Phase III trial of IV vinflunine versus an alkylating agent in patients with metastatic breast cancer previously treated with or resistant to an anthracycline, a taxane, an antimetabolite, and a vinca-alkaloid - ND

• Conditions: Metastatic breast cancer; MedDRA version: 12.0Level: LLTClassification code 10055113Term: Breast cancer metastatic

• Registration Number: EUCTR2009-011118-47-IT
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-06
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 586

Inclusion Criteria

1. Patients must give written informed consent. 2. Women with histologically or cytologically confirmed carcinoma of the breast 3. Documented metastatic disease not amenable to curative surgery or radiotherapy 4. Patients must have received at least two and no more than five prior chemotherapy regimens given for the treatment of locally recurrent and/or metastatic disease, excluding chemotherapy received in the neo/adjuvant setting 5. Prior treatments must have included an anthracycline, a taxane, an antimetabolite and a vinca-alkaloid (except vinflunine) in any combination or order. 6. Patients must be no longer candidate for anthracycline, taxane, antimetabolite and vinca-alkalo?d (except vinflunine) due to at least one of the following reasons: resistance or intolerance to the drug. 7. Patients must have received their last dose of vinca-alkaloid more than 4 months before randomisation 8. Patients may have been treated with anti-cancer hormonal therapy but are no longer considered candidate for hormone therapy 9. Prior radiation therapy is allowed and must be completed at least 4 weeks before randomisation 11. Measurable or non measurable disease 12. Estimated life expectancy > 12 weeks 13. Age > 18 years and < 75 years 14. Adequate haematological, renal and hepatic function. 15. Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with pulmonary lymphangitis or symptomatic pleural effusion. 2. Patients with meningeal carcinomatosis 3. Patients with central nervous system metastases unless the patient has completed local therapy, is stable for at least 4 weeks by CT-scan without evidence of cerebral oedema and has no requirement for corticosteroids or anticonvulsivants 4. Patients having received any other experimental or anti-cancer therapy within 30 days before randomisation except hormone therapy 5. Patients who participated in a prior vinflunine clinical trial 6. History of second primary malignancy, except see protocol. 7. Patients with pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade > 1 8. Known history of HIV infection 9. Pregnant or breast feeding women 10. Patients who have any serious, concurrent uncontrolled medical disorder. 11. Prior history of high-dose chemotherapy with bone marrow transplantation or autologous stem cell infusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the overall survival in patients treated with i.v. vinflunine versus those receiving an alkylating agent of physician?s choice.;Secondary Objective: To compare between the 2 arms, 1) the progression-free survival, 2) the response rate and the disease control rate, 3) the duration of response and the disease control duration, 4) the time to response, 5) the overall safety, 6) the impact of both treatments on the health-related quality of life through a QoL questionnaire.;Primary end point(s): The primary efficacy endpoint will be overall survival defined as the time from randomisation to death or last follow-up.