Actively Recruiting

Age: 65Years +
FEMALE
ID04282122

Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity for Women 65 and Older

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-02-12

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating ways to personalize radiotherapy for women aged 65 and older with early-stage, luminal A breast cancer who have had breast-conserving surgery. The study focuses on using the NovaGray Breast® test, a rapid radiosensitivity assay that measures radiation-induced CD8 T-lymphocyte apoptosis (RILA) along with clinical factors to predict the risk of late toxicities such as breast fibrosis and poor cosmetic outcomes that affect quality of life. The goal is to improve treatment decisions by considering individual radiosensitivity. The study observes different radiotherapy approaches including whole breast hypofractionation, volume reduction techniques like intraoperative radiotherapy (IORT), brachytherapy, and external partial breast irradiation. It also considers omission of radiotherapy in select low-risk cases. The NovaGray Breast® test guides these personalized treatment choices to potentially reduce severe breast fibrosis and other side effects. Participants will be followed for up to five years to monitor acute and late breast fibrosis rates and quality of life using the EORTC QLQ-C30 questionnaire. The study includes regular clinical evaluations and uses the radiosensitivity test results to inform radiotherapy decisions. This prospective evaluation aims to integrate individual radiosensitivity testing into routine clinical practice for better patient outcomes.

CONDITIONS

Brief Title

Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity

Who Can Participate

Age: 65Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 65 years or older
  • Have undergone breast-conserving surgery for breast cancer
  • Diagnosed with T1-T2 tumors, sentinel node negative or N0
  • Luminal A tumor subtype
  • Tumor margins are negative
  • Indicated for whole breast irradiation only
  • No evidence of distant metastases (M0)
  • Able to attend follow-up visits
  • Provided written and dated informed consent
  • Affiliated with the French social security system
Not Eligible

You will not qualify if you...

  • Presence of distant metastases
  • Need for node irradiation
  • Synchronous bilateral breast cancer
  • Treated by radical mastectomy
  • Received neoadjuvant therapy
  • Other malignancies within past 3 years except treated basal or squamous cell skin cancer or in situ cervical carcinoma
  • Unstable or untreated serious non-cancer systemic diseases
  • Use of systemic investigational drugs within past 30 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Radiotherapy

Duration - Approximately 3 to 6 weeks

Participants undergo curative-intent radiotherapy to treat breast cancer.

Daily visits, 5 days a week

Long-term Monitoring

Duration - Up to 5 years

Participants are followed for acute and late breast fibrosis and quality of life for up to 5 years after radiotherapy.

Periodic follow-up visits over 5 years

Trial Site Locations

Total: 1 location

1

Institut Régional du Cancer de Montpellier

Montpellier, Occ, France, 34298

Actively Recruiting

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Research Team

J

Jean-Pierre BLEUSE, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Frequently Asked Questions

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Published Research Related To This Trial

Impact of adjuvant hormonotherapy on radiation-induced breast fibrosis according to the individual radiosensitivity: results of a multicenter prospective French trial.

Céline Bourgier, Florence Castan, Olivier Riou...

https://pubmed.ncbi.nlm.nih.gov/29644007

CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients.

Mahmut Ozsahin, Nigel E A Crompton, Sophie Gourgou...

https://pubmed.ncbi.nlm.nih.gov/16243816

Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial.

Jayant S Vaidya, Frederik Wenz, Max Bulsara...

https://pubmed.ncbi.nlm.nih.gov/24224997

5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial.

Vratislav Strnad, Oliver J Ott, Guido Hildebrandt...

https://pubmed.ncbi.nlm.nih.gov/26494415

Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy.

Ivo A Olivotto, Timothy J Whelan, Sameer Parpia...

https://pubmed.ncbi.nlm.nih.gov/23835717

Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a randomised controlled trial.

Ian H Kunkler, Linda J Williams, Wilma J L Jack...

https://pubmed.ncbi.nlm.nih.gov/25637340

The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials.

Joanne S Haviland, J Roger Owen, John A Dewar...

https://pubmed.ncbi.nlm.nih.gov/24055415