To hear about similar clinical trials, please enter your email below
Trial Title:
Relative Dose Intensity of Adjuvant Chemotherapy in Older Women With ER+ HER2- Breast Cancer.
NCT ID:
NCT06010615
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
Patients aged 75 and over with RH+ HER2- breast cancer who received adjuvant chemotherapy
between 01/01/2012 and 01/01/2020, within the Regional Cancer Network of
Bourgogne-Franche-Comté - oncoBFC
Sampling method:
Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
75 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 20, 2023
Completion date:
June 20, 2025
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Besancon
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Besancon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06010615
