Known estrogen, progesterone, and HER status of either primary tumor or metastasis; \r\n* Note: estrogen, progesterone and HER status of metastasis preferred for stratification
Participants with histologically or cytologically confirmed hormone receptor (HR)-positive, Her-negative metastatic breast cancer; central confirmation of HR positivity is not required
Primary and/or metastatic breast tumor must be negative for over-expression of estrogen and progesterone receptors; patients with weak estrogen receptor and/or progesterone receptor expression (< % on immunohistochemistry [IHC]) will be eligible
Estrogen receptor positive, progesterone receptor positive, HER negative
Breast carcinoma that is estrogen receptor, progesterone receptor, and Her negative (triple-negative breast cancer; TNBC);
Women who have received treatment with Selective Estrogen Receptor Modulators (SERMs) (e.g. tamoxifen, raloxifen) or aromatase inhibitors
Biopsy proven neuroendocrine tumor, which is somatostatin receptor positive as demonstrated on somatostatin receptor PET\r\n* All sites or origin are eligible\r\n* Functional and nonfunctional tumors are allowed
Previous or concurrent treatment with selective estrogen receptor modulator (SERM) and/or hormonal replacement therapy within  months of the study
PART I: Stable, concurrent use of tamoxifen or aromatase inhibitors for hormone receptor positive breast cancer
PART II: Stable, concurrent use of tamoxifen or aromatase inhibitors for hormone receptor positive breast cancer are allowed
Patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for prevention or treatment of breast cancer or for other indications (e.g., osteoporosis, prior ductal carcinoma in situ [DCIS]), or who receive aromatase inhibitors for prevention or treatment of breast cancer, are eligible; patients who are hormone-receptor positive and who have received other hormonal agents for the treatment of breast cancer (e.g., Fulvestrant) are also eligible; tamoxifen therapy or other hormonal agents should be discontinued at least  week before the patient is enrolled on this study
Oral estrogen, progesterone, testosterone therapy within last  months
Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYPA inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens; concurrent anti-HER therapy and other targeted therapy (e.g., CDK/ inhibitor, mTOR inhibitor) is permitted; must have started the current regimen at least  weeks prior to enrollment
COHORT : HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients must have measurable disease, per RECIST .
COHORT : HORMONE RECEPTOR POSITIVE BREAST CANCER: HR+BC patients must have received prior treatment with at least  lines of hormonal treatment (selective estrogen receptor modulator [SERM], adriamycin-ifosfamide [AI], or fulvestrant) and deemed ineligible for further hormonal therapy; patients may have received prior chemotherapy and there is no limit to the number of prior chemotherapy
COHORT : HORMONE RECEPTOR POSITIVE BREAST CANCER: Absolute neutrophil (ANC) >= ,/mm^ (>= . X^/L)
COHORT : HORMONE RECEPTOR POSITIVE BREAST CANCER: Platelet count >= ,/mm^ (>=  X ^/L)
COHORT : HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients who have undergone radiotherapy within  weeks of first dose of study treatment
Any receptor status (estrogen receptor, progesterone receptor, HER receptor); patients who are hormone receptor (HR)+ should also no longer be candidates for hormonal-based therapy; patients who are HER+ should have progressed on or no longer be candidates for available HER directed therapy; hormonal therapy must be stopped prior to day  of treatment
COHORT  (HORMONE RECEPTOR POSITIVE [HR+])
DISEASE SPECIFIC EXPANSION COHORTS: Breast cancers patients enrolled on this study must have:\r\n* Metastatic or advanced (incurable and unresectable) HER negative breast cancer regardless of estrogen receptor status (both hormone receptor positive and triple negative patients are eligible)\r\n* Received hormonal therapy, as appropriate based on their hormone receptor status; hormone receptor positive patients who have not received endocrine therapy for recurrent/metastatic disease are eligible, permitted their physician feels they are not appropriate for first line endocrine therapy, for example for high risk visceral metastatic disease
Tumor is hormone receptor (HR)+ (estrogen receptor and/or progesterone receptor positive with at least % expression of either receptor by local immunohistochemical staining) and HER negative based on local assessment
