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Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer

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. Identifier: NCT01095003
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : November 2, 2015
Information provided by (Responsible Party):
Pierre Fabre Medicament

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Vinflunine plus Capecitabine Drug: Capecitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Vinflunine plus Capecitabine Drug: Vinflunine plus Capecitabine

Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks

Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Active Comparator: Capecitabine single-agent Drug: Capecitabine
Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Every 6 weeks ]

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

  4. Quality of Life [ Time Frame: Every 2 cycles (6 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • female patients
  • 21 years of age or older
  • histologically/cytologically confirmed carcinoma of the breast
  • documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy
  • either one, two or three prior chemotherapy regimens
  • prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs
  • measurable or non-measurable disease according to RECIST 1.1
  • Karnofsky performance score of at least 70 %
  • adequate haematological, hepatic and renal functions
  • ECG without clinically relevant abnormality

Exclusion Criteria:

  • known or clinical evidence of brain metastasis or leptomeningeal involvement
  • pulmonary lymphangitis or symptomatic pleural effusion
  • any serious, concurrent uncontrolled medical disorder
  • history of second primary malignancy
  • preexisting motor/sensory peripheral neuropathy
  • known history of HIV infection
  • prior therapy with capecitabine and/or vinca-alkaloids
  • history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs
  • known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
  • pregnancy or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01095003

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Sponsors and Collaborators
Pierre Fabre Medicament

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pierre Fabre Medicament Identifier: NCT01095003     History of Changes
Other Study ID Numbers: L00070 IN 305 B0
2008-004171-21 ( EudraCT Number )
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: April 2014

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators