A phase II study of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil + epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer (JBCRG-13)
- Conditions
- Operable triple negative or low hormone receptors/HER2 negative primary breast cancer
- Registration Number
- JPRN-UMIN000003570
- Lead Sponsor
- Japan Breast Cancer Research Group (JBCRG)
- Brief Summary
Results: pCR was achieved after mPCX and FEC by 47.5 % (19/40) of patients in the ITT population and in 54.5% (18/33) of patients in the PPS. The clinical response rate was 90.0% (36/40) in the ITT population and 93.9% (31/33) in the PPS. Breast conservation surgery was possible in six patients (40%) who were scheduled to undergo total mastectomy. Conclusion: Metronomic PCX followed by FEC chemotherapy was associated with a high pCR rate and low toxicity in patients with TNBC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 41
Not provided
1) Prior chemotherapy or endocrine therapy in the past 5 years. 2) Active double cancer. 3) Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 4) Male patient. 5) Infection or suspected infection. 6) Serious cardiac disorder or preexisting cardiac disease. 7) Uncontrolled diabetes. 8) Gastrointestinal ulceration or gastrointestinal bleeding. 9) Other serious complication. 10) History of drug-hypersensitivity 11) Ineligible based on decision of an investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method