The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel plus carboplatin preoperative regimen.
Breast cancer is the leading cause of cancer in women in China. Preoperative chemotherapy for treatment of locally advanced breast cancer has become a standard therapy. Results from neoadjuvant trials have shown that pathological complete response (pCR) is an independent predictor of outcome. Paclitaxel was introduced into clinical practice in the early 1990s and has demonstrated good activity in the adjuvant and metastatic settings. Platinum complexes, like cisplatin and carboplatin, are active in a wide range of solid tumors. Paclitaxel combined with carboplatin has shown great activity in ovarian and nonsmall- cell lung cancer treatment. In addition, the overall response rate of paclitaxel plus carboplatin was between 53% and 62% in the first-line treatment of metastatic breast cancer. This study will evaluate the pCR rate of weekly paclitaxel plus carboplatin as preoperative treatment for breast cancer patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Paclitaxel 80 mg/m2, carboplatin AUC of 2 mg/min/ml, given on days 1, 8 and 15 of a 28-day cycle.
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
pathological complete remission (pCR) rate
Time frame: after 4 cycles of preoperative treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
From the first dose of neoadjuvant chemotherapy to definitive surgery or disease progression
Time frame: 4 months during neoadjuvant therapy
clinical response rate
Time frame: after 4 cycles of preoperative therapy
Predictive markers of weekly paclitaxel plus carboplatin
Time frame: after 4 cycles of preoperative treatment
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