Phase 2 Randomized Trial to Examine Ovarian Function Suppression for Breast Cancer (OFS)
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.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherElectronic Health Record Review
Ancillary studies
- DrugGoserelin
Given SC
- DrugLeuprolide
Given IM
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml
Analyses will primarily be descriptive reporting the overall and by treatment group proportions of women with ultrasensitive estradiol concentration and the corresponding exact binomial 95% confidence intervals over the first 24 weeks of gonadotropin releasing hormone agonist (GnRHa) therapy.
Time frame: During the first 24 weeks of therapy
Secondary
Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml
Time frame: At 4 weeks after initial GnRHa treatment administration
Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml
Time frame: Any time after 4 weeks of initial GnRHa treatment administration, assessed cycle 3 day 1-cycle 7 day 1 (cycle length = 28 days)
Change in Functional Assessment of Cancer Therapy-(FACT)-Endocrine Subscale (ES) Trial Outcome Index
Time frame: Up to 24 weeks
Change in FACT-ES Endocrine Symptom Subscale
Time frame: Up to 24 weeks
Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire
Time frame: At the day following initial GnRHa injection
Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire
Time frame: Before administration of the second GnRHa injection
Receipt of GnRHa therapy within ± 1 day of planned dosing
Time frame: Up to 24 weeks
Incidence of adverse events (AEs)
Time frame: Up to 24 weeks
Eligibility criteria
Study locations (1)
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109