Conditions: Breast Cancer
Keywords: Breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 152
Healthy volunteers: no

Brief summary:
The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.

Detailed description:

Arms:
arm 1: oral vinorelbine (OV) with capecitabine (CAP) arm 2: gemcitabine (GEM) in combination with paclitaxel (PAC) arm 3: gemcitabine (GEM) in combination with docetaxel (DOC)

Interventions: intervention 1: oral vinorelbine intervention 2: Capecitabine intervention 3: Gemcitabine 1250 mg/m² intervention 4: Gemcitabine 1000 mg/m² intervention 5: Paclitaxel intervention 6: Docetaxel
Intervention descriptions: intervention 1: Oral vinorelbine 60 mg/m² on day 1 \& day 8, for cycle 1, and then 80 mg/m² on day 1 \& day 8, every 3 weeks for subsequent cycles intervention 2: Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14 intervention 3: Gemcitabine 1250 mg/m² on day 1 \& day 8 intervention 4: Gemcitabine: 1000 mg/m² on day 1 \& 8 intervention 5: Paclitaxel 175 mg/m² on day 1 intervention 6: Docetaxel 75 mg/m² on day 1

Protocol document: