A Phase II Randomized Clinical Trial of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
Phase 2
18 Years
65 Years
18 Years
65 Years
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Phase II Randomized Clinical Trial of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
Inclusion Criteria:
- female patients between 18 and 65 years old
- pathological diagnosed invasive breast cancer; medium and high risk primary breast
cancer according to St. Gallen 2007
- able and willing to give consent to participate in the study
Exclusion Criteria:
- pregnant or lactating females
- previous treatment for breast cancer
- other tumor history
- instable complication (e.g., myocardial infarction within 6 months, arrhythmia,
unstable diabetes, hypercalcemia) or uncontrolled infection
- allergy history to similar drugs
- concurrent disease or condition that would make the patient inappropriate for study
participation
- resist to participate in the study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2)
Outcome Time Frame:
within the first 14 days (plus or minus 3 days) after surgery
Safety Issue:
No
Principal Investigator
Tianfeng Wang, Doctor
Investigator Role:
Study Chair
Investigator Affiliation:
Beijing Cancer Hospital Breast Center
Authority:
China: Food and Drug Administration
Study ID:
B04
NCT ID:
NCT00919880
Start Date:
July 2009
Completion Date:
December 2010
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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