Conditions: Breast Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 65
Healthy volunteers: no

Brief summary:
Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.

Detailed description:

Arms:
arm 1: Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).

Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Interventions: intervention 1: gemcitabine intervention 2: doxorubicin intervention 3: cisplatin intervention 4: surgery
Intervention descriptions: intervention 1: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8) intervention 2: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4) intervention 3: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8) intervention 4: Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Protocol document: