TNM Trial: Upfront Docetaxel [T] and Alternating iv and Oral Vinorelbine [N] Followed, by Either Maintenance Oral Vinorelbine, or Observation for Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Time To Disease Progression of patients who are treated with Vinorelbine-Docetaxel followed by maintenance oral Vinorelbine vs patients treated with Vinorelbine-Docetaxel without maintenance treatment
研究概览
简要总结
This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel combination given as an initial upfront treatment (first line) to all metastatic breast cancer patients enrolled. Patients having a disease control following initial treatment, will be randomized to either oral Vinorelbine maintenance arm or Observation arm. The trial will also compare the efficacy and safety of maintenance oral Vinorelbine versus Observation.
详细描述
To our knowledge, this is the first trial evaluating the role of oral Vinorelbine as a maintenance therapy versus observation following a first line treatment with iv/oral Vinorelbine+Docetaxel. Eligible patients will be enrolled in the trial to receive 6 cycles of iv(D1)/oral(D8) Vinorelbine + Docetaxel. For responding and SD patients, after the 6 cycles, they will be randomized either in observation arm or to receive a maintenance chemotherapy with oral Vinorelbine. The oral form of the drug was found to be most appropriate for a long term treatment allowing to preserve QoL of the patients. Oral Vinorelbine will be administered on D1, D8 every 3 weeks during maintenance treatment, until PD, unacceptable toxicity or patient refusal to continue. The trial will assess efficacy/safety of initial Vinorelbine-Docetaxel combination as well as the benefits of maintenance chemotherapy with oral Vinorelbine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Patients >=18 years of age
- •Histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent
- •Measurable and/or non-measurable disease
- •The patient's primary and/or metastatic tumor is HER2 neu negative
- •Documented metastatic disease previously untreated with palliative chemotherapy
- •Adjuvant or neo-adjuvant chemotherapy (including treatment with docetaxel or any other chemotherapy) is allowed with a disease free survival of at least 6 months
- •No symptom or sign of brain metastasis
排除标准
- •Operable local recurrence
- •Ascites or pericardial effusion as only site of metastasis
- •Symptomatic peripheral neuropathy > grade 1 according to the NCI Common Toxicity Criteria
- •Radiotherapy to all areas of evaluable disease within the previous 4 weeks
- •Disease significantly affecting absorption
- •Severe hepatic insufficiency
- •Patient previously treated with chemotherapy for their metastatic disease
研究组 & 干预措施
Maintenance treatment
Initial treatment Vinorelbine-Docetaxel Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks for 6 cycles
Followed by:
Oral Vinorelbine 60mg/m2 D1, D8 or 80mg/m2 D1, D8 (dose schedule at investigator's discretion) Every 3 weeks until disease progression, unacceptable toxicities or patient refusal to continue
干预措施: Vinorelbine-Docetaxel (Drug)
Maintenance treatment
Initial treatment Vinorelbine-Docetaxel Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks for 6 cycles
Followed by:
Oral Vinorelbine 60mg/m2 D1, D8 or 80mg/m2 D1, D8 (dose schedule at investigator's discretion) Every 3 weeks until disease progression, unacceptable toxicities or patient refusal to continue
干预措施: Vinorelbine (Drug)
Observation arm
Initial treatment: Vinorelbine-Docetaxel Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks for 6 cycles
Patients in the observation arm will not be administered any treatment after Vinorelbine-Docetaxel
干预措施: Vinorelbine-Docetaxel (Drug)
结局指标
主要结局
Time To Disease Progression of patients who are treated with Vinorelbine-Docetaxel followed by maintenance oral Vinorelbine vs patients treated with Vinorelbine-Docetaxel without maintenance treatment
时间窗: Up to 36 months
次要结局
- Overall Response Rate(Up to 36 months)
- Duration of Response(Up to 36 months)
- Quality of Life(Up to 36 months)
- Number and percentage of participants with Adverse Events(Participants will be followed for the entired duration of the study, an expected average of 60 months)
- 3-Y Overall Survival(Up to 36 months)