NL-OMON45049招募中3 期
Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 study - TRAIN-2
BOOG Study Center (onderzoeksgroep zonder winstoogmerk)0 个研究点目标入组 430 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 430
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
- 18 至 99（—）
入选标准
- •1. Histologically confirmed infiltrating breast cancer.
- •2. Stage II or III disease.
- •3. Overexpression and/or amplification of HER2 in an invasive component of the core biopsy. Definitions see protocol page 14.
- •4. Age >=18
- •5. ECOG Group performance status <=1
- •6. LVEF >=50% measured by echocardiography, MUGA or MRI
- •7. No evidence of a concurrent contralateral or ipsilateral second primary infiltrating breast cancer.
排除标准
- •1. Previous radiation therapy or chemotherapy
- •2. Pregnancy, breast feeding
- •3. Evidence of distant metastases
- •4. Evidence of bilateral infiltrating breast cancer
- •5. Concurrent anti-cancer treatment or another investigational drug.
研究者
相似试验
进行中（未招募）
不适用
Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 studyBreast cancer, HER2 positive, stage II or IIIMedDRA version: 18.1Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-001863-21-NLBOOG Study Center
进行中（未招募）
1 期
PREDIX HER2 - preoperative treatment of HER2 positive breast cancerPrimary breast cancerMedDRA version: 20.0Level: PTClassification code: 10006201Term: Breast cancer stage III Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10006188Term: Breast cancer female NOS Class: 10029104MedDRA version: 20.0Level: PTClassification code: 10006200Term: Breast cancer stage II Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10006191Term: Breast cancer male NOS Class: 10029104CTIS2023-508411-23-00Karolinska University Hospital200
进行中（未招募）
1 期
PREDIX HER2 - preoperative treatment of HER2 positive breast cancerEUCTR2014-000808-10-SEKarolinska University Hospital200
进行中（未招募）
3 期
Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2HER2 PositiveBreast CancerNCT01996267The Netherlands Cancer Institute437
进行中（未招募）
1 期
De-Escalation of neoadjuvant ChemotheRapy in HER2-positive, EStrogen reCEptor-negative, Node-negative early breast cancer patients who achieved pathological complete response after neoadjuvant chemotherapy and Dual HER2 blOckadeHER2-positive, estrogen receptor (ER)-negative/progesterone receptor (PR)-negative, node-negative early breast cancerMedDRA version: 23.0Level: PTClassification code 10065430Term: HER2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-002918-41-BEInstitut Jules Bordet1,065