Reducing the number chemotherapy cycles based on radiologic tumor response in HER2-positive breast cancer: the TRAIN-3 study (BOOG 2018-01)
- Conditions
- HER2-positive, stage II/III breast cancerMedDRA version: 20.0 Level: PT Classification code 10006200 Term: Breast cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10006201 Term: Breast cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 20.0 Level: PT Classification code 10075653 Term: HER2 gene amplification System Organ Class: 10018065 - General disorders and administration site conditions
- Registration Number
- EUCTR2018-003275-35-NL
- Lead Sponsor
- BOOG Study Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 462
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.
4. Age <:18
5. ECOG Group performance status
6. LVEF >50% measured by echocardiography, MRI or MUGA
7. Known HR-status ( in percentages)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 462
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 462
1. Previous chemotherapy
2. Pregnancy or breastfeeding
3. Evidence of distant metastases
4. Evidence of bilateraal infiltrating breast cancer
5. Concurrent anti-cancer treatment or another investigational drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method