This trial is active, not recruiting.

Conditions breast cancer, metastases
Treatments vinflunine, alkylating agent of physician choice registered in cancer
Phase phase 3
Sponsor Pierre Fabre Medicament
Start date September 2009
End date January 2013
Trial size 594 participants
Trial identifier NCT01091168, L00070 IN 308 B0


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
280 mg/m2 on day 1 of each cycle every 3 weeks
(Active Comparator)
alkylating agent of physician choice registered in cancer
cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin

Primary Outcomes

Overall survival
time frame: monthly for 6 months after disease progression and then every 3 months

Secondary Outcomes

Quality of life questionnaire
time frame: every 6 weeks
Adverse event profile
time frame: monthly
Tumour response rate
time frame: every 6 weeks until disease progression
Progression free survival
time frame: every 6 weeks until disease progression

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Pierre Fabre Medicament.