Impact of recurrence score on adjuvant treatment decisions and tumor cell dissemination in estrogen-receptor positive and HER2 negative patients with early breast cancer

Impact of recurrence score on adjuvant treatment decisions and tumor cell dissemination in estrogen-receptor positive and HER2 negative patients with early breast cancer - IRMA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00016897

Enrollment

250

Registered

2019-03-04

Start date

2019-03-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C50

Interventions

Group 1: The 21-gene Recurrence Score® (RS) is used to quantify the risk of distant recurrence and to predict the benefits of chemotherapy in patients with hormone receptor-positive and HER2-negative

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -women = 18 years of age -histologically proven unilateral primary non-metastatic invasive breast cancer -ER-/ or PR- positive and HER2-negative -N0-N1 (0-3 involved lymph-nodes). The nodal status may be evaluated clinically. -surgery or planed surgery at the Department of women’s health, Tuebingen -written informed consent into IRMA

Exclusion criteria

Exclusion criteria: -ER-negative -HER2-positive -> 3 involved lymph-nodes -bilateral breast cancer -preexisting cancer disease within the last 10 years -preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria) -primary systemic therapy -locally advanced, inoperable or metastatic breast cancer -pregnant or lactating patients -inadequate general condition (not fit for chemotherapy)

Design outcomes

Primary

Measure	Time frame
Evaluation of the influence of the 21-gene Recurrence-Score on adjuvant therapy recommendation	—

Secondary

Measure	Time frame
- Evaluation of the association of the RS with tumor cell dissemination into bone marrow - Evaluation of the RS in specific subgroups (nodal status, age, grading Ki67)	—

Countries

Germany

Contacts

Public ContactAndreas Hartkopf

Department für Frauengesundheit

andreas.hartkopf@med.uni-tuebingen.de070712982211

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026