Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol; however, patients receiving extended adjuvant endocrine therapy for an earlier ER positive breast cancer treated with curative intent and without recurrence for at least 5 years may continue with their endocrine therapy
Patients who already received neo/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy.
Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
Patients who have had any prior chemotherapy, or endocrine therapy for the treatment of breast cancer or any other cancer
Subjects with endocrine AE of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC
Prior neoadjuvant chemotherapy, endocrine therapy, or biologic therapy for current breast cancer [Period 2]
For Part A (LY2835219 + letrozole): Except for ongoing therapy with letrozole, the participant must not have received prior systemic endocrine therapy for metastatic disease.
For Part B (LY2835219 + anastrozole): Except for ongoing therapy with anastrozole, the participant must not have received prior systemic endocrine therapy for metastatic disease.
For Part D (LY2835219 + exemestane): The participant must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with exemestane.
ENDOCRINE RESISTANT COHORT: Pre-registration is not required for patients to be enrolled in the endocrine resistant cohort, as PIK3CA mutation status will not be assessed
ENDOCRINE RESISTANT AND ADJUVANT COHORT: Platelets >= 100,000/mcL
ENDOCRINE RESISTANT COHORT: Ki67 > 10% by central testing at Washington University AMP laboratory from a tumor biopsy performed after at least 2 weeks on neoadjuvant endocrine therapy; if Ki67 is > 10% by local testing, the Ki67 slide and H&E slide need to be reviewed by the study pathologist to confirm eligibility (discuss with study chair); for patients external to Washington University, please contact the Washington University coordinator by email so that a screening identification (ID)# can be assigned prior to shipment of the slides\r\n* Note that prior neoadjuvant endocrine therapy could include any endocrine therapy (including aromatase inhibitor, tamoxifen, fulvestrant) alone or in combination, or endocrine therapy in combination with any investigational agent that is not a Cdk 4/6 inhibitor\r\n* Patients who had a day 17 Ki67 > 10% from the NCI9170 trial are eligible for the endocrine resistant cohort\r\n* Note that enrollment to the endocrine resistant cohort will depend on the funding availability; please contact the study chair before enrolling patients to this cohort
ENDOCRINE RESISTANT COHORT: Prior treatment of this cancer including:\r\n* Surgery\r\n* Radiation therapy\r\n* Chemotherapy
No washout is required for endocrine therapy; if a patient has been on endocrine therapy within 28 days of study entry, that same endocrine therapy is permitted to be continued during protocol therapy, at the investigator’s discretion, as is continuation of ovarian suppression in premenopausal women; starting a new endocrine therapy during protocol therapy is not permitted
Prior systemic therapy:\r\n* Participant must be at least 14 days from the last dose of prior chemotherapy, endocrine therapy, biological agents (including small molecule targeted therapy) or any investigational drug product with adequate recovery of toxicity to baseline, or grade 1 (with the exception of alopecia and hot flashes) at the time of registration\r\n* There is no limit to the number of prior lines of therapy, including endocrine or cytotoxic agents; systemic treatment naive patients for metastatic disease are also eligible\r\n* Participants may initiate or continue bisphosphonate therapy on study\r\n* Continuation of ovarian suppression is allowed
Completed all adjuvant therapy including (if indicated) endocrine, trastuzumab, radiation therapy
Has received chemotherapy, immunotherapy, biologic therapy or endocrine therapy within the past 12 weeks
Has received no more than 5 previous lines of chemotherapy and has received at least one line of therapy with an endocrine therapy or endocrine therapy combination.
Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status who have completed surgery, chemotherapy, and radiation and are currently on endocrine therapy, single agent Herceptin, or observation
Prior cancer therapy (except for endocrine therapy) must have been discontinued for 1 week prior to initiation of study drugs
Patients with ER+ breast cancer must have progressed on at least 2 lines of endocrine therapy
For estrogen receptor (ER)-positive breast cancer, patients must be considered refractory to endocrine therapy, having received and progressed through at least one prior line of endocrine therapy, or are intolerant of endocrine therapy
Has received therapy for this current diagnosis of breast cancer including endocrine therapy or chemotherapy
Concurrent adjuvant endocrine therapy and bone-modifying agents is allowed
Patients must have completed at least 2 months of their current endocrine therapy prior to registration
More than two prior endocrine therapy regimens for the treatment of metastatic ER+ breast cancer
Patient must agree to the required research biopsies at baseline and after the two-week treatment with endocrine therapy in the initial part of the study (“window phase”); or at baseline and after two-week treated with endocrine therapy plus or minus palbociclib for those patients enrolled directly into the treatment phase of the study
Participants with endometrioid histology and histologically confirmed expression of estrogen receptors (ER) and/or progesterone receptors (PgR) who have not received prior endocrine therapy and for whom endocrine therapy is currently indicated.
