A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer

• Status: Terminated
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to paclitaxel and gemcitabine is based on the following points: the significant antitumour activity of vinflunine in metastatic breast cancer (MBC) as single agent after anthracycline-taxane exposure and recent phase I study results of the vinflunine plus gemcitabine is at least additive and both drugs have a distinct mechanism of action; since taxanes have been approved in the adjuvant setting and are widely used in the treatment of early breast cancer it is worthwhile to assess new combination chemotherapy regimens as first line therapy for metastatic breast cancer.

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

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel; Vinblastine

Criteria

Inclusion Criteria:

• female patients

• 18 years or older but less than 75 years old

• histologically/cytologically confirmed breast cancer

• documented locally recurrent or metastatic breast cancer

• HER-2 negative or unknown

• prior neo- and/or adjuvant anthracycline-based chemotherapy

• measurable or non-measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0

• adequate haematological, hepatic and renal functions

• ECG without any clinically relevant abnormality

Exclusion Criteria:

• known or clinical evidence of brain metastases or leptomeningeal involvement

• history of second primary malignancy

• patients having as sole tumour lesion: malignant effusion, lymphangitis, cystic lesion, bone lesion, and any other lesion not assessed by imaging techniques or colour photography

• pre-existing motor/sensory grade > 1 peripheral neuropathy

• prior therapy with vinca alkaloids and/or gemcitabine

• history of severe hypersensitivity to vinca alkaloids and/or gemcitabine or contraindication to any of these drugs

• pregnancy or breast feeding