Phase 2 Study of Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer Patients
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
pathological complete remission (pCR) rate
after 4 cycles of preoperative treatment
No
Kunwei Shen, Dr
Principal Investigator
Shanghai Jiao Tong University School of Medicine
China: Ethics Committee
DXK200801
NCT01203267
December 2007
December 2008
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