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RecruitingPhase 2

Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial

Phase 2 Interventional Trial of Ovarian Function Suppression for Breast Cancer (OFS)

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 and older
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 compares two doses of leuprolide with goserelin to see how well they lower estrogen made by the ovaries. It also compares their safety and side effects. It is for women with breast cancer who have not finished menopause, when periods stop for good.

This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. Both doses of leuprolide may be as safe, tolerable and/or effective as goserelin in suppressing ovarian function in pre- or peri-menopausal women with 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

  • You are a woman age 18 or older.
  • You have not finished menopause. You had a period or an estrogen level above the range seen after menopause within 12 months before your breast cancer diagnosis or any time since.
  • You plan to take medicine that stops the ovaries from making estrogen along with hormone pills: tamoxifen, anastrozole, exemestane, or letrozole. This is for stage 1–3 breast cancer or breast cancer that has spread to other parts of the body.
  • You may have used medicine to stop the ovaries from making estrogen for a condition other than cancer or during chemotherapy.
  • You do not plan to have both ovaries and fallopian tubes removed during the 6-month study.
  • You have finished chemotherapy, if you received it. Some other cancer treatments and bone medicines are allowed during the study.
  • You can give informed consent and are willing to sign a form agreeing to join the study.

Who can't join

  • You have had both ovaries and fallopian tubes removed.
  • You are pregnant or breastfeeding. A negative pregnancy test is required before study treatment starts.
  • You use estrogen products that act throughout the body, including estrogen patches.
  • You have a known allergy to goserelin, leuprolide, or any ingredient in these medicines.
  • You cannot take medicines by mouth.
  • You have a health problem that keeps your body from absorbing hormone treatment. Past gastric bypass surgery is allowed.
  • You have another current or past cancer that the study doctor thinks could affect how the study treatment’s safety or results are judged.

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

Official eligibility criteria

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

Study sites (1)

MI