Conditions: Breast Neoplasms
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 442
Healthy volunteers: no

Brief summary:
The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sunitinib + Capecitabine intervention 2: Capecitabine
Intervention descriptions: intervention 1: Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen.

Capecitabine administered orally at a starting dose of 2000 mg/m\^2 per day \[1000 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. intervention 2: Capecitabine administered orally at a starting dose of 2500 mg/m\^2 per day \[1250 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.

Protocol document: