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Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
Pierre Fabre Medicament Identifier:
First received: March 24, 2010
Last updated: October 30, 2015
Last verified: April 2014
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 Intervention Phase
Breast Cancer Drug: Vinflunine plus Capecitabine Drug: Capecitabine Phase 3

Study Type: Interventional
Study Design: 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.

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 ]

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 2 cycles (6 weeks) ]

Enrollment: 770
Study Start Date: May 2009
Study Completion Date: October 2015
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
  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.

Please refer to this study by its identifier: NCT01095003

  Show 111 Study Locations
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

Responsible Party: Pierre Fabre Medicament Identifier: NCT01095003     History of Changes
Other Study ID Numbers: L00070 IN 305 B0
2008-004171-21 ( EudraCT Number )
Study First Received: March 24, 2010
Last Updated: October 30, 2015

Additional relevant MeSH terms:
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 processed this record on August 18, 2017