Impact of Recurrence Score on Adjuvant Treatment Decisions in Breast Cancer Patients

University Hospital Tuebingen

Status: Completed

Conditions: Breast Cancer Female

Study type: Observational

Funder types: Other

Identifiers

NCT03961880

IRMA

Details and patient eligibility

About

IRMA is a Prospective, monocenter, non-interventional investigator initiated (IIT) registry that aims to investigate the use of the CE-marked OncotypeDX and its impact on adjuvant therapy recommendations in the clinical routine. Additionally, the proportion of patients with low, intermediate and high RS in predefined clinical subgroups will be determined. To evaluate the impact of the RS on tumor cell dissemination, these subgroups also include DTC-negative versus DTC-positive patients.

Enrollment: 270 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)