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

  • STATUS
    Recruiting
  • End date
    Jun 27, 2028
  • participants needed
    40
  • sponsor
    Centre Antoine Lacassagne
Updated on 27 July 2021

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.

Details
Condition Localized Breast Cancer
Treatment Per-Operative Radiotherapy technique by Papillon +TM
Clinical Study IdentifierNCT04680715
SponsorCentre Antoine Lacassagne
Last Modified on27 July 2021

Eligibility

Yes No Not Sure

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 -8
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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