Goserelin Injection for Hormone-Positive Breast Cancer

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

Recruiting Phase 2 Interventional Study
Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Locally Advanced Hormone Receptor-Positive Breast Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 50
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
98 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for

This trial is looking for premenopausal women with hormone receptor positive breast cancer. Participants will receive goserelin acetate injections to see if taking the injections in a different location is as effective as the traditional site.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 50 years old.
  • I have been diagnosed with localized or locally advanced hormone positive breast cancer.
  • I am currently receiving monthly goserelin injections in the abdomen.
  • I have been taking goserelin and either an aromatase inhibitor or tamoxifen for at least 6 months.
  • I am able to provide written consent.
  • I am willing to give blood samples for research.
  • I can complete questionnaires on my own or with help.
  • I have a negative pregnancy test prior to registration.

You may not be able to join if

  • I have had chemotherapy in the last 6 months.
  • I am currently taking any estrogen or progestin medications.
  • I plan to stop my medical ovarian function suppression in the next 12 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 lym…
Trial Locations
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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 in…
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