Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000014163
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 43
Not provided
1) Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant 2) Patients with active infection 3) Patients with respiratory failure requiring oxygen inhalation therapy 4) Patients with signs or symptoms of interstitial pneumonia or pulmonary fibrosis 5) Patients who are HBs antigen-positive, HCV antibody-positive and/or HIV antibody-positive 6) Patients with diabetes mellitus associated with poor glycemic control 7) Patients with psychiatric illness that would prevent informed consent 8) Patients with history of allergy to eribulin mesylate, epirubicin hydrochloride, fluorouracil or cyclophosphamide hydrate 9) Patients with cancer within five years, not including breast cancer and lesions equivalent to carcinoma in situ or mucosal carcinoma considered healed with topical therapy 10) Patients with a history of invasive breast cancer 11) Prior treatment with Epirubicin Hydrochloride >500mg/m2 12) Patients who have a previous and concurrent inflammatory breast cancer 13) Patients otherwise considered ineligible for enrollment in the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response rate, which is defined as the absence of viable invasive tumor in both the breast and the axillary nodes, or residual ductal carcinoma in situ (DCIS) in breast and no viable invasive tumor in the axillary nodes.
- Secondary Outcome Measures
Name Time Method 1) Clinical response rate 2) Disease-free survival 3) Breast-conservation rate 4) Adverse events