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BREASTOLD: Relative Dose Intensity of Adjuvant Chemotherapy in Older Women With ER+ HER2- Breast Cancer.

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06010615
Collaborator
(none)
70
Enrollment
22
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Localized breast cancers are defined as high-risk when they include lymph node involvement, Ki67 >30%, vascular emboli, low hormone receptor expression, or an unfavorable genomic signature result.

Under these conditions, sequential adjuvant chemotherapy with taxanes and anthracyclines is recommended.

Patients over 75 years of age receiving adjuvant chemotherapy are at greater risk of side-effects, which may necessitate dose reductions and a reduction in the intensity of chemotherapy. For curative adjuvant treatment, it is recommended to maintain a relative dose intensity (RDI) > 85%. A few publications have demonstrated the prognostic impact of a relative dose intensity < 85% for patients aged over 65. For several years now, the need for a specific assessment of elderly patients has been emphasized, prior to initiating oncological treatment (G8 score, onco-geriatric consultation).

This study is a retrospective descriptive study of patients aged over 75 treated with adjuvant chemotherapy from 01/01/2012 to 01/01/2020 for RH+ HER2 - breast cancer in Franche Comté.

Thus we wish to identify patients at risk of receiving sub-optimal relative dose intensity, in order to guide early and targeted supportive care or geriatric co-management interventions.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Relative Dose Intensity of Adjuvant Chemotherapy in Older Women With ER+ HER2- Breast Cancer.
    Anticipated Study Start Date :
    Aug 20, 2023
    Anticipated Primary Completion Date :
    Jun 20, 2025
    Anticipated Study Completion Date :
    Jun 20, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients receiving relative dose intensity (RDI) <85% [01/01/2012 to 31/12/2019]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women aged 75 or over

    • Patient with localized RH+HER2- breast cancer

    • Patient treated with adjuvant chemotherapy in Franche Comté between January 2012 and December 2019

    Exclusion Criteria:

    • Age < 75

    • Patient with metastatic breast cancer

    • Patient who received neoadjuvant chemotherapy

    • HER2+ breast cancer patient

    • Breast cancer patient with missing or negative hormonal status

    • Patient with localized recurrence of breast cancer with indication for new adjuvant therapy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT06010615
    Other Study ID Numbers:
    • 2023/785
    First Posted:
    Aug 24, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Aug 24, 2023