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

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00016897
• Lead Sponsor: Forschungsinstitut für FrauengesundheitDepartment für Frauengesundheit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-04
• Study Completion: 2022-10-31
• Results First Posted: 2023-05-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 245

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

-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)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the influence of the 21-gene Recurrence-Score on adjuvant therapy recommendation

Secondary Outcome Measures

Name	Time	Method
-Evaluation of the association of the RS with tumor cell dissemination into bone marrow <br>-Evaluation of the RS in specific subgroups (nodal status, age, grading Ki67) <br>