Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Recruiting
CT.gov ID
NCT03961880
Collaborator
(none)
250
Enrollment
1
Location
52
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official 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
    Actual Study Start Date :
    Mar 1, 2019
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

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

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

      age in years

    3. Correlation of the RS with tumor nodal status [1 year]

    4. Correlation of the RS with tumor grading [1 year]

    5. Correlation of the RS with proliferation marker Ki-67 [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department for Women's Health Tübingen BW Germany 72086

    Sponsors and Collaborators

    • University Hospital Tuebingen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT03961880
    Other Study ID Numbers:
    • IRMA
    First Posted:
    May 23, 2019
    Last Update Posted:
    Jun 23, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Recurrence

    Study Results

    No Results Posted as of Jun 23, 2021