Breast cancer treatment for the currently diagnosed breast cancer including radiation therapy, chemotherapy, targeted therapy, or endocrine therapy prior to study registration
Have received 0-2 lines of cytotoxic chemotherapy for metastatic breast cancer; prior endocrine therapy and/or targeted therapy is allowed
The subject must be deemed appropriate for neoadjuvant endocrine therapy by the referring medical oncologist
Patients must have been treated with at least one prior chemotherapy regimen in the metastatic setting or within 12 months of their last adjuvant systemic treatment and must be felt to be chemotherapy refractory; patients with ER positive disease must have demonstrated to be clinically endocrine-insensitive by progressing through at least one line of endocrine therapy, including approved combinations and considered candidate for more aggressive therapies (e.g. chemotherapy) per principal investigator (PI) or treating physician
Candidate for neoadjuvant endocrine therapy
Platelets >= 100,000/uL obtained no more than 28 days prior to the start of neoadjuvant endocrine therapy
Unwilling to undergo anti-endocrine therapy
Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease
Diagnosis of stage 0-III breast cancer within 12 years prior to enrollment; all indicated surgery, chemotherapy, and/or radiation therapy must have been completed at least 12 weeks prior to enrollment; concomitant endocrine therapy and targeted therapies such as palbociclib, pertuzumab, and trastuzumab are permitted
For HR+ breast cancer participants in part A, B, C, and F: If currently receiving endocrine therapy, a participant may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and central nervous system (CNS) disease progression has occurred while on this endocrine therapy. If these conditions are not met, participants must discontinue endocrine therapy prior to initiation of abemaciclib.
Patients receiving cytotoxic therapy (including endocrine and biological agents), radiation therapy, immunotherapy or non-topical steroids, within three (3) to four (4) weeks of enrollment.
Prior treatment with less than 4 prior endocrine therapies for metastatic breast cancer
Last dose of chemotherapy must be at least 3 weeks before first dose of study treatment; there is no required washout for endocrine therapy
Eligible for and willing to undergo a course of adjuvant endocrine therapy
No limitations to number of prior chemotherapies for metastatic disease; treatment with prior taxanes (except nab-paclitaxel) is allowed as long as it has been 6 months or more since exposure to prior taxane; NOTE: For subjects who are, or who have previously received endocrine therapy for breast cancer, the treating investigator will decide how many days should pass between the last dose of endocrine therapy and the first dose of study treatment
Subjects should be > 2 weeks from prior systemic chemotherapy for breast cancer AND should have recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy prior to study entry; NOTE: For subjects who are, or who have previously received endocrine therapy for breast cancer, the treating investigator will decide how many days should pass between the last dose of endocrine therapy and the first dose of study treatment
Treatment including radiation therapy (RT), chemotherapy, targeted therapy, or endocrine therapy for the currently diagnosed breast cancer prior to randomization
Patients must have had progressive disease after at least one line of endocrine therapy for metastatic disease (includes relapse while receiving endocrine therapy); there should be at least 1 week interval between the last endocrine treatment for an aromatase inhibitor and at least 2 weeks for tamoxifen or fulvestrant
Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration
Step 2 Registration must take place within 84 days after definitive surgery; patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to randomization
There is no upper limit on prior chemotherapy, targeted therapy, or endocrine therapy
relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently; progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease;
Phase I (Cohorts J through S): Post-menopausal females with HER2-negative, hormone-receptor positive breast cancer that has progressed or failed to response to at least one prior endocrine therapy in the adjuvant or metastatic setting
Oral endocrine therapy </= 2 weeks before study treatment
Patient must have been previously treated with an aromatase inhibitor (either letrozole, anastrozole or exemestane) either in the adjuvant or metastatic setting, and have one of the following types of primary or secondary endocrine resistant disease\r\n* Primary clinical resistance is defined as one of the following:\r\n** Recurrence within the first 2 years of adjuvant endocrine therapy while on aromatase inhibitor therapy\r\n** Progression within first 6 months of initiating first-line endocrine therapy (either aromatase inhibitor or fulvestrant containing regimen) for the treatment of metastatic breast cancer \r\n* Secondary clinical resistance is defined as one of the following:\r\n** Recurrence after year 2 while receiving adjuvant aromatase inhibitor therapy, or within 12 months of completing adjuvant aromatase inhibitor therapy\r\n** Progression occurring 6 or more months after initiating the first endocrine therapy for metastatic disease (either fulvestrant or aromatase inhibitor containing regimen)
Previous adjuvant endocrine therapy for initial breast cancer was allowed but had to be discontinued at least 1 week before receiving the study drug
relapsed with documented evidence of relapse more than 12 months from completion of adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) for advanced/metastatic disease
Part A, B, C: Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy
Part D: Patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. Patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. Patients must have received prior treatment with a CDK4/6 inhibitor
Any other anti-cancer endocrine therapy less than 14 days before first dose of study treatment
No treatment for current primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, immunotherapy, investigational therapy or surgery; previous treatment for breast and/or ovarian cancer with chemotherapy, endocrine therapy, surgery and radiation are allowed if >= 3 years prior to current diagnosis and there is no clinical evidence of metastatic disease
Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
Uncontrolled endocrine disorder. Patients who are on endocrine replacement therapy must be on a stable dose.
