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Phase 2 Randomized Trial to Examine Ovarian Function Suppression for Breast Cancer (OFS)

Primary Investigator
Henry, Lynn
Status
OPEN TO ACCRUAL
Phase
II
NCT Number
NCT07158021
UM Number
2025.016
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Breast Oncology
ID (Protocol)
60930
Secondary Protocol No
HUM00270281
Scope
Unspecified
Sponsor Type
National
Disease Site
Breast
Summary
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.

Eligibility: Inclusion Criteria
  •   * Female subject aged >= 18 years
  •   * Pre- or peri-menopausal patient, who had (1) menses within the 12 months prior to enrollment or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance within the 12 months prior to enrollment
  •   * 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
  •   * 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
  •   * Pregnant or breast feeding, or plan to become pregnant during the study period
  •   * 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