Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer Patients|
- pathological complete remission (pCR) rate [ Time Frame: after 4 cycles of preoperative treatment ] [ Designated as safety issue: No ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 months during neoadjuvant therapy ] [ Designated as safety issue: Yes ]From the first dose of neoadjuvant chemotherapy to definitive surgery or disease progression
- clinical response rate [ Time Frame: after 4 cycles of preoperative therapy ] [ Designated as safety issue: No ]
- Predictive markers of weekly paclitaxel plus carboplatin [ Time Frame: after 4 cycles of preoperative treatment ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: paclitaxel plus carboplatin (PCb) Arm
4 cycles of neoadjuvant paclitaxel plus carboplatin
Drug: Paclitaxel, Carboplatin
Paclitaxel 80 mg/m2, carboplatin AUC of 2 mg/min/ml, given on days 1, 8 and 15 of a 28-day cycle.
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.
|Fudan University Cancer Hospital|
|Shanghai, Shanghai, China, 200032|
|Principal Investigator:||Kunwei Shen, Dr||Shanghai Jiao Tong University School of Medicine|