Relapsed or progressed following endocrine therapy.
Participants for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
Endocrine resistant breast cancer, defined as either:\r\n* Relapsed while on adjuvant endocrine therapy or within 1 year of completion of adjuvant endocrine therapy or\r\n* Progression through at least one line of endocrine therapy for metastatic or locally advanced breast cancer; there is no limit on the number of prior endocrine therapies received
Prior endocrine therapy for breast cancer.
relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
Participants must have demonstrated ability to tolerate adjuvant endocrine therapy, either tamoxifen or aromatase inhibitor (AI), by prior successful completion of at least 1 month of endocrine therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on endocrine therapy for at least a projected 2 year continuous duration; ongoing use of any AI, including letrozole, anastrozole, or exemestane, or tamoxifen is allowed; concurrent gonadotropin-releasing hormone (GNRH) agonist is allowable as well; patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapy
ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
Patients on bisphosphonates and/or endocrine therapy are eligible
Patients must have been diagnosed with the current breast cancer >= 3 and =< 60 months from planned baseline visit date; in addition, participants must have completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy within >= 3 months prior to registration; NOTE: concurrent anti-human epidermal growth factor receptor 2 (HER2) therapy is permitted; concurrent endocrine breast cancer therapy is permitted; patients may enroll >= 3 months after initiation of hormone therapy and if expected to continue the same endocrine/hormone agent for the duration of the study (i.e., care should be taken to ensure a participant enrolling near 5 years since time of hormone treatment initiation will continue the same agent for at least 12 months, switching hormone therapy on study should be avoided); concurrent enrollment in other interventional or drug clinical trials is at the discretion of the protocol chair
Any number of prior endocrine therapies (including tamoxifen, fulvestrant and/or aromatase inhibitors in either the adjuvant or metastatic setting) and any number of prior chemotherapy regiments; anti-cancer systemic therapy, such as chemotherapy or biologics or endocrine therapy, other than the AI, must be discontinued for >= 3 weeks prior to starting study treatment
No limit on prior lines of endocrine therapy or biologic therapy; endocrine therapy and biologic therapy must be discontinued at least 7 days prior to initiation of protocol therapy
Breast cancer patients must be at least 3 months post-active treatment (including chemotherapy, radiation therapy, endocrine therapy, and/or maintenance therapy), but not greater than 5 years post-active treatment (exception: aromatase inhibitors (AIs) are required, and monoclonal antibodies are allowed)
Endocrine resistant breast cancer, defined as either:\r\n* Relapsed while on adjuvant endocrine therapy or within 1 year of completion of adjuvant endocrine therapy or\r\n* Progression through at least one line of endocrine therapy for metastatic or locally advanced breast cancer; there is no limit on the number of prior endocrine therapies received
Receiving concurrent endocrine, cytotoxic, or biologic agent(s) or within time limits specified above prior to study day 1
If the participant is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 12 weeks of adjuvant endocrine therapy following his/her last non-endocrine therapy (surgery, chemotherapy, or radiation).
