EUCTR2006-001139-23-DE进行中（未招募）不适用
Phase III study of vinflunine plus gemcitabine versus paclitaxel plus gemcitabine in patients with unresectable, locally recurrent or metastatic breast cancer after prior anthracycline-based adjuvant chemotherapy
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 994
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Patient must given written informed consent (personnaly dated and signed)
- •- Age between 18 and 75 years old
- •- Woman with histologically or cytologically confirmed carcinoma of the breast
- •- Woman of chilbearing potential must be using a medically accepted method of contraception to avoid pregancy 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. Woman of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first treatment administration
- •-Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy.
- •- Patient with eiter HER-2 negative disease assessed by IHC 0-1+ or FISH/CISH negative, on the primary tumour or on metastatic site, or HER-2 status unknown, provided that a tumour sample is available for retrospective review, if relevant.
- •- Patient must have received a prior neo-adjuvant and/or adjuvant anthracycline based chemotherapy ( or if contraindicated, a non-anthracycline based chemotherapy) with or without a taxane. The disease free interval from completion of the prior chemotherapy must be more than 12 months.
- •- Prior hormone therapy is allowed either in the neoadjuvant and/or adjuvant setting and in the metastatic setting provided that there is a documented progression of the disease ant the treatment must be terminated prior to randomisation.
- •- Prior radiation therapy allowed to inferior25% of the bone marrow and must be completed at least 4 weeks before randomisation.
- •- Patient with measurable or non-measurable lesion usong the RECIST guidelines.
- •- Estimated life expectancy superior or equal to 12 weeks.
- •- Karnofsky performance score > or = 70%
- •- Adequate haematological function (within 7 days before first study treatment): ANC >or=1,5 x 109/L, platelet count >or =100 x 109/L and haemaglobin >or=10 g/dL.
- •- Adequate hepatic function (within 7 days before first study treatment): Total bilirubin - Adequate renal function (within 7 days before first treatment administration): creatinine level within normal values or, in case of creatinine level > ULN, calculated creatinine clearance >or= 60 mL/min according to Cockroft-Gault formula.
- •- ECG without clinically relevant modification (within 7 days before first treatment administration).
- •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
排除标准
- •- Patient having received previous chemotherapy for metastatic disease or having progressed while on adjuvant chemotherapy or within 12 months from completion of adjuvant chemotherapy.
- •- Patient with known or with clinical evidence of brain metastatic or leptomeningeal involment.
- •- Inflammatory breast cancer without evidence of metastatic disease.
- •- Patient having received any other experimental or anti-cancer therapy within 30 days before randomisation, except hormone therapy
- •- History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, or other malignancy treated at least 5 years previously with no evidence of recurrence.
- •- Patient having as the sole tumour lesion, any of the following: malignant effusion, lymphangitis, cystic lesion, bone lesion and any other lesion that is not assessed by imaging techniques or colour photography.
- •- Patient with pre-existing motor or sensory peripheral neuropathy of CTCAE version 3.0 grade >1.
- •- History of severe hypersensitivity to vinca alkaloids and/or gemcitabine and/or taxanes or any contraindication to any of the study drugs.
- •- Pregnant or breast feeding woman.
- •- Patient who had a 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.
- •- Prior bone marrow transplantation or autologous stem cell infusion following high-dose chemotherapy.
- •- Prior therapy with gemcitabine and/or vinca alkaloids.
- •- Patients with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; and under guardianship (e. g. individuals who are not able to freely give their informed consent). These conditions should be assessed with the patient before randomisation.
研究者
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