JPRN-jRCT2080220464已完成3 期
ALTTO(Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) trial
ovartis Pharma K.K0 个研究点目标入组 8,000 人开始时间: 2007年11月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Age>=18 years
- •2. Eastern Cooperative Oncology Group (ECOG) performance status=<1;
- •3. Non-metastatic operable primary invasive adenocarcinoma of the breast fulfilling the following:
- •a. Histologically confirmed;
- •b. Adequately excised (exceptions: patients who have 'non-resectable' deep margin invasion are eligible provided they have had or will receive radiotherapy encompassing the region concerned; patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumour bed);
- •c. Axilla dissected; sentinel node sampling is allowed, provided that axillary dissection follows confirmation of a positive sentinel node; sentinel node sampling alone is NOT acceptable after neoadjuvant chemotherapy (in patients receiving neoadjuvant chemotherapy lymph node status will be considered unknown, regardless of the results of post-chemotherapy axillary dissection);
- •d. Axillary node positive patient OR node negative patient with a tumour greater than or equal to 1.0 cm in greatest diameter. For clarification, isolated tumour cells (ITC) are considered pN0 and micrometastases are considered pN1.
- •4. Known hormone receptor status (ER/PgR or ER alone);
- •5. For Designs 1 and 2: Patient must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen or listed as an exception in Table 5.
- •For Design 1: Randomisation must be performed no longer than 12 weeks from Day 1 of the last chemotherapy cycle after obtaining a post-chemotherapy LVEF >=50. Study treatment must start no more than 14 days after randomisation.
- •For Design 2: Randomisation must be performed no longer than 6 weeks from Day 1 of the last anthracycline-containing chemotherapy cycle after obtaining a post-anthracycline chemotherapy LVEF >=50. Study treatment must start no more than 14 days after randomisation and must be concurrent with taxanes.
- •For Design 2B: Randomisation must be performed no longer than 8 weeks from definitive surgery. Non-anthracycline platinum containing regimen (docetaxel and carboplatin) and study treatment must start concomitantly and no more than 14 days after randomisation.
排除标准
- •1. History of any prior (ipsi- and/or contralateral) invasive breast carcinoma;
- •2. Past (less than 10 years) or current history of malignant neoplasms, except for curatively treated 1) basal and squamous cell carcinoma of the skin or 2) carcinoma in situ of the cervix.
- •NOTE: Patients with a prior malignancy diagnosed greater than 10 years in the past who have been curatively treated with surgery ONLY, WITHOUT radiation therapy or systemic therapy (chemotherapy or endocrine) are eligible for the study. Patients with any prior diagnosis of invasive breast cancer or melanoma, at any time, are excluded from this study.
- •3. Any clinically staged T4 tumour, including inflammatory breast cancer;
- •4. Bilateral tumours;
研究者
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