Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,936
- 试验地点
- 2
- 主要终点
- Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11
研究概览
简要总结
Trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.
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
- •Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
- •Histologically confirmed unilateral primary invasive carcinoma of the breast
- •Clinical T1 - T4 (except inflammatory breast cancer)
- •All clinical N (cN)
- •No clinical evidence for distant metastasis (M0)
- •Known HR status and HER2 status (local pathology)
- •Tumor block available for central pathology review
- •Performance Status ECOG <= 1 or KI >= 80%
- •Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
- •Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
- •The patient must be accessible for treatment and follow-up
- •Additional Inclusion criteria for patients receiving chemotherapy:
- •Laboratory requirements for patients receiving neoadjuvant chemotherapy (within 14 days prior to induction treatment):
- •Leucocytes >= 3.5 x 10^9/L
- •Platelets >= 100 x 10^9/L
- •Hemoglobin >= 10 g/dL
- •Total bilirubin <= 1 x ULN
- •ASAT (SGOT) and ALAT (SGPT) <= 2.5 x UNL
- •Creatinine <= 175 µmol/L (2 mg/dl)
- •LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment)
排除标准
- •Known hypersensitivity reaction to the compounds or incorporated substances
- •Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
- •Non-operable breast cancer including inflammatory breast cancer
- •Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
- •Concurrent treatment with other experimental drugs. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry
- •Male breast cancer
- •Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
- •Breast feeding woman
- •Sequential breast cancer
- •Reasons indicating risk of poor compliance
- •Patients not able to consent
- •Additional Exclusion Criteria for patients receiving chemotherapy:
- •Known polyneuropathy ≥ grade 2
- •Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease
- •Uncompensated cardiac function
- •Inadequate organ function including:
- •Leucocytes < 3.5 x 10^9/l
- •Platelets < 100 x 10^9/l
- •Bilirubin above normal limits
- •Alkaline phosphatase >= 5 x UNL
- •ASAT and/or ALAT associated with AP > 2.5 x UNL
研究组 & 干预措施
Anthracycline - Taxane
Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
干预措施: Epirubicin (Drug)
Anthracycline - Taxane
Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
干预措施: Cyclophosphamide (Drug)
Anthracycline - Taxane
Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
干预措施: Docetaxel (Drug)
Anthracycline - Taxane
Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
干预措施: Paclitaxel (Drug)
Taxane - Anthracycline
Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
干预措施: Epirubicin (Drug)
Taxane - Anthracycline
Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
干预措施: Cyclophosphamide (Drug)
Taxane - Anthracycline
Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
干预措施: Docetaxel (Drug)
Taxane - Anthracycline
Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11
时间窗: 3 Years
次要结局
- Overall survival(3 Years)