We conducted a phase II trial to define the safety, the efficacy, the pathological response rate and survival associated with four cycles DXR-GMZ administered every 3 weeks followed by surgery, then four cycles of FAC50 as a primary therapy in MBC.

Patients with histologically or cytologically confirmed MBC, ECOG PS: 2 and adequate hepatic, renal and cardiac functions were eligible. Prior chemotherapy was not allowed.

Fifty-one patients were included, after signing an informed consent. Median age was 47.07 years, and 100% had stage IV. A total of 373 cycles was administrated. Main grade 3/4 toxicities were neutropenia in 1.1 %, anaemia in 0.5% and thrombopenia grade 2 in 1.1%. Nausea and vomiting grade 2–3 occurred in 17.4%. Regarding efficacy, 49 out of 51 patients achieved four cycles. The overall response rate was in 84.1%, with complete response in 58.8% and partial response in 25.3%. Progression of disease occurred in 2.4%. Surgery was performed in 30 patients, and 13 had histological response (43.2%), with complete histological response in 36.6% and partial histological response in 6.6 %. The median time to progression was 13.3 months.

The combination of DXR with GMZ in MBC appears to be an active regimen with a favourable toxicity profile. It is well tolerated and achieved encouraging pathological response rates.