NCT03503799: RESCUE

Reaching for Evidence-baSed Chemotherapy Use in Endocrine Sensitive Breast Cancer

Active, enrolled Last updated 13 April 2026

What this trial tests

trial testing Observation in Primary Invasive Breast Cancer in 1,191 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 July 2018

Primary endpoint
1 October 2032

1 October 2032

Quick facts

Lead sponsor	North Eastern German Society of Gynaecological Oncology
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	1,191
Start date	17 July 2018
Primary completion	1 October 2032
Estimated completion	1 October 2032
Sites	40 locations across Switzerland, Germany

Drugs / interventions tested

• Observation

Conditions studied

• Primary Invasive Breast Cancer — all drugs for Primary Invasive Breast Cancer →
• Estrogen Receptor Positive Tumor — all drugs for Estrogen Receptor Positive Tumor →
• Human Epidermal Growth Factor Receptor 2 Negative Tumor — all drugs for Human Epidermal Growth Factor Receptor 2 Negative Tumor →

Sponsor

North Eastern German Society of Gynaecological Oncology

Who can join

18 and older, any sex, with Primary Invasive Breast Cancer or Estrogen Receptor Positive Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Systematic assessment of survival data of patients who have been tested with EndoPredict®; prospective proof that patients with low risk classification by EndoPredict® (EPclin) can safely forgo chemotherapy and be treated with endocrine therapy alone.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Using Breast Cancer Gene Expression Signatures in Clinical Practice: Unsolved Issues, Ongoing Trials and Future Perspectives.
   Varnier R, Sajous C, de Talhouet S, Smentek C, et al · · 2021 · cited 20× · PMID 34638325 · DOI 10.3390/cancers13194840
2. Gene Expression Profiling Tests for Early-Stage Invasive Breast Cancer: A Health Technology Assessment.
   Ontario Health (Quality) . · · 2020 · cited 19× · PMID 32284770
3. Gene Expression Profiling in Early Breast Cancer-Patient Stratification Based on Molecular and Tumor Microenvironment Features.
   Munkácsy G, Santarpia L, Győrffy B. · · 2022 · cited 14× · PMID 35203458 · DOI 10.3390/biomedicines10020248
4. Delineating intra-tumoral heterogeneity and tumor evolution in breast cancer using precision-based approaches.
   Xulu KR, Nweke EE, Augustine TN. · · 2023 · cited 7× · PMID 37662839 · DOI 10.3389/fgene.2023.1087432
5. Personalised medicine and the decision to withhold chemotherapy in early breast cancer with intermediate risk of recurrence - a systematic review and meta-analysis.
   Wallerstedt SM, Nilsson Ek A, Olofsson Bagge R, Kovács A, et al · · 2020 · cited 4× · PMID 32504183 · DOI 10.1007/s00228-020-02914-z
6. Breast cancer gene expression signatures: development and clinical significance-a narrative review.
   Li S, Yu X, Xu Y. · · 2023 · cited 2× · PMID 38751471 · DOI 10.21037/tbcr-22-39
7. Individualized Chemotherapy Benefit Prediction by EndoPredict in Patients With Early Breast Cancer in an Indian Cohort.
   Somashekhar SP, Zaveri S, Vijay DG, Dattatreya PS, et al · · 2020 · cited 2× · PMID 32897733 · DOI 10.1200/go.20.00250
8. Long-term prospective outcome data using EndoPredict as risk stratification and chemotherapy decision biomarker in hormone receptor-positive, HER2-negative early breast cancer.
   Klein E, Kiechle M, Josipovic A, Anders SI, et al · · 2024 · cited 1× · PMID 38722442 · DOI 10.1007/s10549-024-07346-2