FOR ALL PHASES (Ib AND II): Current therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (SERM), either for osteoporosis or prevention of breast cancer; subjects must have discontinued therapies for at least  days prior to first baseline biopsy
Patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for the prevention or treatment of breast cancer or for other indications (e.g., osteoporosis, prior ductal carcinoma in situ [DCIS]), or who receive aromatase inhibitors for prevention or treatment of breast cancer, are eligible; patients who are hormone-receptor positive and who have received other hormonal agents for the treatment of breast cancer (e.g., Fulvestrant) are also eligible; tamoxifen therapy or other hormonal agents should be discontinued at least  week before the patient is started on study therapy
Patients can have hormone receptor (HR)+ or HR-negative disease
Prior selective estrogen receptor downregulator use (SERD), including fulvestrant
Locally advanced breast cancer defined as any of the following per American Joint Committee on Cancer (AJCC) staging criteria:\r\nNote: imaging methods that may be used for tumor measurement to determine eligibility include breast ultrasound and breast magnetic resonance imaging (MRI); mammography may not be used\r\n* T based on tumor measurements by physical examination or imaging with clinically positive regional lymph nodes (cN or cN), irrespective of hormone receptor status\r\n* Hormone receptor-negative patients with tumor size of - cm measured by physical examination or imaging with clinically negative regional lymph nodes (cN)\r\n* Any T based on tumor measurements by physical examination or imaging, irrespective of hormone receptor status\r\n* Any T (including inflammatory breast cancer), irrespective of hormone receptor status
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
Concurrent standard long-term anticancer hormonal therapy with drugs including, but not limited to, selective estrogen receptor modulators or Gonadotropin-releasing hormone (GnRH) analogs if started at least six months before the first dose of ARQ  is allowed
Minimum number of prior treatments required given standard nab-paclitaxel dosing:\r\n* If HER negative: none; Note: Subjects with hormone-receptor positive tumors (estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]) must have failed available appropriate lines of hormonal therapy (eg, ovarian suppression or ablation, selective estrogen receptor modulators, aromatase inhibitors, estrogen receptor antagonists, etc), unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate\r\n* If HER positive: two prior regimens containing HER targeted therapies in the inoperable locally advanced and/or metastatic setting; prior therapy for inoperable locally advanced/metastatic disease should include trastuzumab plus pertuzumab as well as ado-trastuzumab; pertuzumab and ado-trastuzumab must have been previously used, unless for reasons that include, but are not limited, to the following: intolerance to pertuzumab and/or ado-trastuzumab, medical contraindication, regimen declined by patient, treating investigator discretion, or medical insurance coverage issues which prevented administration of pertuzumab or ado-trastuzumab; these reasons must be reviewed with the study chairs and documented in the medical record and care report form; patients who relapse within  months of completing neoadjuvant/adjuvant pertuzumab or ado-trastuzumab would be considered as having progressed on that regimen\r\n* There is no maximum number of prior treatments allowed in the metastatic setting
Estrogen Receptor-positive pathology
Current use of selective estrogen receptor modulators (SERMS) or aromatase inhibitors
Clinically node negative, hormone receptor positive (+). HER negative (-), with <% intraductal component in the aggregate.
Patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for prevention or for other indications (e.g., osteoporosis, prior ductal carcinoma in situ [DCIS]) are eligible; tamoxifen therapy or other SERMs should be discontinued at least  week before the patient is enrolled on this study
Estrogen and/or progesterone receptor positive
HER-negative and hormone receptor-positive status (common breast cancer classification tests)
Have brain metastases secondary to hormone receptor positive breast cancer, NSCLC, or melanoma.
Has documented hormone (estrogen and/or progesterone) receptor (HR)-positive disease
Taken tamoxifen or other selective estrogen/progesterone receptor modulators (SERMs/SPRMs) within two years prior to entering study or been required to discontinue SERM therapy due to thromboembolic or uterine toxicity
Willing to accept oral endocrine therapy with a third generation aromatase inhibitor (AI) or selective estrogen receptor modifier (SERM)
Subject has hormone-receptor positive metastatic breast cancer with disease progression following antiestrogen therapy
Estrogen receptor positive tumor and/or progesterone receptor positive tumor
Estrogen receptor negative and progesterone receptor negative tumor
Previous endocrine therapy such as raloxifene or tamoxifen (or other selective estrogen receptor modulator [SERM]) or an aromatase inhibitor for any malignancy
DCIS must express estrogen and/or progesterone receptor, as determined by immunohistochemical methods on the diagnostic pathology sample, according to the local institutions standard protocol; greater than or equal to % cells will be considered to be positive
Patients must not have received an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) such as tamoxifen or raloxifene within  years prior to registration
Estrogen receptor-positive and/or progesterone receptor-positive, HER-negative breast cancer
Patients with advanced or metastatic breast cancer must have disease that is HER-negative, estrogen receptor-negative, and progesterone receptor-negative (ie, TNBC). Patients with advanced or metastatic disease may have up to  lines of cytotoxic therapy. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory and has HER negative breast cancer
Subject has received zero to one prior cytotoxic chemotherapy regimen for metastatic disease, regardless of prior targeted therapy (eg. everolimus, palbociclib or lapatinib), biologic (eg. trastuzumab) or hormonal therapy treatment (eg. aromatase inhibitors, selective estrogen receptor modulators, or estrogen receptor down-regulators).
A clinical-pathologic stage - estrogen/grade (CPS-EG) score of ?, or score  if nodal status at surgery is ypN+, calculated using local estrogen receptor status and grade assessed on either core biopsies taken before start of neoadjuvant treatment or surgical specimen (see chapter .).
Part , Cohort : Histologically and/or cytologically confirmed diagnosis of breast cancer with hormone receptor-positive status (ER and/or PgR positive) and HER-negative status with prior exposure to tamoxifen and/or an aromatase inhibitor and/or an aromatase inhibitor plus palbociclib. Prior treatment with tamoxifen in the neoadjuvant setting is allowed but must have been discontinued for at least  year prior to the first dose.
Estrogen receptor positive disease is defined as > % nuclear staining
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER-negative breast cancer.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
Known hormone receptor status of the primary tumor
Known hormone receptor status (estrogen receptor and progesterone receptor)
Estrogen receptor and/or progesterone receptor positive disease
No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past  years
Estrogen and/or progesterone receptor positive breast cancer (> % staining), as determined by pathology from either primary or metastatic site(s); central confirmation is not required
Subject has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory (based on most recently analyzed biopsy).
Histologic proof of metastatic or locally advanced, unresectable breast cancer which is estrogen receptor positive and/or progesterone positive per institutional standards
Centrally determined HER-positive, hormone receptor status, breast molecular subtype by Prediction Analysis of Microarray  (PAM) on the pre-treatment biopsy of metastatic lesion obtained during screening
Postmenopausal, Hormone receptor positive (HR+), HER negative breast cancer
Metastatic breast cancer patients who are hormone receptor positive at baseline must be hormone refractory or have indications for emergent treatment with chemotherapy (e.g., visceral crisis)
History of breast cancer, endometrial cancer or ovarian cancer or taking aromatase inhibitors or selective estrogen receptor modulators
Known hormone receptor status of the primary tumor
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
Patients with hormone receptor +/- and HER +/- breast cancer are eligible
Known hormone-receptor status
Estrogen and/or progesterone receptor positive breast cancer, as determined by pathology from either primary or metastatic site(s); central confirmation is not required
Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positive
Part G: Breast Cancer that is not only advanced and/or metastatic but also hormone receptor positive
Must have estrogen and/or progesterone receptor positive histologically confirmed adenocarcinoma of the breast; receptor status may be based on any time during treatment prior to study registration, and from any site (i.e. primary recurrent, or metastatic)
For invasive cancers, the tumor must be estrogen receptor positive (defined as % or greater expression of estrogen receptor)
Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
Unknown hormone-receptor status
Hormone receptor status\r\n* Estrogen or progesterone receptor positive or\r\n* Estrogen and progesterone receptor negative and clinical tumor size =< . cm
Estrogen receptor and progesterone receptor negative tumor with clinical size >  cm
Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER-negative breast cancer
Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing
Inoperable estrogen receptor positive and HER negative breast cancer.
