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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Процедура Biospecimen Collection
  Undergo blood sample collection
• Другое Electronic Health Record Review
  Ancillary studies
• Препарат Goserelin
  Given SC
• Препарат Leuprolide
  Given IM
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml [Срок оценки: During the first 24 weeks of therapy]

Вторичные конечные точки (8)

• Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml [Срок оценки: At 4 weeks after initial GnRHa treatment administration]
• Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml [Срок оценки: 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 [Срок оценки: Up to 24 weeks]
• Change in FACT-ES Endocrine Symptom Subscale [Срок оценки: Up to 24 weeks]
• Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire [Срок оценки: At the day following initial GnRHa injection]
• Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire [Срок оценки: Before administration of the second GnRHa injection]
• Receipt of GnRHa therapy within ± 1 day of planned dosing [Срок оценки: Up to 24 weeks]
• Incidence of adverse events (AEs) [Срок оценки: Up to 24 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan Comprehensive Cancer Center — Ann Arbor

Идентификаторы

NCT: NCT07158021 · UMCC 2025.016 · NCI-2025-03933 · HUM00270281

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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