Subjects must be receiving or be scheduled to receive standard of care systemic adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy
Prior endocrine therapy for any histologically-confirmed cancer is not allowed; prior endocrine therapy that was administered >= 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed
There is no limit to the number of prior chemotherapy or endocrine therapy regimens allowed; patients with ER(+) AR(+) breast cancer must have had at least 1 prior line of endocrine therapy to be eligible for the phase I portion of the trial
Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.
Patients with metastatic disease currently on endocrine therapy must be willing to stop endocrine therapy for 2 weeks prior to starting the study and to switch to a new endocrine therapy on the study (at week 4)
Can be on other endocrine therapy if willing to change a different endocrine therapy agent for the trial
Must have at least one FDA approved endocrine therapy option with which the patient has not received prior treatment
Patients must have had endocrine therapy initiated or planned for >= 5 years; endocrine therapy can be given concurrently or following RT
Patients treated with neoadjuvant chemo or endocrine therapy for breast cancer
Participants with HR+/HER2- breast cancer for whom endocrine-based therapy is considered an appropriate option per local clinical guidelines (i.e. participants should not be considered eligible for endocrine-based treatment)
Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
Progression on or after endocrine treatment
Prior treatment with other chemotherapeutic agents, trastuzumab, endocrine and radiation therapy is permitted;
Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy)
Has received adjuvant endocrine therapy (selective estrogen receptor modulator [SERM] alone, gonadotropin-releasing hormone [GnRH] analogue plus SERM or aromatase inhibitors [AI]) for >= 18 months but =< 30 months for early breast cancer\r\n* Note: patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible
The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment
Completion of all primary therapy (with the exception of ongoing endocrine or trastuzumab therapy), including surgery, radiation, and/or chemotherapy greater than 4 weeks prior to study enrollment
Have completed all surgery, radiation, and/or chemotherapy treatments at least 6 months previously; may still be receiving trastuzumab or endocrine adjuvant therapy
May use adjuvant endocrine therapy if use will be continued for duration of study intervention
Stage I-III breast cancer\r\n* Treatment status: At least 6 months and no more than 5 years after the conclusion of active breast cancer therapy, including surgery, radiation therapy and (neo)adjuvant chemotherapy, if administered\r\n*NOTE: Adjuvant HER2-targeted therapy and endocrine therapy may still be ongoing at the time of study enrollment; those on endocrine therapy must have been on their current endocrine regimen for at least four weeks prior to study enrollment and must not have plans to change endocrine regimens during the study period
Concurrent endocrine therapy permissible
Breast cancer survivors treated with chemotherapy with no evidence of disease with treatment completed at least six months prior to study participation with or without current endocrine therapy
Women who are receiving endocrine therapy at the time of recruitment are eligible for the study
Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years\r\nago (current use of endocrine therapy is acceptable)
No previous chemotherapy, endocrine, therapy or radiation therapy with therapeutic intent for this cancer
Progression through at least one prior line of endocrine therapy
Participant is scheduled to initiate treatment with everolimus combined with exemestane or another form of endocrine therapy
Patients receiving systemic chemotherapy or radiation therapy within 4 weeks of the start of everolimus (Note: there is no wash-out period for endocrine therapy)
Concomitant trastuzumab and anti-endocrine therapies are permitted; if taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment
Participants who have received endocrine therapy within 1 year prior to screening breast MRI
>= 6 months from all previous breast cancer treatment (including endocrine therapy)
COHORT A2: Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or surgery at least 3 months prior to study entry; may continue to take endocrine therapy and/or maintenance trastuzumab
At least 3 months after completion of any cytotoxic chemotherapy or radiation or surgery; may continue to take endocrine therapy and/or maintenance trastuzumab
May use adjuvant endocrine therapy if use will be continued for duration of study period
Subjects with prior breast cancer must be off all systemic therapy (including endocrine agents) for at least 2 years prior to registration
Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.
