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Patient's Choice in the Reduction of Their Treatment in Women Over 65 Year With Breast Cancer

NCT05058196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-03-30

No results posted yet for this study

Summary

Standard treatment for women with early breast cancer (HR+, HER2-, T1N0) consists of the removal of the tumor from the breast by surgery with or without chemotherapy, followed by a whole-breast radiation therapy (usually one radiation treatment a day, five days a week, for 3 to 6 weeks)

In some cases, for elderly patients older than 65 years with other associated pathologies, therapeutic de-escalation might be proposed in order to reduce the radiation doses received. Two options can be considered:

* Intraoperative radiotherapy: radiation is delivered in a single dose directly to the tumor bed during the surgery.
* Radiotherapy omission

These three treatment options (whole-breast radiation therapy, Intraoperative radiotherapy or -Radiotherapy omission) have advantages and disadvantages. Intraoperative radiotherapy allows a targeted treatment and avoids several weeks of daily radiation. Radiotherapy omission prevents acute or late toxicities of the radiotherapy, as well as the constraints of daily travel over a period of 3 to 6 weeks.

The aim of this trial is to offer patients aged 65 and over with early breast cancer, after surgery, these three treatment options and to study the choice and experience of treatment by patients. This study will assess the reasons that prompted patients to choose one of the three treatment options, the impact of medical and personal characteristics on this choice and the experience of therapeutic de-escalation as well as its effects, in particular on the course of care.

This assessment will be carried out with self-administered questionnaires before and after the choice of treatment.

In addition, to standardize the information given to patients in order to support them in their treatment choice and promote patient involvement in treatment decision-making, an encounter decision aid will be available for the patients. This encounter will detail the advantages and disadvantages of the three treatment options and will help in discussions with the physicians to determine the best choice of treatment.

Conditions

Interventions

RADIATION

Whole breast radiotherapy

Whole breast radiotherapy after surgery

RADIATION

Intra Operative Radiotherapy

Intra Operative Radiotherapy

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Julien MANCINI, MD, PhD · Equipe "Cancers Biomédecine & Société" (CANBIOS) UMR1252 SESSTIM, Institut Paoli Calmettes

  • Agnès TALLET, MD · Institut Paoli-Calmettes

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-09-01
Completion
2025-10-15

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05058196 on ClinicalTrials.gov