Leuprolide versus goserelin to stop ovarian estrogen production in pre- or peri-menopausal women with breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II clinical comparison of two doses of leuprolide versus standard-dose goserelin for ovarian function suppression in pre- or peri-menopausal women with breast cancer. Participants receive one of the leuprolide doses or goserelin alongside oral endocrine therapy and are followed for six months. The study measures estrogen suppression using blood tests, collects biospecimens, reviews electronic health records, and uses questionnaires to track tolerability and safety. The goal is to determine whether lower or higher dose leuprolide provides comparable ovarian suppression and side-effect profile to goserelin.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female subject aged ≥ 18 years
* Pre- or peri-menopausal patient, who had (1) menses either within the 12 months prior to or since breast cancer diagnosis or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance either within the 12 months prior to or since breast cancer diagnosis.
* Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for treatment of metastatic breast cancer. Prior treatment with GnRHa therapy for treatment of non-oncologic conditions or during chemotherapy is permitted.
* Not planning bilateral salpingo-oophorectomy during the 6-month study duration
* Completion of chemotherapy, if given. Concurrent use of trastuzumab, pertuzumab, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, cyclin D kinase 4/6 (CDK4/6) inhibitor, and/or phosphoinositide 3-kinase (PI3K) inhibitor therapy is permitted
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria:

* Prior bilateral salpingo-oophorectomy
* Known to be pregnant or breastfeeding (negative pregnancy test will be confirmed prior to study treatment initiation)
* Concomitant use of systemic or transdermal estrogen products
* Known allergy or hypersensitivity to goserelin or leuprolide, or any of the excipients in the medications
* Unable to take oral medications
* Any medical condition that would interfere with the absorption of endocrine therapy. Prior gastric bypass is permitted
* Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen

Where it's running

• University of Michigan Comprehensive Cancer Center
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Norah L Henry — University of Michigan Rogel Cancer Center
• Study coordinator: Cancer AnswerLine
• Email: CancerAnswerLine@med.umich.edu
• Phone: 1-800-865-1125

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blended e-Health Program to Help Women with Breast or Gynecologic Cancer Manage Fear of Cancer Progression

  This trial tests a blended online and group program to see if it helps women with breast or gynecologic cancer feel less fear that their cancer could grow or spread.

  Recruiting at 11 sites City of Hope Medical Center · Arcadia, California and 10 other locations · NCT07741968

• Measuring a biomarker for breast cancer treatment effectiveness

  This study is testing if measuring a specific biomarker can help doctors understand how well hormone treatments are working for people with advanced breast cancer.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT06388122

• Personalized tumor vaccine with checkpoint inhibitors for triple negative breast cancer

  This phase I trial will test whether a personalized tumor membrane vesicle (TMV) vaccine, given alone or with pembrolizumab or ipilimumab, can boost immune response and help control disease in adults with triple negative breast cancer.

  Recruiting at 4 sites Phase 1 Emory University · Atlanta, Georgia and 3 other locations · NCT06324240

• Using minoxidil to treat hair loss in breast cancer patients on endocrine therapy

  This study is testing if a hair loss treatment called minoxidil, given either as a foam or a pill, can help women with breast cancer who are losing their hair due to cancer therapy.

  Recruiting Early Phase 1 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT05417308

• Navigation program to boost survivorship support participation for non-metastatic breast cancer survivors

  This program tests whether a patient navigation service helps non-metastatic breast cancer survivors use survivorship support services more often.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07699991

• Personalized Exercise Plan for Breast Cancer Survivors on Chemotherapy

  This trial tests whether adding a guided exercise program to a healthy-lifestyle education plan helps breast cancer patients undergoing chemotherapy maintain fitness, heart health, and quality of life.

  Recruiting at 3 sites Wake Forest University Health Sciences · Winston-Salem, North Carolina and 3 other locations · NCT07474090

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.