Neoadjuvant Treatment Anlotinib Combined With Docetaxel and Carboplatin in Triple-negative Early-stage Breast Cancer : a Multicenter, Open, Single-arm Phase II Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response(PCR)
研究概览
简要总结
DCb (docetaxel/carboplatin) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer have been recommended by NCCN guideline.Combination of anti-angiogenesis inhibitors is expected to further improvePathologic Complete Response(PCR).This study is to evaluate the efficacy and safety of ADCb (Anlotinib/docetaxel/carboplatin) as Neoadjuvant Treatment in Triple-Negative breast cancer. The endpoint of PCR is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
详细描述
Triple negative breast cancer (TNBC) accounts for 15-20% of all invasive breast cancer,it is a subtype lacking estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor type 2 (HER2) amplification. The mainstay of treatment for TNBC is cytotoxic chemotherapy. However, despite its sensitivity to chemotherapy, TNBC is still associated with a poor prognosis and a higher risk of visceral transfer.
The benefits of neoadjuvant therapy include reducing the size of the tumor to suit breast conserving surgery, avoiding axillary lymph node dissection, making inoperable tumors operable, and obtaining an in vivo evaluation of the tumor's chemosensitivity.TNBC is usually recommended for neoadjuvant therapy. Taxane- and anthracycline-based neoadjuvant regimens have become a standard treatment for TNBC, and patients have been proved to have better event-free survival (EFS) and overall survival (OS) who achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy.Previous studies have shown that adding carboplatin to neoadjuvant chemotherapy regimens significantly improved pCR rate in TNBC patients.The use of immunotherapy, parp inhibitors, and anti-angiogenesis inhibitors can improve PCR for triple-negative breast cancer neoadjuvant therapy.
This study was designed to see the efficacy and safety of Anlotinib plus docetaxel and carboplatin Neoadjuvant Treatment for Triple-Negative Breast Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- •Stage IV (metastatic) breast cancer
- •Patients with a history of invasive breast cancer.
- •Patients with a history of ductal carcinoma in situ (DCIS), except for patients treated exclusively with mastectomy > 5 years prior to diagnosis of current breast cancer
- •Patients with bilateral breast cancer
- •Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer.
- •Patients who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
- •History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
- •Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders)
- •Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
- •Current pregnancy and/or breastfeeding
研究组 & 干预措施
ADCb
Anlotinib (anlotinib 12mg qd p.o. d1-14/21day/cycle)and Docetaxel (75 mg/m2 administered intravenously every 3 weeks) and carboplatin (area under the concentration-time curve [AUC] 6, intravenously every 3 weeks) for six cycles
干预措施: Anlotinib (Drug)
结局指标
主要结局
Pathologic Complete Response(PCR)
时间窗: Up to approximately 20-25 weeks
Local evaluation of pCR defined as the absence of any residual invasive cancer of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/is, ypN0 in the current AJCC staging system
次要结局
- Safety and Tolerability(Up to approximately 20-25 weeks)
- event-free survival(EFS)(Up to approximately 24 months)
研究者
Anqin Zhang
Chief Physician
Guangdong Women and Children Hospital