Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant.

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

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Capecitabine; Vinblastine

Criteria

Inclusion Criteria:

• female patients

• 21 years of age or older

• histologically/cytologically confirmed carcinoma of the breast

• documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy

• either one, two or three prior chemotherapy regimens

• prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs

• measurable or non-measurable disease according to RECIST 1.1

• Karnofsky performance score of at least 70 %

• adequate haematological, hepatic and renal functions

• ECG without clinically relevant abnormality

Exclusion Criteria:

• known or clinical evidence of brain metastasis or leptomeningeal involvement

• pulmonary lymphangitis or symptomatic pleural effusion

• any serious, concurrent uncontrolled medical disorder

• history of second primary malignancy

• preexisting motor/sensory peripheral neuropathy

• known history of HIV infection

• prior therapy with capecitabine and/or vinca-alkaloids

• history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs

• known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency

• pregnancy or breast feeding