EUCTR2009-017485-23-AT进行中（未招募）1 期
TRastuzumab in HER2-negative Early breast cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) (Treat CTC trial)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 1,317
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
入选标准
- •? Female gender
- •? Age = 18 years
- •? Written informed consent must be given according to ICH/GCP, and national/local regulations
- •? Availability of peripheral blood draw for CTC blood test
- •? Tumor block or minimum 10 unstained slides of 10 µm of primary tumor must be available prior to registration for centralized HER2 testing
- •? ER status available
- •? Adequately excised non-metastatic and non-relapsed operable primary invasive HER2-negative adeno-carcinoma of the breast that is all of the following*:
- •? Histological Grade > 1 at time of surgery and primary tumor size > 1 cm
- •? the patient should have completed either
- •? adjuvant chemotherapy or
- •? neoadjuvant chemotherapy; in this case residual invasive disease in breast or lymph nodes is required (no complete pathological response)
- •? No further adjuvant chemotherapy treatment planned. Prior chemotherapy with doxorubicin restricted to a total dose of 360 mg/m2 or with epirubicin restricted to a total dose of 720 mg/m2 is allowed
- •? No prior use of anti-HER2 therapy for any reason or other prior use of biological agent or immunotherapy for BC
- •? No prior and or concomitant use of bisphosphonate therapy for any reason
- •? No prior mediastinal irradiation except internal mammary node irradiation for the present BC
- •? Concomitant adjuvant hormonal therapy or radiotherapy (if applicable) is allowed upon physician’s choice
- •? The interval between definitive surgery (neoadjuvant population) or end of adjuvant chemotherapy (adjuvant population) and registration must be at least 3 weeks but no more than 12 weeks
- •? No evidence of unresolved or unstable toxicity from prior surgery, adjuvant chemotherapy or radiotherapy
- •? No history of prior (ipsilateral and/or contralateral) invasive breast carcinoma or ductal carcinoma in situ, except for the BC proposed in this study. Bilateral breast cancer is acceptable if both tumors are HER2- negative and have been diagnosed within 2 years from registration
- •? No history of any malignant neoplasms in the past 5 years except for curatively treated basal and squamous cell carcinoma of the skin
- •? No prior autologous or allogeneic stem cell transplantation
- •? No history of serious cardiac illness or medical conditions, including but not confined to:
- •? History of documented congestive heart failure
- •? High risk uncontrolled arrhythmias
- •? Angina pectoris requiring anti-anginal medication
- •? Clinically significant valvular heart disease
- •? Evidence of transmural infarction on ECG
- •? Poorly controlled hypertension (e.g. systolic > 180 mm Hg or diastolic > 100 mm Hg)
- •? No history of other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions
- •? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration
- •? No concurrent participation in another tr
排除标准
- •Please see inclusion criteria
研究者
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