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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Anlotinib plus DCb
Guangdong Women and Children Hospital
Guangzhou, Guangdong, China
Pathologic Complete Response(PCR)
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
Time frame: Up to approximately 20-25 weeks
event-free survival(EFS)
defined as time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral \[invasive or non-invasive\]), or death from any cause
Time frame: Up to approximately 24 months
Safety and Tolerability
Incidence, type, and severity of all adverse events (including serious adverse events) based on NCI CTCAE, v4.0.
Time frame: Up to approximately 20-25 weeks
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Enrollment
30