Conditions: Breast Neoplasms
Keywords: advanced breast cancer sunitinib docetaxel Phase 3
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 594
Healthy volunteers: no

Brief summary:
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sunitinib malate intervention 2: Taxotere
Intervention descriptions: intervention 1: Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel) intervention 2: Docetaxel 100 mg/m2 every 3 weeks in the comparator arm

Protocol document: