EUCTR2009-017485-23-BE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
排除标准
- •? Prior use of anti-HER2 therapy for any reason or immunotherapy for BC
- •? Prior mediastinal irradiation except internal mammary node irradiation for the present BC
- •? Evidence of unresolved or unstable toxicity from prior surgery, adjuvant chemotherapy or radiotherapy
- •? History of prior invasive breast carcinoma, except for the BC diagnosed and treated before entry. Unifocal or multifocal unilateral (one breast) or unifocal or multifocal synchronous bilateral breast cancer are acceptable if invasive tumor foci are HER2-negative. History of previous ductal carcinoma in situ is allowed.
- •? History of any malignant neoplasms in the past 5 years except for curatively treated basal and squamous cell carcinoma of the skin
- •? Prior autologous or allogeneic stem cell transplantation
- •? 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)
- •? History of other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions
- •? Presence 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.
- •? Concurrent participation in another trial
研究者
相似试验
进行中（未招募）
1 期
Trastuzuamb in HER-2 negative early breast cancer as added treatment after surgery for patients presenting CTC (Circulating Tumor Cells)HER2-Negative Early Breast CancerMedDRA version: 18.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-017485-23-GBEORTC1,317
进行中（未招募）
1 期
Trastuzuamb in HER-2 negative early breast cancer as added treatment after surgery for patients presenting CTC (Circulating Tumor Cells)EUCTR2009-017485-23-DEEORTC1,317
进行中（未招募）
1 期
Trastuzuamb in HER-2 negative early breast cancer as added treatment after surgery for patients presenting CTC (Circulating Tumor Cells)EUCTR2009-017485-23-FREORTC1,317
进行中（未招募）
1 期
Trastuzuamb in HER-2 negative early breast cancer as added treatment after surgery for patients presenting CTC (Circulating Tumor Cells)HER2-Negative Early Breast CancerMedDRA version: 16.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-017485-23-GREORTC1,317
进行中（未招募）
1 期
Trastuzuamb in HER-2 negative early breast cancer as added treatment after surgery for patients presenting CTC (Circulating Tumor Cells)HER2-Negative Early Breast CancerMedDRA version: 18.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-017485-23-ATEORTC1,317