A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer (VICTORIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT02054338
First received: January 31, 2014
Last updated: February 3, 2014
Last verified: January 2014
  Purpose

The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to paclitaxel and gemcitabine is based on the following points: the significant antitumour activity of vinflunine in metastatic breast cancer (MBC) as single agent after anthracycline-taxane exposure and recent phase I study results of the vinflunine plus gemcitabine is at least additive and both drugs have a distinct mechanism of action; since taxanes have been approved in the adjuvant setting and are widely used in the treatment of early breast cancer it is worthwhile to assess new combination chemotherapy regimens as first line therapy for metastatic breast cancer.


Condition Intervention Phase
Advanced Breast Cancer
Drug: vinflunine 320 mg/m² as a 20-minute infusion on day 1 of each cycle repeated every 3 weeks gemcitabine 1000 mg/m² IV on day 1 and 8 repeated every 3 weeks
Drug: vinflunine plus gemcitabine
Drug: paclitaxel plus gemcitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer After Prior Anthracycline-based Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Every 6 weeks until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Every 6 months after disease progression ] [ Designated as safety issue: No ]
  • Overall Response Rate & Disease Control Rate [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Adverse event profile [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
    Collection and grading of reported adverse events and laboratory abnormalities

  • Quality of Life [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 1004
Study Start Date: June 2006
Study Completion Date: April 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vinflunine plus gemcitabine
vinflunine 320 mg/m² D1 plus gemcitabine 1000 mg/m2 D1 and D8 every 3 weeks
Drug: vinflunine 320 mg/m² as a 20-minute infusion on day 1 of each cycle repeated every 3 weeks gemcitabine 1000 mg/m² IV on day 1 and 8 repeated every 3 weeks Drug: vinflunine plus gemcitabine
320 mg/m² IV on day 1 plus gemcitabine 1000 mg/m² on days 1 and 8 of each cycle repeated every 3 weeks
Active Comparator: paclitaxel plus gemcitabine
paclitaxel 175 mg/m² D1 followed by Gemcitabine 1250 mg/m² D1 and D8 every 3 weeks
Drug: paclitaxel plus gemcitabine
paclitaxel 175 mg/m² on day 1 plus gemcitabine 1250 mg/m² on days 1

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients
  • 18 years or older but less than 75 years old
  • histologically/cytologically confirmed breast cancer
  • documented locally recurrent or metastatic breast cancer
  • HER-2 negative or unknown
  • prior neo- and/or adjuvant anthracycline-based chemotherapy
  • measurable or non-measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0
  • adequate haematological, hepatic and renal functions
  • ECG without any clinically relevant abnormality

Exclusion Criteria:

  • known or clinical evidence of brain metastases or leptomeningeal involvement
  • history of second primary malignancy
  • patients having as sole tumour lesion: malignant effusion, lymphangitis, cystic lesion, bone lesion, and any other lesion not assessed by imaging techniques or colour photography
  • pre-existing motor/ensory grade > 1 peripheral neuropathy
  • prior therapy with vinca alkaloids and/or gemcitabine
  • history of severe hypersensitivity to vinca alkaloids and/or gemcitabine or contraindication to any of these drugs
  • pregnancy or breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT02054338     History of Changes
Other Study ID Numbers: L00070 IN 303 B0, 2006-001139-23
Study First Received: January 31, 2014
Last Updated: February 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Belgium: Federal Agency for Medicinal Products and Health Products
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: Federal Commission for Protection Against Health Risks
Brazil: National Health Surveillance Agency
South Africa: Medicines Control Council
India: Drugs Controller General of India
Ukraine: State Pharmacological Center - Ministry of Health
Russia: Ministry of Health of the Russian Federation
Czech Republic: State Institute for Drug Control
Austria: Austrian Medicines and Medical Devices Agency
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Paclitaxel
Vinblastine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 26, 2014