Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Vinflunine plus Capecitabine; Capecitabine
Intervention description: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks
Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks; Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Intervention MeSH terms: Capecitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 770.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No

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.
    

Eligibility 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