheterizable diversions (eg, Indiana pouch) or continent orthotopic diversions (eg, Studer pouch or neobladder) for urothelial bladder carcinoma within days prior to registration; final cystectomy pathology must be either pure urothelial carcinoma or dominant urothelial carcinoma with admixture of other histologies excluding small cell variants\r\n* Neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy for the bladder cancer is permitted; however, all patients, even those who will receive adjuvant chemotherapy must be registered within days after completing cystectomy regardless of whether adjuvant chemotherapy has started; patients who will then receive adjuvant (postoperative) chemotherapy will be randomized within days of completing chemotherapy
Adjuvant chemotherapy if relapse occurred at least months after completion of adjuvant chemotherapy
At least weeks since last adjuvant therapy or other cancer treatment
Received prior ipilimumab therapy (Prior Adjuvant Ipilimumab and Adjuvant Interferon are permitted with a minimum week washout)
Prior -FU-based adjuvant chemotherapy less than months prior to beginning ADAPT therapy and any residual neuropathy > grade
Adjuvant chemotherapy
Less than months since prior adjuvant chemotherapy.
Adjuvant therapy < months prior to study day .
'Adjuvant therapy' will constitute a prior treatment regimen
relapsed while receiving adjuvant therapy with an AI or,
Patients must have completed a course of radiation therapy and at least adjuvant cycles of temozolomide for the phase component.
Patients may or may not have had adjuvant chemotherapy
Subjects with stage IIc-IV epithelial ovarian, fallopian tube and peritoneal cancer who have completed adjuvant treatment consisting of up to cycles of paclitaxel and carboplatin chemotherapy or other acceptable chemotherapy after initial debulking surgery with evidence of a complete or partial response by radiological imaging. These subjects may remain on hormonal therapy during the trial if such treatment has been prescribed by their treating physician. These subjects may have been in a clinical trial for an investigational carboplatin based adjuvant therapy.
A concurrent active cancer that requires non-surgical therapy (e.g., chemotherapy, radiation, adjuvant therapy). Prior history of other cancer is allowed, as long as there is no active disease within year of the first dose of PLX.
Has received previous chemotherapy for Stage IV NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least months prior to randomization)
initial definitive therapy such as surgery with or without adjuvant radiation
Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than months before entry into the study.
Patients must have completed planned local therapy (i.e., definitive surgery and radiation therapy) and adjuvant chemotherapy for breast cancer prior to registration; in addition, any prior local therapy and adjuvant chemotherapy should be completed prior to participant completion of baseline Patient Reported Outcomes (PRO) instruments (i.e., Health Assessment Questionnaire [HAQ], PROMIS Physical Function, Functional Assessment of Cancer Therapy [FACT] Breast and Endocrine Symptoms [ES], etc.) and collection of optional blood for banking for future research
Planned use of cytotoxic chemotherapy during radiation (only adjuvant temozolomide therapy will be used on this protocol)
No plan for adjuvant endometrial cancer therapy
Patients who will be receiving surgery or adjuvant chemotherapy within month following radiation treatment
) Patients on adjuvant hormone therapy for less than months.
Planned primary or adjuvant chemoradiation therapy
BRAIN CANCER: Starting adjuvant temozolomide therapy
Currently take adjuvant AI therapy
> months post local and/or adjuvant therapy
Scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by National Comprehensive Cancer Network (NCCN) guidelines (www.nccn.org); patients receiving anti-HER- therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen
Currently receiving or have plans for adjuvant radiation or chemotherapy
For patients not receiving adjuvant therapy, end of therapy will be defined as six months post diagnosis (patient)
Adjuvant treatment: laser or any surgical intervention
Has completed prior surgical management and adjuvant endometrial cancer treatment, if adjuvant treatment is indicated, prior to starting aim
Patients who have completed treatment for breast cancer and are within two years of treatment completion (primary surgery, chemotherapy or radiation therapy), whichever was received last; hormonal therapy and targeted therapies in the adjuvant setting are allowed
Prior treatment of pancreatic cancer with chemotherapy in adjuvant setting, except those where at least months have elapsed since completion of the last dose and no persistent treatment-related toxicities present
Was prescribed adjuvant therapy with an AI (prior chemotherapy or tamoxifen OK) in past to weeks (Randomized Trial only)
Have had surgery, completed treatment within the last two years, or still receiving adjuvant therapies
Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer
Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between and months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin)
In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach:\r\n* If no adjuvant therapy, register patient within days following surgery\r\n* If adjuvant chemotherapy or radiotherapy only, register patient within days following surgery\r\n* If adjuvant chemotherapy and radiation, register patient within days following surgery
Participants must not have received either chemotherapy or radiotherapy within the previous months; Note: participants receiving long-term adjuvant hormonal therapy (such as tamoxifen or aromatase inhibitors for breast cancer) are allowed
Radiotherapy must begin within weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy
Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
The patient must have completed adjuvant chemotherapy more than months ago, but no more than months prior to initial study scan
Clinical need for adjuvant chemotherapy
Received any adjuvant chemotherapy
For Adjuvant Treatment: No prior treatment with BTZ, CFZ, or IXZ
Women more than days out from primary breast surgery or adjuvant chemotherapy