Background, Patients with metastatic breast cancer (MBC) are increasingly exposed to anthracyclines and taxanes either during treatment of primary breast cancer or during initial therapy of metastatic disease. The combination of gemcitabine and carboplatin was therefore investigated as an anthracycline- and taxane-free treatment option;
Methods, Fifty patients with confirmed metastatic breast cancer previously treated were recruited from medical oncology department at South Egypt Cancer Institute starting from the start of July 2009 till the start of December 2012; the study populations were followed till the start of December 2013 in a multicenter phase II study. Treatment consisted of gemcitabine (1,000 mg/m 2 i.v. on days 1 and 8) and carboplatin (AUC 4 i.v. on day 1) applied every 3
weeks; Results, Fifty patients with confirmed MBC were recruited to participate in this study with a treatment protocol approved by the local ethics committee. A total number of 273 cycles were delivered, patients received a median number of 6 and a range of 1-8 cycles, all patients were assessable for response and toxicity. Only three
(6%) achieved CR, twenty-seven (54%) achieved PR, seven (14%) had a stable disease while thirteen (26%) had progressive disease. Thirty-seven patients achieved disease control with a rate of 74% DCR (CR+PR+SD). Median overall survival equals 7.72 months and time to progression equals 5.73 months. The predominant toxicity was hematological which occurred in fifteen (30%) patients and only three (6%) had non-hematological toxicity. Fourteen (28%) had both types of toxicity and eighteen (36%) were free. Main hematological toxicity was grade 2anemia;  sixteen  (32%)  patients  ,  ten  (20%)  had  grade 2  neutropenia  while  nine  (18%)  had  grade  2  and  3
thrombocytopenia, only one (2%) patient had grade 4 neutropenia and no cases experienced febrile neutropenia.
Conclusions, Combination chemotherapy with gemcitabine and carboplatin is an effective and generally well- tolerated treatment option for intensively pretreated patients with MBC.