A Multicenter, Randomized, Phase II Trial Evaluating the Efficacy of Eribulin Monotherapy and Eribulin Plus Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients After Progression on Endocrine Therapy (REVERT)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 9
- 主要终点
- The overall response rate (ORR)
研究概览
简要总结
Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).
详细描述
Pre- and post-menopausal women age ≥ 18 years with unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC) with no prior line of chemotherapy in the metastatic setting, and that have shown progression while on an aromatase inhibitor-containing regimen in the metastatic setting or within six months from last aromatase inhibitor dose in the adjuvant setting. Patients must have received at least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting. Subjects must have adequate bone marrow and creatinine clearance functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •ER-positive and/or PR-positive breast cancer.
- •HER2-negative breast cancer.
- •Unresectable locally advanced or metastatic breast cancer.
- •Confirmed disease progression while in the last aromatase inhibition-containing regimen in the metastatic setting.
- •At least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting.
- •Patients with no prior line of chemotherapy in the metastatic setting.
- •At least 1 and up to 3 prior lines of endocrine therapy in the metastatic setting.
- •ECOG score 0 or
- •Patients have adequate bone marrow and organ function.
- •Patients must have measurable disease (RECIST v.1.1).
- •Premenopausal with LHRH analogues for at least 28 days) and postmenopausal women.
- •Patients must agree to not breastfeed during the study and for 3 months after the last dose of study treatment.
- •Life expectancy greater or equal to 12 weeks.
- •Patients agree to collection of blood samples (liquid biopsy) and optional collection of metastatic tumour sample (biopsy) at the time of inclusion and progression (if appropriate).
排除标准
- •Have received radiation therapy or limited-field palliative radiotherapy within two weeks prior to Cycle 1, Day 1, or patients who have not recovered from radiotherapy-related toxicities.
- •Have received prior chemotherapy for locally advanced or metastatic disease.
- •Have peripheral neuropathy grade 2 or greater.
- •QTc > 480 msec on basal assessments, history of congenital or personal history of long QT syndrome, Brugada syndrome, or Torsade de Pointes (TdP), or uncontrolled electrolyte disorders
- •Child-bearing potential women not using highly effective methods of contraception.
- •Known hypersensitivity to eribulin, endocrine therapy or its excipients.
- •Other malignancies within the previous two years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix or breast.
- •Known uncontrolled metastases to the central nervous system (CNS) or any progressing CNS disease.
- •Have a serious concomitant systemic disorder incompatible with the study.
- •Major surgical procedure or significant traumatic injury within 28 days prior to randomization.
- •Have received any anti-cancer biology or investigational treatment within 30 days prior to randomization.
研究组 & 干预措施
Eribulin monotherapy
Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle
干预措施: Eribulin (Drug)
eribulin plus endocrine therapy
Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle, in combination with endocrine therapy (aromatase inhibitor). AI must be identical to the last AI administered to the patient, whether in the adjuvant or metastatic setting.
干预措施: Eribulin (Drug)
结局指标
主要结局
The overall response rate (ORR)
时间窗: Baseline up to 27 months
The overall response rate (ORR) in the eribulin + ET arms, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
次要结局
- The progression-free survival (PFS)(Baseline up to 27 months)
- The duration of response (DOR) in the eribulin and the eribulin + ET arms(Baseline up to 27 months)
- Maximum Tumor shrinkage(Baseline up to 27 months)
- The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms(Baseline up to 27 months)
- PFS-2, in the eribulin and the eribulin + ET arms(Baseline up to 27 months)
- Overall response rate (ORR) in the eribulin arm(Baseline up to 27 months)
- The overall survival (OS) in the eribulin and the eribulin + ET arms(Baseline up to 27 months)