An Open-label, Multi-center Phase II Trial to evaluate the efficacy and Safety of Combination Chemotherapy With DoceTaxel and Gemcitabine
Not Applicable
Recruiting
- Conditions
- Neoplasms
- Registration Number
- KCT0000312
- Lead Sponsor
- Korean Breast Cancer Society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 99
Inclusion Criteria
1.pathologically proved breast cancer
2. no distant metastasis confirmed pathologically or radiologically
3. 20-70 years old female
4. ECOG performance: 0~2
5. No previous anti-cancer treatment
6. more than one lesion measurable by chest CT
7. Ample bone marrow, liver, kidney function within 2 weeks
8. Mentally sound person understanding her rights to ban the clinical trial and protocol/ ICF.
Exclusion Criteria
1. distant metastasis from breast cancer
2. HER-2 (+)
3. active cancer otherwise breast cancer (except cervix CIS or basal/squamous cell carcinoma which are properly treated)
4. Pregnancy, during lactation
5. Within 6 months, clinically significant heart problems
6. Uncontrollable systemic infection
7. male
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pathologic complete remission
- Secondary Outcome Measures
Name Time Method breast conserving rate; clinical remission rate,;toxicity