Patients may enroll within 10 years of breast cancer diagnosis, as long as there is a plan for at least 1 more year of adjuvant endocrine therapy
>= 6 months from all previous breast cancer treatment (including surgery for invasive cancer, chest wall radiotherapy, chemotherapy, trastuzumab and endocrine therapy)
DISEASE CHARACTERISTICS:\n\n          -  Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the\n             following criteria:\n\n               -  Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone\n                  receptor), determined by immunohistochemistry, after primary surgery and before\n                  commencement of prior endocrine therapy\n\n               -  Prior local treatment including surgery with or without radiotherapy for primary\n                  breast cancer with no known clinical residual loco-regional disease\n\n               -  Following primary surgery, eligible patients must have had evidence of lymph node\n                  involvement either in the axillary or internal mammary nodes, but not\n                  supraclavicular nodes\n\n               -  Clinically disease-free\n\n          -  Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators\n             (SERMs), aromatase inhibitors (AIs), or a sequential combination of both\n\n               -  When calculating 4-6 years, neoadjuvant endocrine therapy should not be included\n\n          -  No evidence of recurrent disease or distant metastatic disease\n\n          -  No prior bilateral breast cancer\n\n        PATIENT CHARACTERISTICS:\n\n          -  Female\n\n          -  Must be postmenopausal by any of the following criteria:\n\n               -  Patients of any age who have had a bilateral oophorectomy (including radiation\n                  castration AND amenorrheic for > 3 months)\n\n               -  Patients 56 years old or older with any evidence of ovarian function must have\n                  biochemical evidence of definite postmenopausal status (defined as estradiol,\n                  luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the\n                  postmenopausal range)\n\n               -  Patients 55 years old or younger must have biochemical evidence of definite\n                  postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal\n                  range)\n\n                    -  Patients who have received prior luteinizing-hormone releasing-hormone\n                       (LHRH) analogues within the last year are eligible if they have definite\n                       evidence of postmenopausal status as defined above\n\n          -  Clinically adequate hepatic function\n\n          -  No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy\n\n          -  No prior or current malignancy except adequately treated basal cell or squamous cell\n             carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or\n             ipsilateral in situ breast carcinoma\n\n          -  No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would\n             prevent prolonged follow-up\n\n          -  No psychiatric, addictive, or any other disorder that compromises compliance with\n             protocol requirements\n\n        PRIOR CONCURRENT THERAPY:\n\n          -  See Disease Characteristics\n\n          -  More than 12 months since prior and no other concurrent endocrine SERM/AI therapy\n\n          -  Any type of prior adjuvant therapy allowed including, but not limited to, any of the\n             following:\n\n               -  Neoadjuvant chemotherapy\n\n               -  Neoadjuvant endocrine therapy\n\n               -  Adjuvant chemotherapy\n\n               -  Trastuzumab (Herceptin®)\n\n               -  Ovarian ablation\n\n               -  Gonadotropin releasing hormone analogues\n\n               -  Lapatinib ditosylate\n\n          -  No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of\n             bone loss), or any other investigational agent
Patient must NOT be planning to receive molecular targeted therapy (such as everolimus or palbociclib) nor HER2 directed therapy in addition to endocrine therapy
Patient must NOT have received prior endocrine therapy for metastatic disease (i.e., must be first-line endocrine therapy for metastatic disease)
Patient is not now, and never has received adjuvant endocrine therapy OR patient is currently receiving or has received adjuvant endocrine therapy in the past, AND adjuvant endocrine therapy was initiated > 2 years prior to diagnosis of metastatic disease\r\n* Note: patients who developed metastatic disease while still receiving adjuvant endocrine therapy must have a planned change in the type of endocrine agent used for subsequent metastatic disease treatment; patient is not receiving blocking adjuvant therapy (such as toremifene or tamoxifen) OR patient is receiving blocking adjuvant therapy, but will stop this therapy a minimum of 60 days prior to FES-PET/CT while still complying with the study timeline
Patients planning to receive neoadjuvant chemotherapy/endocrine therapy after the clinical breast MRI and before the research breast PET/MRI examination, those currently undergoing neoadjuvant chemotherapy/endocrine therapy, or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI
No prior endocrine therapy for metastatic disease is allowed (i.e. must be first-line endocrine therapy for metastatic disease). However, a history of adjuvant endocrine therapy is allowed, as long as the date of diagnosis of metastatic disease is > 2 years following initiation of adjuvant endocrine therapy. Patients who develop metastatic disease while still receiving adjuvant endocrine therapy must have a change in the type of endocrine agent used for subsequent metastatic disease treatment. Patients on blocking adjuvant therapy (with a blocking agent such as toremifene or tamoxifen) must be off the agents for a minimum of 60 days to allow for adequate uptake of FES.
Prior or chemotherapy or endocrine therapy is permitted
History of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening
Patients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed)
Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist; selected treatments may be part of experimental treatment protocols for which the patient would be separately consented
Patients undergoing neoadjuvant endocrine therapy
Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer.
Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exceptions of octreotide long-acting release (LAR) (for neuroendocrine tumors) and endocrine therapy (for prostate, breast, or gynecologic malignancies)