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

NCT05058196 | Completed

• 1 other identifier: UC-0107/1903
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Therapeutic de-escalation; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Patient's choice when de-escalation is proposed between whole breast radiotherapy (WBRT), Intra Operative Radiotherapy (IORT) or no radiotherapy (RT).

  Assess the rate for each strategy of treatment chosen (WBRT, IORT or no RT) (decision made) by the patient.

  At baseline

Secondary Outcomes (16)

• Final treatment received (WBRT, IORT or no RT)

  6 weeks maximum (two weeks after surgery)

• Reason for the therapeutic choice from the patient's point of view

  6 weeks maximum (two weeks after surgery)

• Encounter decision aid (EDA) rate of use

  At baseline

• Geriatric Core Dataset (G-CODE)

  At baseline

• Single Item Literacy Screener (SILS)

  At baseline

Study Arms (3)

Whole breast radiotherapy after surgery

OTHER

WBRT will be delivered at 50 Grays (2 Grays x 25 fractions), 5 days/week for 5 weeks after breast surgery

Radiation: Whole breast radiotherapy

Intra Operative Radiotherapy

OTHER

IORT will be delivered at a single dose of 20 grays to the tumor bed during breast surgery

Radiation: Intra Operative Radiotherapy

no radiotherapy

NO INTERVENTION

No radiotherapy will be administrated to the patients during or after breast surgery

Interventions

Whole breast radiotherapy RADIATION

Whole breast radiotherapy after surgery

Whole breast radiotherapy after surgery

Intra Operative Radiotherapy RADIATION

Intra Operative Radiotherapy

Intra Operative Radiotherapy

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient must have signed a written informed consent form prior to any study specific procedures; when the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor can confirm in writing the patient's consent
• Women ≥65 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Clinical stage I, newly diagnosed breast cancer; invasive unifocal HR+ HER2- T1N0 tumour, not lobular, without extensive intraductal component (EIC) (\<25% EIC on biopsy), without embolism on biopsy
• Eligible to surgery
• Eligible for both WBRT or IORT
• Chemotherapy treatment is possible if needed
• Able to respond to self-report questionnaires in French
• Affiliated to Social security System

You may not qualify if:

• Patient with recurrent breast cancer or inflammatory breast carcinoma
• Absolute contra-indication to whole-breast irradiation as determined by the referring physician
• Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study
• Patient enrolled in another therapeutic trial. Observational cohorts are accepted if the collection of data does not interfere with the current trial
• Person deprived of their liberty or under protective custody or guardianship.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Julien MANCINI, MD, PhD

  Equipe "Cancers Biomédecine & Société" (CANBIOS) UMR1252 SESSTIM, Institut Paoli Calmettes

  PRINCIPAL INVESTIGATOR

• Agnès TALLET, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: October 15, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)