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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02054338
First Posted: February 4, 2014
Last Update Posted: February 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pierre Fabre Medicament
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Every 6 months after disease progression ]
  • Overall Response Rate & Disease Control Rate [ Time Frame: Every 6 weeks ]
  • Adverse event profile [ Time Frame: Every 3 weeks ]
    Collection and grading of reported adverse events and laboratory abnormalities

  • Quality of Life [ Time Frame: Every 6 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
No Contacts or Locations Provided
  More Information

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT02054338     History of Changes
Other Study ID Numbers: L00070 IN 303 B0
2006-001139-23 ( EudraCT Number )
First Submitted: January 31, 2014
First Posted: February 4, 2014
Last Update Posted: February 4, 2014
Last Verified: January 2014

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


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