A Phase III Trial of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant.
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-079-10
- Lead Sponsor
- PIERRE FABRE MEDICAMENT,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 0
• 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 <30% of the bone marrow and must have ended at least 4 weeks before randomization (Appendix 10).
• Patients with a measurable or non-measurable disease according to the revised RECIST criteria (version 1.1) (Eisenhauer E, 2009).
• Good recovery after recent surgery. It must have been at least one week from a minor surgeon and 3 weeks from major surgery.
• Estimated life expectancy> 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 <1.5 x upper limit of normal (LSN), TGO and TGP <2.5 x LSN or <5 x LSN in case of liver metastases, alkaline phosphatase <5 x LSN ( in the 7 days prior to the first administration of the treatment under study).
• Adequate renal function, defined by creatinine clearance calculated> 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
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method