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Phase III Randomized, Multi Center Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or f...

Update Il y a 4 ans
Reference: EUCTR2006-001267-33

Phase III Randomized, Multi Center Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

Woman Man

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Extract

To compare the progression-free survival (PFS) of subjects with advanced breast cancer receiving sunitinib malate at a starting dose of 37.5 mg orally once daily with that of capecitabine at a dose of 1250 or 1000 (in patients older than 65 years) mg/m2 twice a day for 2 consecutive weeks, followed by a 1-week rest period and given as 3 weeks cycles.

Inclusion criteria

  • Histologically or cytologically proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent

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