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

NCT ID: NCT03961880

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
* primary systemic therapy
* locally advanced, inoperable or metastatic breast cancer
* pregnant or lactating patients
* inadequate general condition (not fit for chemotherapy)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department for Women's Health

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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IRMA

Identifier Type: -

Identifier Source: org_study_id

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