Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Alkylating Agents; Vinblastine

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.