Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01095003
First received: March 24, 2010
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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
Advanced Breast Cancer
Drug: Vinflunine plus Capecitabine
Drug: Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

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 ] [ 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 2 cycles (6 weeks) ] [ Designated as safety issue: No ]

Enrollment: 770
Study Start Date: May 2009
Estimated Study Completion Date: June 2014
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01095003

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

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01095003     History of Changes
Other Study ID Numbers: L00070 IN 305 B0, 2008-004171-21
Study First Received: March 24, 2010
Last Updated: April 17, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
Belarus: Ministry of Health
Estonia: The State Agency of Medicine
India: Drugs Controller General of India
Taiwan: Department of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Africa: Medicines Control Council
Italy: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Switzerland: Swissmedic
Belgium: Federal Agency for Medicinal Products and Health Products
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Mexico: Federal Commission for Protection Against Health Risks

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014