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)

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) - RESCUE/NOGGO-B3

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014051

Enrollment

1191

Registered

2018-04-09

Start date

2018-07-17

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50

Interventions

Group 1: Visit 1, Inclusion: - Informed consent - Medical history - Demographics - Result of EndoPredict Test - Status of menopause - Disease status - Tumor board decision - Planned anti-tumor-therapy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
(1) Assessment of DMFS (Distant Metastasis Free Survival), DFS (Disease Free Survival), OS (Overall Survival) at 3, 5 and 10 years of patients with EPclin “low risk” (or EP “low risk” [EP score 5 years) endocrine therapy (in all patients and separately for men and women). (12) Assessment of DMFS, DFS, OS after 10 years according to EPclin / EP risk class for patients who have received an endocrine therapy for 5 years vs. patients who received an extended endocrine therapy (> 5 years). (13) Assessment of the correlation and concordance between EPclin, that has been calculated with pT- and pN- data and the EPclin based on ciT and ciN-data (in all patients and separately for men and women).	—

Measure

Time frame

(1) Assessment of DMFS (Distant Metastasis Free Survival), DFS (Disease Free Survival), OS (Overall Survival) at 3, 5 and 10 years of patients with EPclin “low risk” (or EP “low risk” [EP score 5 years) endocrine therapy (in all patients and separately for men and women). (12) Assessment of DMFS, DFS, OS after 10 years according to EPclin / EP risk class for patients who have received an endocrine therapy for 5 years vs. patients who received an extended endocrine therapy (> 5 years). (13) Assessment of the correlation and concordance between EPclin, that has been calculated with pT- and pN- data and the EPclin based on ciT and ciN-data (in all patients and separately for men and women).

—

Countries

Germany, Switzerland

Contacts

Public ContactKatja Gnausch

NOGGO e.V.

katja.gnausch@noggo.de030 403 68 65 35

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 6, 2026