Efficacy and Safety of Apatinib Added to Docetaxel and Cisplatin Neoadjuvant Therapy for Patients With Breast Cancer: a Randomized, Parallel Controlled Phase II Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary endpoint is pathological complete remission (pCR)
研究概览
简要总结
To verify the role of apatinib in neoadjuvant therapy for breast cancer, the investigators designed a prospective, randomized, parallel-controlled phase II/III trial, to investigate the efficacy and safety of apatinib combined with TP (paclitaxel + cisplatin) or TP regimen alone as neoadjuvant therapy for stage II-III breast cancer treatment. 100 cases of eligible patients were diagnosed by core needle biopsy and immunohistochemistry, with the molecular subtypes of triple-negative, HER2+ or Luminal B, evaluated by pathological complete remission (pCR), objective response rate (ORR), adverse events, disease free survival (DFS) and OS, aiming at providing a new way for neoadjuvant therapy in breast cancer and anti-angiogenic treatment of malignant tumors.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast invasive carcinoma diagnosed by core needle biopsy, without previous treatments for breast cancer;
- •with the molecular subtypes of triple-negative, HER2+ or Luminal B, confirmed by immunohistochemistry;
- •breast cancer within stage IIb-IIIc, planned to receive neoadjuvant therapy;
- •women aged from 18 to 70 years old;
- •required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- •left ventricular ejection fraction (LVEF) greater than 55% without clinical symptoms or signs of heart failure;
- •Adequate bone marrow, with white blood cell ≥4.0×109 /L，neutrophils ≥2.0×109 /L, platelet ≥100×109 /L, hemoglobin ≥ 90 g/L；
- •Serum creatinine ranges from 44 to 133 mol/L;
- •Glutamic pyruvic transaminase and Glutamic-oxalacetic Transaminase ≤2 times to superior limit of normal value;
- •bilirubin ≤ superior limit of normal value;
- •Expected survival ≥ 12 months;
- •pregnancy tests must be negative, and the couples of patients should agree to use effective contraception during treatment and the following one year;
- •approved by the institutional ethnics committee of the Fourth Hospital of Hebei Medical University, with signature to the Informed consent.
排除标准
- •severe systemic infection;
- •being allergic or intolerant to apatinib, paclitaxel, cisplatin;
- •having received any testing drugs, radiotherapy or other chemotherapy drugs within 30 days before being enrolled in this trial;
- •uncontrolled hypertension, severe heart function;
- •researchers believe that participating in the test does not meet the best interests of the patients (e.g. cause adverse health) or may interfere with the evaluation of response.
研究组 & 干预措施
apatinib+TP
TP neoadjuvant chemotherapy (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3) combined with apatinib (received TP concurrently with apatinib 500mg, day1-21).
干预措施: Apatinib (Drug)
apatinib+TP
TP neoadjuvant chemotherapy (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3) combined with apatinib (received TP concurrently with apatinib 500mg, day1-21).
干预措施: paclitaxel (Drug)
apatinib+TP
TP neoadjuvant chemotherapy (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3) combined with apatinib (received TP concurrently with apatinib 500mg, day1-21).
干预措施: cisplatin (Drug)
TP
TP neoadjuvant chemotherapy alone (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3).
干预措施: paclitaxel (Drug)
TP
TP neoadjuvant chemotherapy alone (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3).
干预措施: cisplatin (Drug)
结局指标
主要结局
The primary endpoint is pathological complete remission (pCR)
时间窗: 4 months
pCR was defined as no histological evidence of invasive tumor cells in the surgical breast specimen and draining nodes. The presence of residual ductal carcinoma-in situ was not included in the pCR category after neoadjuvant treatment.
次要结局
- The second endpoint includes the objective response rate (ORR)(4 months)
- Adverse events (AE)(4 months)
研究者
Liu Yunjiang
Professor, Director and Vice-president
Hebei Medical University Fourth Hospital