Cancer Care


Low Dose Metronomic Cyclophosphamide and Methotrexate Chemotherapy in Combination with Aspirin in Patients with Stage II-III Breast Cancer Who Fail to Achieve a Pathologic Complete Response After Neoadjuvant Chemotherapy
Principal Investigator (?)
Study Number
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 (?)
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