Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer

NCT04680715 | Recruiting Phase 2 DMC

• 1 other identifier: 2020/33
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Phase II study; open recruitment, multicentrique. The aim of this clinical research is to evaluate faisability and toxicity of the per-operative radiotherapy using PAPILLON + TM device for localized breast cancers patients over 65 years.

Conditions

Localized Breast Cancer

Outcome Measures

Primary Outcomes (1)

• early toxicities occuring until 6 months after performing per-operative radiotherapy

  pourcentage of patient with toxicities of grade 3 and more (by CTCAE v5.0) related to per-operative radiotherapy and that occured until 6 months after performing

  up to 6 months

Secondary Outcomes (4)

• global tolerance of per-operative radiotherapy

  up to 5 years

• local disease free survival at 5 years of per-operative radiotherapy

  up to 5 years

• disease free survival at 5 years of per-operative radiotherapy

  up to 5 years

• quality of life of patients

  up to 6 months

Study Arms (1)

Per-Operative Radiotherapy technique by Papillon +TM

EXPERIMENTAL

Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM

Radiation: Per-Operative Radiotherapy technique by Papillon +TM

Interventions

Per-Operative Radiotherapy technique by Papillon +TM RADIATION

20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer

Per-Operative Radiotherapy technique by Papillon +TM

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (2)

Pôle Santé République

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

Central Study Contacts

Frédérique JACQUINOT

CONTACT

04 92 03 10 24; drci-promotion@nice.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: radiotherapy treatment

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 23, 2020
• Study Start: July 16, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)