Phase I/II trial of metronomic chemotherapy with daily dalteparin and cyclophosphamide, twice-weekly methothrexate, and daily prednisone (DalCMP) as therapy for metastatic breast cancer (MBC).

1152 Background: We recently published data on 41 patients (pts) treated with DalCMP (JCO 2009). We have now accrued additional pts to further compare responses in pts treated or not with prior anthracycline (A) and taxane (T) based regimens. Methods: Pts with measurable MBC received daily sc dalteparin (5,000UI), po cyclophosphamide (50mg), twice weekly po methothrexate (2.5mg BID) and daily po prednisone (5mg). Primary study endpoint was clinical benefit rate (CBR) (i.e., complete response [CR] + partial response [PR] + prolonged stable disease for ≥ 24 weeks [pSD]). Secondary endpoints included time to progression (TTP), duration of response (DOR), and overall survival (OS). Pts were in group 1 (no prior chemotherapy for metastatic disease) or group 2 (prior A and T for metastatic disease, or prior adjuvant A and T if relapse < 1 year, or prior adjuvant A and prior T for metastatic disease). Adverse events were assessed by common toxicity criteria version 2 (CTCAE). Kaplan-Meier methods and log rank te...