A phase II neoadjuvant trial of sequential tri-weekly nanoparticle albumin-bound paclitaxel (Abraxane)/cyclophosphamide, with trastuzumab in HER2-positive patients, followed by 5-fluorouracil/epirubicine/cyclophosphamide (FEC) in operable breast cancer
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000007180
- Lead Sponsor
- Dept of surgical oncology, Hiroshima university hospital
- Brief Summary
The treatment outcomes and safety were evaluated in 54 patients who received at least 1 dose of chemotherapy. The overall pCR rate of 37% was achieved. The pCR rates according to each subtype were 8% in hormone receptor (HR)-positive HER2-negative breast cancer, 56% in HR-positive HER2-positive breast cancer, 63% in HR-negative HER2-positive breast cancer, and 62% in triple-negative breast cancer. Clinical response was observed in 49 patients (91%). The safety profile was acceptable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 54
Not provided
Known hypersensitivity to any of study drugs History of receiving any endocrine therapy or chemotherapy for breast cancer within 5 years prior to registration Concurrent, other malignancies Concurrent bilateral breast cancer (except for contra-lateral non-invasive or lobular breast cancer) Male Concurrent, serious or uncontrolled infections Inadequately controlled or serious history of cardiac disease Inadequately controlled diabetes mellitus Concurrent, gastrointestinal ulceration or bleeding Current pregnancy and lactation, or possibility of pregnancy Assessment by investigator that subject unable to comply with protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pathological complete response (pCR)
- Secondary Outcome Measures
Name Time Method pathological response clinical response safety relapse-free survival
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