Phase 2 Interventional Trial of Ovarian Function Suppression for Breast Cancer (OFS)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml
研究概览
简要总结
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.
详细描述
13MAY2026- New Amendment approved which made the following changes:
- Study title updated reflect updated trial design
- Arms updated to reflect study drug dosing assignments
- Eligibility Criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm II (leuprolide)
Leuprolide 7.5 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Electronic Health Record Review (Other)
Arm II (leuprolide)
Leuprolide 7.5 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Leuprolide (Drug)
Arm III (goserelin)
Goserelin 3.6 mg q4 weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Electronic Health Record Review (Other)
Arm II (leuprolide)
Leuprolide 7.5 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Questionnaire Administration (Other)
Arm I (leuprolide)
Leuprolide 3.75 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm I (leuprolide)
Leuprolide 3.75 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Electronic Health Record Review (Other)
Arm I (leuprolide)
Leuprolide 3.75 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Questionnaire Administration (Other)
Arm II (leuprolide)
Leuprolide 7.5 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm III (goserelin)
Goserelin 3.6 mg q4 weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm III (goserelin)
Goserelin 3.6 mg q4 weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Questionnaire Administration (Other)
Arm III (goserelin)
Goserelin 3.6 mg q4 weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Goserelin (Drug)
Arm I (leuprolide)
Leuprolide 3.75 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
干预措施: Leuprolide (Drug)
结局指标
主要结局
Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml
时间窗: During the first 24 weeks of therapy
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.
次要结局
- Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml(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(Up to 24 weeks)
- Change in FACT-ES Endocrine Symptom Subscale(Up to 24 weeks)
- Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire(Before administration of the second GnRHa injection)
- Receipt of GnRHa therapy within ± 1 day of planned dosing(Up to 24 weeks)
- Incidence of adverse events (AEs)(Up to 24 weeks)
- Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml(At 4 weeks after initial GnRHa treatment administration)
- Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire(At the day following initial GnRHa injection)