Documented history of prior tamoxifen, aromatase inhibitor, or raloxifene in last 6 months
1-2 prior regimens (including primary therapy); hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit
Patients who have had hormonal therapy (e.g., tamoxifen, aromatase inhibitor) within 1 week prior to entering the study
Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug.
Participants who are receiving other concurrent chemotherapies or immunotherapies for their cancer (except for patients who will receive letrozole, anastrozole, exemestane, tamoxifen, fulvestrant, trastuzumab, bisphosphonates, or ovarian suppression therapy)
Patients must not have received any prior chemotherapy, radiation therapy, or endocrine therapy for their current breast cancer; patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least one month prior to baseline study biopsy
For Part C (LY2835219 + tamoxifen): The participant may have received prior systemic endocrine therapy for metastatic disease and may be receiving ongoing therapy with tamoxifen.
Use hormone replacement therapy (including systemic or topical estrogen, progesterone, or testosterone based medication) or/and phytoestrogen supplements (i.e. black cohosh) or has been on progestin (including progestin containing IUD), tamoxifen or aromatase inhibitor within the prior 3 months
Women who have received treatment with Selective Estrogen Receptor Modulators (SERMs) (e.g. tamoxifen, raloxifen) or aromatase inhibitors
Have never used tamoxifen, raloxifene, or other antiestrogen compounds
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 1 week before the patient is enrolled on this study
Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYP17A1 inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens; concurrent anti-HER2 therapy and other targeted therapy (e.g., CDK4/6 inhibitor, mTOR inhibitor) is permitted; must have started the current regimen at least 4 weeks prior to enrollment
HER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy (e.g. aromatase inhibitor, tamoxifen or fulvestrant) and previously treated with at least 2 chemotherapy containing regimens.
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 28 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 1 week before the patient is started on study therapy
Patients are not eligible if they have previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy; this includes use for prophylactic reasons, including treatment of osteoporosis or cancer prevention with tamoxifen, raloxifene, or aromatase inhibitors (AI)
Prior treatment or preventative use of any hormonal agent such as aromatase inhibitors (AI), fulvestrant, raloxifene, tamoxifen or other SERM, or with any other hormonal agent used for the treatment or prevention of BC or for any other indication (e.g. osteoporosis).
Patients with a history of tamoxifen and/or aromatase inhibitor use for treatment or prevention are eligible but should discontinue these medications at least 2 weeks prior to starting this trial
Any prior treatment with radiation therapy or chemotherapy for the currently diagnosed breast cancer prior to registration; endocrine therapy may be given but not within 28 days prior to study entry and must be stopped if the patient will be receiving chemotherapy until completion of chemotherapy; patients must discontinue any hormonal agents such as raloxifene, tamoxifen, or other selective estrogen receptor modulators prior to registration
For subjects enrolled in the Anastrozole Arm, prior hormonal therapy (including, but not limited to, tamoxifen, megestrol acetate, fulvestrant, and GnRH analogs) for the treatment of recurrent/advanced endometrial cancer are not allowed
Current use of selective estrogen receptor modulators (SERMS) or aromatase inhibitors
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 1 week before the patient is enrolled on this study
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)
Current use of tamoxifen, aromatase inhibitors, or SERMs for a breast cancer indication for at last six months
Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy; patient who have received tamoxifen or raloxifene for purposes of chemoprevention (e.g. breast cancer prevention trial or for other past indications (including previous breast cancer) are eligible; tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled on this study
Women may have been taking tamoxifen or raloxifene as a preventive agent prior to study entry but must have discontinued the drug for at least 21 days prior to study enrollment
1 week for non-cytotoxic agents, such as interferon, tamoxifen, & cis-retinoic acid
Previous endocrine therapy such as raloxifene or tamoxifen (or other selective estrogen receptor modulator [SERM]) or an aromatase inhibitor for any malignancy
Any patients with a history of tamoxifen or raloxifene use within two years of current DCIS diagnosis are not eligible
Tamoxifen or other preventive measures within 6 months
Patients must not have received an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) such as tamoxifen or raloxifene within 5 years prior to registration
Prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within last 2 years
Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab) are allowed and are not counted towards the prior line of therapy.
Major surgery within <30 days of starting treatment or received chemotherapy, investigational agents, or other cancer therapy, except hormonal therapy (eg, tamoxifen, aromatase inhibitors), <14 days prior to the initiation of investigational products
? 14 days elapsed from administration of any non-cytotoxic agent (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid)
Part 2, Cohort 3: Histologically and/or cytologically confirmed diagnosis of breast cancer with hormone receptor-positive status (ER and/or PgR positive) and HER2-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 1 year prior to the first dose.
Concurrent treatment with hormone replacement therapy is permitted at the discretion of the treating physician; patients who have been taking hormonal/hormone blocking agents for breast cancer or breast cancer prevention or other indication are eligible; use of anti-hormonal agents (tamoxifen, medroxyprogesterone, aromatase inhibitors) is permitted at the discretion of the treating physician; documentation of concurrent medications is required
At least 2 months must have elapsed from the use of tamoxifen
Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.
Tamoxifen therapy less than 14 days before first dose of study treatment
Disease that progressed during treatment or within 12 months of completion of adjuvant therapy with tamoxifen and/or an aromatase inhibitor (AI).
No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years
Hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will not count towards line limit considerations
Minimum of 6 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery and no evidence of recurrent disease; minimum of 6 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 6 months
Receiving hormone replacement therapy, tamoxifen, or raloxifene within 6 months of trial entry; patients on non-systemic hormone replacement therapy are eligible
Breast cancer patients must be currently on adjuvant aromatase inhibitors
Current therapy with endocrine agents (tamoxifen, raloxifene, toremifene and all aromatase inhibitors) and/or bisphosphonates and/or tumor necrosis factor (ligand) superfamily, member 11 (RANK)-ligand inhibitors is permitted
Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573
Patients who have received agents that modulate or downregulate the estrogen receptor for breast cancer prevention (e.g. tamoxifen, raloxifene, fulvestrant) or bone health (raloxifene) are eligible if they were on treatment for at least 6 months, did not have a diagnosis of breast cancer on the medication, and have discontinued the agents 6 months prior to study registration
Prior aromatase inhibitors (e.g. anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant setting
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 4 weeks of last dose
The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).
Women currently on tamoxifen and raloxefene for prevention are not eligible
1 week for non-cytotoxic agents (e.g., interferon, tamoxifen, & cis-retinoic acid)
Patient has been treated with all FDA approved endocrine therapies or has been treated with all FDA approved endocrine therapies except for tamoxifen (tamoxifen is excluded from the trial)
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
Prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within last 2 years
Patients must not have received prior AI therapy with exemestane, letrozole, or anastrozole as preoperative/adjuvant therapy or for prevention of breast cancer; prior tamoxifen is allowed
For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but not current tamoxifen. Prior tamoxifen is permitted with a 30 day wash out period)
Prior use of selective estrogen receptor modulator (SERMS) and aromatase inhibitors (AIs) including tamoxifen, raloxifene, anastrozole, letrozole, or exemestane for prevention or therapy within 5 years
7 days from administration of non-cytotoxic agents [e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)]
No prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the Food and Drug Administration (FDA)-approved AIs (anastrozole, exemestane, letrozole)
Prior tamoxifen use is allowed
Participants must self-identify as being at least 90 days post final chemotherapy, biologic therapy, or radiation therapy treatment and/or breast surgery; current use of hormonal therapy is permitted (e.g., tamoxifen and aromatase inhibitors)
Women who have been diagnosed with stage I-IIIA breast cancer will be recruited 1-8 years after the completion of all primary cancer treatment except for longer-term hormonal therapies (tamoxifen, aromatase inhibitors); recruit women who have received one of the two most common stage I-IIIA chemotherapy regimens, either docetaxel/cyclophosphamide or doxorubicin/cyclophosphamide followed by paclitaxel to provide uniformity of prior treatment
Concurrent use of tamoxifen, raloxifene, or any of the aromatase inhibitors
Cases with stage I-IIIB breast cancer that have completed neoadjuvant or adjuvant treatment with anthracyclines and/or taxanes + or – radiation therapy within past 6 months (+/- 7 days) (subjects on concurrent endocrine therapy [tamoxifen (TAM), aromatase inhibitors] are also eligible to participate)
Eligible to receive AHT (tamoxifen or an aromatase inhibitors [AI]) for the first time
All the female breast cancer survivors will be at least two months from receiving cancer treatment (surgery, adjuvant therapy or radiation) and within three years from completing cancer treatment, except for tamoxifen/aromatase inhibitors
Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study
Was prescribed adjuvant therapy with an AI (prior chemotherapy or tamoxifen OK) in past 2 to 4 weeks (Randomized Trial only)
Breast cancer (stage 0, I, II, III), 18 months to 5 years post oncologic therapies of surgery, chemotherapy, and/or radiation therapy (does not exclude current selective estrogen receptor modulators or aromatase inhibitors)
Tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for >= 4 weeks and ust not be expected to stop the medication during the study period
Must be more than six months from ingestion of antihormonal therapy (tamoxifen, raloxifene, other selective estrogen receptor modulators [SERMs], aromatase inhibitors)
Currently receiving tamoxifen or raloxifene
Women eligible to take tamoxifen must be offered tamoxifen prevention as part of their clinical care and have refused tamoxifen treatment
Current treatment with tamoxifen or aromatase inhibitors
Prior use of selective estrogen receptor modulators (SERMS) and aromatase inhibitors (AIs) for prevention or therapy, except for a maximum of 3 months and at least 12 months prior
Current use or < 6 months since use of selective estrogen receptor modulator (SERMS) or aromatase inhibitors or any other investigational treatment for breast cancer prevention or therapy
Is taking risk reduction therapy with tamoxifen
Patients currently on endocrine therapy (tamoxifen, ralozifene or an aromatase inhibitor)
Medications:\r\n* Current anticoagulant use (must discontinue for 3 weeks prior to fine needle aspirate [FNA])\r\n* Taking systemic hormones within two months (eight weeks) prior to screening RPFNA\r\n* Taken tamoxifen, raloxifene, or an aromatase inhibitor within the past 6 months\r\n* Participation on any chemoprevention trial within 6 months
Patients on treatment with tamoxifen
Use of any selective estrogen receptor modulator or aromatase inhibitor within 6 months of randomization, including, but not limited to: tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole
Participants must not have received either chemotherapy or radiotherapy within the previous 6 months; Note: participants receiving long-term adjuvant hormonal therapy (such as tamoxifen or aromatase inhibitors for breast cancer) are allowed
Elevated risk of breast cancer as defined by at least one of the following categories and have declined tamoxifen and/or raloxifene therapy:
Prior tamoxifen or raloxifene use in the past 1 year.
Prior history or current use of tamoxifen or anti-estrogen therapy
Use of any selective estrogen receptor modulator or aromatase inhibitor (tamoxifen, raloxifene, arzoxifene, acolbifine, anastrozole, exemestane, letrozole) within the previous 6 months
Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
Hormonal therapy (tamoxifen, an aromatase inhibitor, or Lupron) is not permitted during radiation or during the subsequent 4 weeks (the entire dose-limiting toxicity [DLT] window)
Participants must have been on adjuvant endocrine therapy, either tamoxifen or aromatase inhibitor (AI), for at least 6 months without any significant adverse events leading to drug interruption for more than 1 month, and must not have had any change in endocrine therapy in the past 6 months; ongoing use of any AI, including letrozole, anastrozole or exemestane, or tamoxifen is allowed; concurrent gonadotrophin releasing hormone (GNRH) agonist is allowed
Women who are receiving endocrine therapy for breast cancer treatment or chemoprevention including tamoxifen, letrozole, anastrozole, fulvestrant, or exemestane at the time of screening
Use of selective estrogen receptor modulators (SERMS) in the past 6 months, including tamoxifen and raloxifene
If undergoing adjuvant therapy (e.g. tamoxifen or aromatase inhibitors) willing and able to remain on current regimen for entire 6-month study period
No history of receiving endocrine therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures; these agents used previously as chemoprevention are allowed
Patient is a postmenopausal woman, man, or premenopausal woman for whom standard endocrine therapy alone (tamoxifen, aromatase inhibitor [AI], with or without ovarian suppression or fulvestrant) is planned after FES-PET/CT is completed
Postmenopausal women, men, or premenopausal women for whom endocrine therapy (tamoxifen, aromatase inhibitor [AI] with or without ovarian suppression or fulvestrant), with or without a CDK4/6 inhibitor is planned after FES-PET/CT is completed.
Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES
Received prior or ongoing local (e.g radiation) or systemic treatment (chemotherapy or endocrine therapy) for the current breast cancer; patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least one month prior to baseline study biopsy
Patients must not have received hormonal therapy (i.e., tamoxifen, raloxifene, and/or aromatase inhibitors) for prevention of breast cancer within 3 months of the biopsy documenting DCIS
Has had hormonal cancer therapy (e.g., tamoxifen, leuprolide). within 4 weeks prior to the first dose of study treatment
TREATMENT GROUP: Elect to undergo, but have not yet started tamoxifen therapy
Current use of aromatase inhibitor as prevention or treatment for breast cancer
Histologically proven stage 0-III carcinoma of the breast, status/post (s/p) surgical resection; radiation therapy and chemotherapy can have been administered, as indicated; concurrent aromatase inhibitor, tamoxifen, trastuzumab, and/or bisphosphonate therapy are permitted
Prior exposure to cisplatin, 5-fluorouracil, tamoxifen, and/or MEK inhibitors within 3 months of enrollment and/or ethambutol and/or hydroxychloroquine within 12 months.
Current or recent use of reproductive hormone therapy, tamoxifen, aromatase inhibitor or other estrogen inhibitors within the last 90 days, which may affect biomarkers