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

Tracking Information
First Received Date ^ICMJE	February 3, 2010
Last Updated Date	November 22, 2011
Start Date ^ICMJE	September 2009
Estimated Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 19, 2010)	Overall survival [ Time Frame: monthly for 6 months after disease progression and then every 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01091168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 19, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Breast Cancer Metastases
Intervention ^ICMJE	Drug: vinflunine 280 mg/m2 on day 1 of each cycle every 3 weeks Drug: alkylating agent of physician choice registered in cancer cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin
Study Arm (s)	Experimental: arm A: Vinflunine Drug:vinflunine Intervention: Drug: vinflunine Active Comparator: arm B: Alkylating agent of physician choice Intervention: Drug: alkylating agent of physician choice registered in cancer
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	594
Estimated Completion Date	August 2012
Estimated Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Argentina, Austria, Belarus, Belgium, France, Germany, Italy, Portugal, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01091168
Other Study ID Numbers ^ICMJE	L00070 IN 308 B0
Has Data Monitoring Committee	Yes
Responsible Party	Pierre Fabre Medicament
Study Sponsor ^ICMJE	Pierre Fabre Medicament
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Pierre Fabre Medicament
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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