A Phase III Trial of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant.

NCT01095003 Phase 3 COMPLETED Results posted

The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant.

Details

Lead sponsor	Pierre Fabre Medicament
Phase	Phase 3
Status	COMPLETED
Enrolment	770
Start date	2009-05
Completion	2015-10

Conditions

• Breast Cancer

Interventions

• Vinflunine plus Capecitabine
• Capecitabine

Primary outcomes

• Progression Free Survival — Baseline up to 2 years 7 months
  PFS is defined as time from date of randomization to date of the first documentation of objective tumor progression (according to the Independent Response Review Committee (IRC) and based on RECIST version 1.1) or death due to any cause. The PFS was primarily analysed in the Intent-to-treat (ITT) population. Patients lost to follow-up, or without a known record of progression or death at time of analysis had the progression-free survival censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression, whichever occurs last.

Countries

Argentina, Belarus, Belgium, Brazil, Bulgaria, Czechia, Estonia, France, Hungary, India, Italy, Mexico, Poland, Russia, Serbia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom