Prospective assessment of the clinical outcome of patients with primary breast cancer who have been tested with the EndoPredict gene expression test - a prospective care research study (RESCUE, Reaching for Evidence-baSed Chemotherapy Use in Endocrine Sensitive Breast Cancer)
- Conditions
- C50Malignant neoplasm of breast
- Registration Number
- DRKS00014051
- Lead Sponsor
- OGGO e.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1191
Inclusion Criteria
1. Informed consent
2. Tested with EndoPredict within the previous 6 months before inclusion
3. Patients with primary invasive breast cancer, Stage I/II
4. ER-postive
5. HER2-negative
6. N0 or N1 (1-3 positive lymph nodes)
7. T1-T3
Exclusion Criteria
1. Inflammatory breast cancer
2. Bilateral breast cancer
3. Breast cancer in the last 10 years
4. Other invasive malignancies in the last 5 years
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To show that female patients who have been tested as „low risk by EndoPredict (EPclin) and have been treated with endocrine therapy only for at least 5 years have a 10-year distant metastasis-free survival (DMFS) > 90 % (lower boundary of the one-sided 95 % confidence interval)
- Secondary Outcome Measures
Name Time Method