Subjects with a primary tumor that is hormone (estrogen, progesterone, or both) receptor-positive or receptor-negative are eligible.
Group : Post-menopausal women with advanced stage estrogen receptor positive breast cancer who are candidates for exemestane or fulvestrant
Patients with estrogen receptor positive (ER+) breast cancer being treated with hormonal therapy (selective estrogen receptor modulator or aromatase inhibitor) who have rising tumor markers as evidence of disease progression or metastatic disease on scans may continue on hormonal therapy while being treated with vaccine
Patients must have histologically or cytologically diagnosed locally advanced or metastatic triple-negative breast cancer defined as negative for estrogen receptor, progesterone receptor and HER.
HER negative disease, and a known positive hormone receptor status (common breast cancer classification tests)
Patients with hormone receptor-positive disease must have progressed on or following hormone therapy
For phase I patients only: Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators
Estrogen receptor-positive and/or progesterone receptor-positive, HER-negative breast cancer
Patients must have estrogen and/or progesterone receptor positive histologically confirmed stage I-III adenocarcinoma of the breast
PHASE I: Hormone receptor positive tumor defined as any positivity of estrogen or progesterone receptor
PHASE II: Hormone receptor positive tumor defined as any positivity of estrogen or progesterone receptor
Prior use of selective estrogen receptor modulator (SERMS) and aromatase inhibitors (AIs) including tamoxifen, raloxifene, anastrozole, letrozole, or exemestane for prevention or therapy within  years
No prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
Low grade disease positive for estrogen and progesterone receptors
Patients with a known hypersensitivity reaction to -HT receptor antagonists or NK receptor antagonists
Any receptor status
Hormone receptor status not specified
Breast cancer (stage , I, II, III),  months to  years post oncologic therapies of surgery, chemotherapy, and/or radiation therapy (does not exclude current selective estrogen receptor modulators or aromatase inhibitors)
Must be more than six months from ingestion of antihormonal therapy (tamoxifen, raloxifene, other selective estrogen receptor modulators [SERMs], aromatase inhibitors)
Use of any chemopreventive agents (selective estrogen receptor modulators [SERM]) in the last  months
Prior use of selective estrogen receptor modulators (SERMS) and aromatase inhibitors (AIs) for prevention or therapy, except for a maximum of  months and at least  months prior
Current use or <  months since use of selective estrogen receptor modulator (SERMS) or aromatase inhibitors or any other investigational treatment for breast cancer prevention or therapy
Use of any selective estrogen receptor modulator or aromatase inhibitor within  months of randomization, including, but not limited to: tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole
Prior diagnosis of stage  to III breast cancer that is estrogen receptor negative, progesterone receptor negative with completion of definitive surgery, radiation therapy and/or chemotherapy
Use of endocrine therapy (selective estrogen receptor modulator, aromatase inhibitor, gonadotrophin releasing hormone [GnRH] agonist) within  months of start of study
Taken tamoxifen or other selective estrogen/progesterone receptor modulators (selective estrogen receptor modulators[SERMs]/selective progesterone receptor modulators [SPRMs]) within two years prior to entering study or been required to discontinue SERM therapy due to thromboembolic or uterine toxicity
Use of any selective estrogen receptor modulator or aromatase inhibitor (tamoxifen, raloxifene, arzoxifene, acolbifine, anastrozole, exemestane, letrozole) within the previous  months
Postmenopausal, Estrogen-receptor positive and/or Progesterone-receptor positive breast cancer
Participants may have a personal history of non-ovarian malignancy, but must be without evidence of disease at enrollment and the patient must have completed treatment (including surgery, chemotherapy, or radiotherapy) >  months prior to enrollment (other than non-melanoma skin cancer); current or past selective estrogen receptor modulator (SERM) or aromatase inhibitor use is allowed
Use of selective estrogen receptor modulators (SERMS) in the past  months, including tamoxifen and raloxifene
Estrogen receptor- or progesterone receptor-negative disease
Estrogen receptor positive breast cancer
Diagnosed with hormone receptor-positive breast cancer and prescribed endocrine hormonal treatment (EHT)