Phase 2 study of dose dense AC and dose dense PTX as perioperative chemotherapy for patients with HER2 negative breast cancer(WJOG9016B)
Phase 2
- Conditions
- HER2 negative breast cancer
- Registration Number
- JPRN-UMIN000024992
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
1) Active double cancer 2) Active infection 3) Lactating, pregnant, or not willing to contraception women 4) Mental disorders 5) On steroids or immune suppressants 6) History of severe hypersensitivity 7) History of severe complication 8) Judged as inappropriate to be included study by treating physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of high RDI, defined as the proportion of patients whose RDI of the therapy exceeds 85 % among those who started treatment
- Secondary Outcome Measures
Name Time Method 1) Mean and median RDI of the whole therapy 2) Mean, median and the proportion of high RDI of ddAC 3) Mean, median and the proportion of high RDI of ddPTX 4) The proportion of patients without delay & dose reduction 5) Safety (including SAE) 6) ORR, BCR, pCR, and recurrence of the neoadjuvant treatment 7) Recurrence rate of the adjuvant treatment