Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091168
Recruitment Status : Completed
First Posted : March 23, 2010
Last Update Posted : October 13, 2016
Information provided by (Responsible Party):
Pierre Fabre Medicament

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastases Drug: vinflunine Drug: alkylating agent of physician choice registered in cancer Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 594 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: arm A: 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

Primary Outcome Measures :
  1. Overall survival [ Time Frame: monthly for 6 months after disease progression and then every 3 months ]

Secondary Outcome Measures :
  1. Quality of life questionnaire [ Time Frame: every 6 weeks ]
  2. Adverse event profile [ Time Frame: monthly ]
  3. Tumour response rate [ Time Frame: every 6 weeks until disease progression ]
  4. Progression free survival [ Time Frame: every 6 weeks until disease progression ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091168

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Sponsors and Collaborators
Pierre Fabre Medicament

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pierre Fabre Medicament Identifier: NCT01091168     History of Changes
Other Study ID Numbers: L00070 IN 308 B0
First Posted: March 23, 2010    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Alkylating Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action