Who is sponsoring NCT00435409?

NCT00435409 is sponsored by Pfizer.

What condition does NCT00435409 study?

NCT00435409 studies Breast Neoplasms.

What drugs are being tested in NCT00435409?

Interventions: Sunitinib + Capecitabine, Capecitabine.

What is the status of NCT00435409?

NCT00435409 is currently COMPLETED.

Last reviewed 2012-06-15 · How we verify

A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer

NCT00435409 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	Pfizer
Phase	Phase 3
Status	COMPLETED
Enrolment	442
Start date	2007-02
Completion	2011-06

Conditions

Breast Neoplasms

Interventions

Sunitinib + Capecitabine
Capecitabine

Primary outcomes

Progression Free Survival (PFS) — Baseline until disease progression (up to 3 years from first dose)
Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.

Countries

United States, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Poland, Romania, Russia, Spain, United Kingdom