None listed
Conditions
Interventions
Group 1 Type of group
Patients received (in combination with capecitabine) Vinflunine at the dose of 280 mg/m² and as a 20-minute IV. infusion on day 1 of each cycle repeated every 3 weeks.
Group name:Group 2 Type of group
Capecitabine at the dose of 825mg/m² per os twice per day each morning and each evening for 14 consecutive days beginning on day 1 of each cycle repeated every 3 weeks (self-administered).
Sponsors
PIERRE FABRE MEDICAMENT,
Eligibility
Sex/Gender
Female
Age
21 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Patients must give informed written consent (dated and signed personally) before performing any procedure related to the study that involves an assessment or evaluation that is not part of the patient´s normal medical care. • Women suffering from histologically or cytologically confirmed breast cancer. • Documented locally recurrent or metastatic disease not susceptible to surgery or radiotherapy with curative intent. • Patients must have received one, two or three previous chemotherapy regimens, including those administered in neoadjuvant or adjuvant. • Previous treatments must have included an anthracycline and a taxane. These drugs may have been administered alone or as part of a combination with another agent and may have been included in the same treatment regimen. These agents may have been administered in neoadjuvant / adjuvant or in metastatic disease or both. • Patients should have received a minimum cumulative dose of anthracycline (applies to> 180 mg / m2 of doxorubicin or> 300 mg / m2 of epirubicin) • Patients should be resistant to taxane treatment • Previous anti-neoplastic hormone therapy is allowed, but the patient can no longer be a candidate for subsequent hormonal therapy. The treatment must have ended 2 weeks before randomization. • Patients who have received a targeted anti-Her-2 therapy (eg trastuzumab, lapatinib), should have discontinued treatment at least 3 weeks before randomization. • Prior radiotherapy is allowed in 12 weeks. • Kamofsky functional status score> 70% (Appendix 2). • Age> 21 years. • Appropriate hematological function defined by absolute neutrophil count (RAN)> 1.5 x 10 ^ 9 / L, platelet count> 100 x 10 ^ 9 / L and hemoglobin> 10 g / dL (within 7 days prior to first administration of the treatment under study). • Adequate liver function, defined by: total bilirubin 50 mL / min, according to the Cockroft-Gault formula (ml / min) = [(0.85) (140-age) (weight)] / [ (0.81) (SrCr pmol / L)] (in the 7 days prior to the first administration of the treatment). 19. ECG without clinically important alterations (in the 7 days prior to the first administration of the treatment). • Patients who are following treatment with coumarin derivatives must have reached stable doses and have a standardized international ratio (INR) <3 at the time of selection. • Women of childbearing age should use a medically accepted contraceptive method (for example, barrCTa methods, intrauterine devices) to prevent pregnancy during the two months prior to the start of the study treatment, during the study period and up to three months later of the last dose of the treatment under study, so that the risk of pregnancy is minimized. Women of childbearing age should obtain a negative result in the b
Exclusion criteria
Exclusion criteria: • Patients with known brain metastases or leptomeningeal involvement or with clinical evidence. • Patients with pulmonary lymphangitis or symptomatic pleural effusion (grade> 2) that causes pulmonary dysfunction and requires active treatment. • Patients who have received any other experimental treatment or antineoplastic treatment within 30 days prior to randomization, with the exception of hormone therapy. • History of second primary malignant tumor, except: bilateral breast carcinoma, in situ carcinoma of the cervix, properly treated non-melanomatous cutaneous carcinoma or another malignant tumor treated, at least 5 years before without evidence of recurrence. • Patients with previous existence of peripheral motor or sensory neuropathy of grade> 1 according to the CTCAE version 3.0 criteria. • Patients who have received> 3 chemotherapy regimens. • Previous therapy with capecitabine and / or vinca alkaloids (including vintlunin). • History of severe hypersensitivity to vinca alkaloids and / or fluoropyrimidine or any contraindication to any of the drugs under study. • Known deficiency or suspected deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD). • Pregnant or breastfeeding women. • Positive pregnancy test at the time of inclusion. • Known history of HIV infection. • Inability to ingest and / or absorb oral medication, including previous gastric surgery or any evidence of obstruction of the small or large intestine, gastric obstruction, partial esophageal obstruction; gastrointestinal disorder that affects the absorption of capecitabine (malabsorption syndrome, 2/3 of gastric resection and intestinal resection). • Patients presenting with a serious uncontrolled concurrent medical disorder, especially uncontrolled hypercalcemia, congestive heart failure, uncontrolled high risk hypertension, arrhythmia, angjna of the chest or previous history of myocardial infarction in the 6 months prior to randomization. • Previous bone marrow transplant or autologous stem cell infusion after high-dose chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:PFS is defined as time from date of randomization to date of the first documentation of objective tumor progression (according to the Independent Response Review Committee (IRC) and based on RECIST version 1.1) or death due to any cause. The PFS was primarily analysed in the Intent-to-treat (ITT) population. Patients lost to follow-up, or without a known record of progression or death at time of analysis had the progression-free survival censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression, whichever occurs last. Measure:Progression Free Survival Timepoints:Baseline up to 2 years 7 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The overall survival (OS) was defined as the duration between the date of randomisation and the date of death from any cause. The OS analysis was performed in the ITT population and the eligible and per protocol populations once the required number of events (631 deaths) was observed Patients lost to follow-up, or without a known record of death at time of analysis had the OS censored at the date of last contact. Measure:Overall Survival Timepoints:Baseline upto 3 years 10 months ; Outcome name:ORR defined as documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. Measure:Overall Response Rate (ORR) Timepoints:Baseline upto 2 years 7 months ; Outcome name:Disease control rate defined (DCR) as the sum of confirmed complete response, confirmed partial response and stabilisation rate. Measure:Disease Control Rate Timepoints:Baseline up to 2 years 7 months ; Outcome name:Measured from the first time that measurement criteria were first met for objective response (documented CR or PR) until recurrence/progression or death whatever the cause. Measure:Duration of Response Timepoints:Baseline up to 2 years 7 months | — |
Countries
Austria, Bulgaria, Estonia, France, Germany, Hungaria, Italy, Peru, Portugal, Spain, United Kindgdom
Outcome results
None listed