Clareo Health | Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients
Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients
REGISTRATION (STEP 1): Age ≥ 18 years and ˂ 50 years
REGISTRATION (STEP 1): Have histologically or cytologically confirmed, localized or locally advanced hormone positive breast cancer stage I-III (defined as ER Immunohistochemistry (IHC) \> 1%\] having completed curative intent therapy and clinically in remission
REGISTRATION (STEP 1): Currently receiving ovarian function suppression (OFS) with use of goserelin on a monthly basis in the abdomen and either aromatase inhibitor or tamoxifen for at least 6 months prior to study enrollment for treatment of hormone receptor positive breast cancer with plan to continue medical OFS for at least the next 12 months
REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
REGISTRATION (STEP 1): Provide written informed consent
REGISTRATION (STEP 1): Ability to complete questionnaire(s) by themselves or with assistance
REGISTRATION (STEP 1): Willingness to provide mandatory blood specimens for correlative research
REGISTRATION (STEP 1): Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
REGISTRATION (STEP 1): Negative serum pregnancy test =\< 14 days prior to registration, and a negative urine pregnancy test =\< 7 days prior to randomization
REGISTRATION (STEP 1): Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug.
* Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 12 months postmenopausal; or injectable or implantable agent/device. Male patients should refrain from sperm donation and female patients should refrain from breastfeeding throughout this period
RANDOMIZATION (STEP 2): Completion of the lead-in treatment of 6 cycles of ovarian function suppression (OFS) with use of goserelin, with estradiol E2 value of ˂ 20 pg/mL and no back to back E2 levels \> 10 pg/mL after cycle 6 blood draw
You may not be if
REGISTRATION (STEP 1): Any of the following prior therapies: Chemotherapy =\< 6 months prior to registration. NOTE: concurrent receipt of human epidermal growth factor receptor 2 (HER2) directed antibodies or antibody-drug conjugates, endocrine therapy, or cyclin-dependent kinase (CDK) 4/6 inhibitor is permitted
REGISTRATION (STEP 1): Receiving any estrogen or progestin containing medications, including topical estrogens
REGISTRATION (STEP 1): Planning to temporarily or permanently discontinue medical OFS in the next 12 months
