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Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01091168
First received: February 3, 2010
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

In metastatic breast cancer (MBC) patients who have already received anthracyclines, taxanes, antimetabolites and vinca-alkaloids and have developed drug resistance to these drugs, therapeutic options are very limited. Alkylating agents showed a modest activity in pretreated metastatic breast cancer. This phase III trial will compare the effectiveness and the safety profile of vinflunine to an alkylating agent of physician choice in MBC patients who have exhausted anthracyclines, taxanes, antimetabolites and vinca-alkaloids.


Condition Intervention Phase
Breast Cancer
Metastases
 Drug: vinflunine
Drug: alkylating agent of physician choice registered in cancer
 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:

U.S. FDA Resources

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Overall survival [ Time Frame: monthly for 6 months after disease progression and then every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life questionnaire [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • Adverse event profile [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • Tumour response rate [ Time Frame: every 6 weeks until disease progression ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: every 6 weeks until disease progression ] [ Designated as safety issue: No ]

Enrollment: 594
Study Start Date: September 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm A: Vinflunine
Drug:vinflunine
 Drug: vinflunine
280 mg/m2 on day 1 of each cycle every 3 weeks
Active Comparator: arm B: Alkylating agent of physician choice Drug: alkylating agent of physician choice registered in cancer
cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin

  Eligibility

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

Inclusion Criteria:(main conditions)

  • Female patients 18 to 75 years of age with metastatic breast cancer histologically/cytologically confirmed not amenable to curative surgery or radiotherapy and who have received at least two prior chemotherapy regimens including anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate for these drugs,
  • Karnofsky performance score of at least 70 %, adequate haematological, hepatic and renal functions and ECG without clinically relevant abnormality.

Exclusion Criteria:

  • Concurrent serious uncontrolled medical disorder,
  • known or clinical evidence of brain metastases or leptomeningeal involvement,
  • pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,
  • history of second primary malignancy,
  • HIV infection, preexisting neuropathy,
  • pregnancy or breast feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091168

  Show 81 Study Locations
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01091168     History of Changes
Other Study ID Numbers: L00070 IN 308 B0
Study First Received: February 3, 2010
Last Updated: November 22, 2011
Health Authority: Austria: Federal Office for Safety in Health Care
Russia: Ministry of Health of the Russian Federation
Germany: Federal Institute for Drugs and Medical Devices
Ukraine: State Pharmacological Center - Ministry of Health
Belarus: Ministry of Health
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: National Monitoring Centre for Clinical Trials - Ministry of Health
Portugal: National Authority for Drug and Health Products, I.P.
Spain: Agencia Espanõla de Medicamentos y Productos Sanitarios
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Switzerland: Swissmedic
Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Neoplastic Processes
Pathologic Processes
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013