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NCT Number: NCT03961880

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

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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department for Women's Health

Tübingen, Baden-Wurttemberg, 72086, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Evaluation of the influence of the 21-gene Recurrence-Score (RS) on adjuvant therapy recommendation

    Time frame: 1 year

    The Recurrence Score is a continuous score that provides an individual estimate of the 10 year risk of distant recurrence and predicts the likelihood of benefit from chemotherapy. The quantitative nature of PCR allows for a continuous score as opposed to a binary result (low vs. high only). Oncotype DX test results assign a Recurrence Score - a number between 0 and 100 - to the early-stage breast cancer or DCIS.

    Recurrence Score lower than 18: The cancer has a low risk of recurrence. The benefit of chemotherapy is likely to be small and will not outweigh the risks of side effects.

    Recurrence Score of 18 up to and including 30: The cancer has an intermediate risk of recurrence. It's unclear whether the benefits of chemotherapy outweigh the risks of side effects.

    Recurrence Score greater than or equal to 31: The cancer has a high risk of recurrence, and the benefits of chemotherapy are likely to be greater than the risks of side effects.

Secondary outcomes

  1. Evaluation of the association of the RS with tumor cell dissemination into bone marrow

    Time frame: 1 year

    Bone marrow sampling is performed during primary surgery as part of the clinical routine. The presence of disseminated tumor cells (DTC status) is evaluated by immunostaining.

  2. Correlation of the RS with age

    Time frame: 1 year

    age in years

  3. Correlation of the RS with tumor nodal status

    Time frame: 1 year

  4. Correlation of the RS with tumor grading

    Time frame: 1 year

  5. Correlation of the RS with proliferation marker Ki-67

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Impact of Recurrence Score on Adjuvant Treatment Decisions and Tumor Cell Dissemination in Estrogen-receptor Positive and HER2 Negative Patients With Early Breast Cancer

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 23, 2019
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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