Metastatic breast cancer MedDRA version: 11.0 Level: LLT Classification code 10055113 Term:
Conditions
Interventions
Product Name: JAVLOR®
Product Code: L0070
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Vinflunine ditartrate
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must give written informed consent (personally signed and dated) before completing any study-related procedure 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 Patients may have received ixabepilone in countries where the drug has been registered. 6. Patients must be no longer candidate for anthracycline, taxane, antimetabolite and vinca-alkaloïd (except vinflunine) due to at least one of the following reasons: - resistance to the drug defined as disease progression while on therapy or progression within 4 months of receiving last dose in the metastatic setting. Only for anthracycline and taxane, a patient will also be considered as resistant if she relapsed within 12 months of last dose when given in the adjuvant or neoadjuvant setting. - intolerance to the drug defined as the occurrence of severe myelotoxicity (febrile neutropenia, neutropenic infection, grade 4 neutropenia requiring G-CSF support, grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring platelet transfusion) and/or the occurrence of grade = 3 non-haematological toxicity and / or the occurrence of grade 2 non-haematological toxicity lasting 14 days or more during one cycle of the drug, - only for anthracycline, minimum cumulative dose of 180 mg/m2 for doxorubicin or 300 mg/m2 for epirubicin. 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. Patients with Her-2 positive tumours may have been treated with anti-Her 2 targeted therapy (trastuzumab, lapatinib) and must have discontinued at least 4 weeks prior to randomisation 10. 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 > or = 12 weeks 13. WHO performance status or = 18 years and or = 1.5 x 109/l, platelets >or = 100 x 109/L, haemoglobin >or = 10g/dl 16. Adequate hepatic function : transaminases or = 50 ml/min 18. Women of childbearing potential must be using a medically accepted method of contraception (barrier methods, intrauterine devices) to avoid pregnancy during the 2 months preceding t
Exclusion criteria
Exclusion criteria: 1. Patients with pulmonary lymphangitis or symptomatic pleural effusion (grade >or = 2) that results in pulmonary dysfunction requiring active treatment 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 bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years previously with no evidence of recurrence 7. Patients with pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade > 1 8. History of severe hypersensitivity to vinca-alkaloids and/or alkylating agents or any contra indication to the study drugs 9. Known history of HIV infection 10. Pregnant or breast feeding women 11. Patients who have any serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia, congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction within 6 months prior to randomisation 12. Prior history of high-dose chemotherapy with bone marrow transplantation or autologous stem cell infusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Primary end point(s): The primary efficacy endpoint will be overall survival defined as the time from randomisation to death or last follow-up. | — |
Countries
Austria, Belgium, Bulgaria, France, Germany, Hungary, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed