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NCT07460752 · ClinicalTrials.gov registry record · Phase 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
A Phase 2 study, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT07460752: Recruiting Phase 2 study, sponsored by Mayo Clinic.
NCT07460752 is a Phase 2 study that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07460752, a Phase 2 study, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- DRUG Goserelin Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2026-05-22 |
| Est. Completion | 2029-09-26 |
| Phase | Phase 2 |
What NCT07460752 shows while recruiting
NCT07460752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT07460752 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07460752 about?
NCT07460752 is a clinical study titled "Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients". 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 t...
What is the current status of trial NCT07460752?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2026-05-22. Estimated completion is 2029-09-26.
What interventions are being tested in trial NCT07460752?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Goserelin Acetate (DRUG).
Who is sponsoring clinical trial NCT07460752?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07460752's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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