JPRN-UMIN000014163
Completed
Phase 2
Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer - A phase II study of Neoadjuvant Eribulin in TNBC patients
ConditionsBreast cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast cancer
- Sponsor
- ational Cancer Center Hospital
- Enrollment
- 43
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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