A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive/ HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
详细描述
A phase II randomized study of the combination of Ribociclib plus goserelin acetate with Hormonal Therapy versus physician choice chemotherapy in premenopausal or perimenopausal patients with hormone receptor-positive/ HER2-negative inoperable locally advanced or metastatic breast cancer - RIGHT Choice Study
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 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ribociclib 600 mg
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
- Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
- Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
- Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
干预措施: Ribociclib (Drug)
Ribociclib 600 mg
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
- Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
- Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
- Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
干预措施: Letrozole OR Anastrozole (Drug)
Ribociclib 600 mg
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
- Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
- Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
- Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
干预措施: Goserelin (Drug)
Combination Chemotherapy
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
干预措施: Docetaxel / Capecitabine (Combination Product)
Combination Chemotherapy
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
干预措施: Capecitabine / Vinorelbine (Combination Product)
Combination Chemotherapy
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
干预措施: Paclitaxel / Gemcitabine (Combination Product)
结局指标
主要结局
Progression-free Survival
时间窗: Up to approximately 34 months
Progression-free survival was defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause. PFS was censored at the date of the last adequate tumor assessment if no PFS event was observed at the time of last patient, last visit (LPLV).
次要结局
- Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire(Up to approximately 46 months)
- Number of Patients With Adverse Events, Categorized by Severity(Up to approximately 46 months)
- Number of Patients With Laboratory Abnormalities(Up to approximately 46 months)
- Post-Hoc: All Collected Deaths(On-treatment deaths: Up to approximately 46 months. Post-treatment survival follow-up deaths: Up to approximately 2 additional months.)
- Clinical Benefit Rate(Up to approximately 34 months)
- Time to Treatment Failure(Up to approximately 34 months)
- 3-month Treatment Failure Rate(Up to approximately 3 months)
- Overall Response Rate (ORR)(Up to approximately 34 months)
- Time to Response(Up to approximately 34 months)
- Overall Survival (OS)(Up to approximately 46 months)