The purpose of this study is to assess the response of docetaxel and gemcitabine in the neoadjuvant setting in women with locally advanced breast cancer.
Neoadjuvant chemotherapy is now standard for patients with locally advanced breast cancer, and this method of treatment has been extended to patients with earlier disease without affecting the treatment outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of docetaxel and gemcitabine in the neoadjuvant setting with locally advanced breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles
gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles
Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
Suwon, Gyeonggi-do, South Korea
Complete remission rate was assessed by pathologic examination after surgery.
Time frame: 2 years
Type of surgery (Breast Conserving Rate)
Time frame: 6 month
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 1 year
progression free survival
Time frame: 2 years
quality of life
Time frame: 2 years
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