Low Dose Chemotherapy With Aspirin in Patients With Breast Cancer After Neoadjuvant Chemotherapy
Status:
Unknown status
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
Patients with stage II-III breast cancer who do not achieve a pathologic complete response to
neoadjuvant chemotherapy at the time of surgery will be treated with oral low dose continuous
cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and
radiotherapy. The primary endpoint is to assess toxicity and safety with secondary endpoints
of cytokine correlates and relapse free survival (RFS) at 2 years. The investigators design
tests the null hypothesis (H0) that the true primary toxicity event rate will be 5% or less,
against an alternative hypothesis (HA) event rate of 25% or more.
Phase:
N/A
Details
Lead Sponsor:
University of Vermont
Collaborators:
Dartmouth-Hitchcock Medical Center Maimonides Medical Center