A clinical trial to compare the effects of two chemotherapy regimens (vinflunine plus capecitabine versus capecitabine alone) in patients with advanced breast cancer.

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 - L00070 IN 305 B0

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000607

Enrollment

764

Registered

2009-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Vinflunine plus Capecitabine: Vinflunine at the dose of 280 mg/m&sup2

on day 1 of each cycle every 3 weeks, over a 20-minute i.v. infusion. Plus Capecitabine at the dose of 825 mg/m&sup2

twice daily per os for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest. A cycle of therapy is defined as a 3 weeks period. Control Intervention1: Capecitabine: Capecit

twice daily per os for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest. A cycle of therapy is defined as a 3 weeks period.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients must give written informed consent 2. Women with confirmed carcinoma of the breast. 3. Patients must have received a minimum cumulative dose of anthracycline or be resistant to an anthracycline 4. Patients must be resistant to taxane therapy

Exclusion criteria

Exclusion criteria: 1.Patients having received > 3 regimens of chemotherapy 2.Prior therapy with capecitabine and/or vinca alkaloids (including vinflunine).

Design outcomes

Primary

Measure	Time frame
To compare the progression free survival between the 2 treatment arms (vinflunine combined with capecitabine versus capecitabine alone). Timepoint:  Analysis of PFS is planned to take place when 615 progressions or deaths have been observed or analysis at 6 months following the last patient accrued whichever occur first	—

Secondary

Measure	Time frame
To evaluate the safety and efficacy of vinflunine + capecitabine in comparison with capecitabine alone between the 2 arms. To assess the impact of both treatments in the Health-related quality of life through a QoL questionnaire. Timepoint: final analysis at 6 months following the last patient accrued or analysis of survival at when 631 patients death have died whichever occur first	—

Countries

Argentina, Belarus, Belgium, Brazil, Bulgaria, Chile, Czech Republic, Estonia, France, Hungary, India, Italy, Peru, Poland, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom

Contacts

Public ContactSandeep Adsule

Country Manager-Clinical Research

rajeev.chavda@pierre-fabre.com91-22-40621706

Outcome results