Per-operative radiotherapy for localized breast cancer in older women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial evaluates the feasibility and toxicity of using the PAPILLON +TM device for per-operative radiotherapy in patients with localized breast cancer who are 65 years or older. The study focuses on women with invasive ductal adenocarcinoma measuring 2 cm or less, and aims to determine the safety and effectiveness of this innovative treatment approach. Participants will be monitored for any adverse effects during the treatment process. The trial is multicentric and open for recruitment across specific locations in France.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient with invasive ductal adenocarcinoma \<=2cm, evaluate on all radiological exams;
* Women aged 65 years or older (patients 65 years of age in the year may be included);
* Grade 1 or 2 unifocal adenocarcinoma, all index KI67, positive HR, negative HER2 status;
* T0 or T1, N0 radio-clinic;
* Operable patient with breast volume compatible with conservative surgery;
* Patient with prior malignancy or other concurrent malignancies are eligible, including bilateral breast cancer
* Patients who have been made aware of the information sheet and have given their written signed informed consent;
* Patients benefitting from social health insurance coverage

Exclusion Criteria:

* Age less than 65 years (except if 65 years obtained during the year)
* Patient with an exclusive in situ carcinoma
* Patient with lymphatic invasion / peri-nerve involvement / vascular emboli
* Patient with a lobular adenocarcinoma
* Patient with metastatic disease
* Multifocal tumor
* Patient with grade 3 or N+ disease
* N1 proved by ultrasound guided
* patient unable to express her consent
* Patient deprived placed under the authority of a tutor
* Female patients who are pregnant or breastfeeding
* Vulnerable patient: as defined in article L1121-5 à -8

Where it's running

• Centre Antoine Lacassagne
  Nice, France Recruiting
• Pôle Santé République
  Clermont-Ferrand, France Not yet recruiting

Study contacts

• Study coordinator: Frédérique JACQUINOT
• Email: drci-promotion@nice.unicancer.fr
• Phone: 04 92 03 10 24

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.