Clinical Trials Directory

Trials / Unknown

UnknownNCT06010615

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

Status
Unknown
Phase
Study type
Observational
Enrollment
70 (estimated)
Sponsor
Centre Hospitalier Universitaire de Besancon · Academic / Other
Sex
Female
Age
75 Years
Healthy volunteers
Not accepted

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 the investigators 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.

Conditions

Timeline

Start date
2023-09-20
Primary completion
2025-06-20
Completion
2025-06-20
First posted
2023-08-24
Last updated
2023-09-07

Source: ClinicalTrials.gov record NCT06010615. Inclusion in this directory is not an endorsement.