Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer - Full Text View

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine

U.S. FDA Resources

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:	April 2013
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

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 2, 2013
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 May 23, 2013