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RecruitingPhase 2

Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients

MC250301, OptiOFS: A Randomized Phase II Trial of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether goserelin shots in the upper buttock work as well as shots in the belly to lower hormone production by the ovaries. It is for adults who have not reached menopause and have hormone-sensitive breast cancer that stayed in the breast or spread only nearby.

This phase II trial determines if giving goserelin acetate injections in the upper gluteal region is as effective for ovarian function suppression (OFS) as giving injections in the abdomen for ovarian function suppression (OFS) in premenopausal patients with hormone receptor positive breast cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Goserelin acetate is a drug used to treat prostate cancer, relieve the symptoms of advanced breast cancer, and treat problems with the endometrium (lining of the uterus). Goserelin acetate initially causes the pituitary gland to make more luteinizing hormone (LH) and follicle-stimulating hormone (FSH), temporarily increasing testosterone levels in men and estrogen levels in women. With continued use, goserelin acetate lowers the amount of LH and FSH the pituitary gland releases, leading to a drop in testosterone levels in men and estrogen levels in women. Goserelin acetate may stop the growth of cancer cells that need testosterone or estrogen to grow. It is a type of hormone therapy called a luteinizing hormone-releasing hormone (LHRH) agonist. Giving goserelin acetate injections in the upper gluteal region may be as effective for OFS as giving injections in the abdomen for OFS in premenopausal patients with localized or locally advanced hormone receptor positive breast cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 to 49, with stage I–III breast cancer confirmed by a tissue or cell test. The cancer must be sensitive to estrogen, and you must have finished treatment meant to cure it with no current signs of cancer.
  • Have received monthly goserelin belly shots plus an aromatase inhibitor or tamoxifen (hormone-blocking drugs) for at least 6 months. Plan to keep taking medicine to suppress the ovaries for at least 12 more months.
  • Be able to care for yourself and be up and about at least half of your waking hours.
  • Sign a written consent form and be able to complete surveys, alone or with help.
  • Agree to give blood samples for research and return to the study center for follow-up visits.
  • Have a negative blood pregnancy test within 14 days before signing up and a negative urine pregnancy test within 7 days before assignment to a study group.
  • If sexually active, you and your partner must use effective birth control before joining, during the study, and for at least 3 months after the last study dose. Do not breastfeed or donate sperm during this time.
  • Before assignment to a study group, complete 6 starting treatment cycles of goserelin. Your estradiol (an estrogen hormone) must be below 20 pg/mL, with no two back-to-back levels above 10 pg/mL after the sixth cycle's blood test.

Who can't join

  • You had chemotherapy within 6 months before signing up. Certain other cancer treatments are allowed.
  • You take any medicine containing estrogen or progestin, including estrogen applied to the skin.
  • You plan to pause or stop medicine that suppresses your ovaries within the next 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

MN