A Randomized Study Evaluating the Safety and Effects of the Combination of Palbociclib With Epirubicin and Cyclophosphamide Followed by Paclitaxel as Neoadjuvant Therapy in Triple Negative Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- pCR
研究概览
简要总结
This study will look at effects the combination of palbociclib and dose-dense neoadjuvant chemotherapy may have on triple negative breast cancer tumours which have not yet been treated.
详细描述
Patients will be randomized to one of two treatment arms (1:1 ratio). Dose-Dense neoadjuvant chemotherapy in the first 8 weeks of will be: epirubicin (90mg/m2) and cyclophosphamide (600mg/m2), followed by paclitaxel (80mg / m2) after 8 weeks, cycled every 14 days for total 8 cycles.
Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week [28 days] cycle.
Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
Note:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female patients, 18 years ≤ age ≤ 80 years；
- •Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- •Histologically confirmed invasive breast cancer（early stage or locally advanced）
- •HER2 negative (HER2+/- by IHC or FISH-)
- •Hormone receptor (ER and PR) negative
- •Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
- •Signed informed consent form (ICF)
排除标准
- •Metastatic disease (Stage IV) or inflammatory breast cancer
- •Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.
- •Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- •Unable or unwilling to swallow capsules.
研究组 & 干预措施
Control group
Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
干预措施: Placebo oral capsule (Drug)
Experimental group
Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
干预措施: Palbociclib (Drug)
Experimental group
Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
干预措施: Epirubicin (Drug)
Experimental group
Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
干预措施: Cyclophosphamide (Drug)
Experimental group
Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
干预措施: Paclitaxel (Drug)
Control group
Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
干预措施: Epirubicin (Drug)
Control group
Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
干预措施: Cyclophosphamide (Drug)
Control group
Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
pCR
时间窗: Through study completion, an average of 1 year.
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
次要结局
- ORR(Through study completion, an average of 1 year.)
- DFS(Following surgery until Year 3)
- AEs(baseline and weekly through 12 months after randomization)