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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-00968 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 25-006670 | Other Identifier | Mayo Clinic Institutional Review Board | |
| MC250301 | Other Identifier | Mayo Clinic |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Goserelin acetate) | Experimental | Patients receive goserelin acetate SC in the abdomen on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive goserelin acetate SC in the upper gluteal region on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study. |
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| Arm II (Goserelin acetate) | Experimental | Patients receive goserelin acetate SC in the abdomen on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive goserelin acetate SC in the upper gluteal region on day 1 of each cycle. Cycles repeat every 84 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Ovarian function suppression (OFS) maintenance | Failure to maintain OFS (yes; no) is defined as estradiol ≥ 10 pg/mL on two separate occasions. Will be based on calculating the within-arm sample proportion of patients for whom upper gluteal region administration of goserelin for 6 months failed to maintain OFS after switching from monthly abdominal administration of goserelin and corresponding upper bound of the one-sided 97.5% confidence interval (CI). Provided that the upper bound of the one sided 97.5% CI excludes 10%, the primary aim for that arm will have been met. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Provider-reported adverse events (AEs) | Will be scored using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Reported Outcomes and Quality of Life | Assessed by a study-specific questionnaire related to injection pain and post-injection symptoms such as bruising, swelling, or skin irritation. The questionnaire consists of 7 questions, one yes/no question; 5 questions answered on an 11-point scale from 0 (none) to 10 (most you can imagine); and one overall quality of life question answered on a scale of 0 (as bas as it can be) to 10 (as good as it can be). Higher scores for symptom questions indicate more sever symptoms. Any change from baseline will be summarized descriptively. |
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.
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 Ë‚ 20 pg/mL and no back to back E2 levels > 10 pg/mL after cycle 6 blood draw
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Cancer Center Clinical Trials | Contact | 507-293-6386 |
| Name | Affiliation | Role |
|---|---|---|
| Karthik V. Giridhar, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Goserelin Acetate | Drug | Given SC |
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| Questionnaire Administration | Other | Ancillary studies |
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| Injection site preference |
Will be measured by single-question site preference survey (abdomen, upper gluteal region, no preference or unsure). |
| Up to 1 year |
| Baseline, 3 months, 6 months, 9 months, 12 months |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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