Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy.

The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery

Intraoperative Radiotherapy (IORT)

Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery

Breast conservative surgery

A External Beam Hypofractionated Radiotherapy will be administered after surgery. y. The dose per fraction will be 2.67 Gy per session. EBRT will be performed daily from Monday to Friday for fifteen fractions.

External Beam Hypofractionated Radiotherapy (EBRT)

Evelyn Martínez, MD

To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy

To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy

Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial

It will be measured by the BCCT.core software programme. This software uses 4 photographies of the breast for each timepoint and evaluates cosmetic outcome based upon symmetry, skin colour changes and surgical scar appearance. The lower the calculated score, the better the cosmetic outcome (1=excellent, 2=good, 3=fair, 4=poor)

Questionnaire for cosmetic self-evaluation from the Young Boost Trial (YBT) that consists s of 8 questions about various aspects (size, shape, skin colour, massiveness of the breast, nipple position, general appearance, visibility of the surgical scar, and overall satisfaction) to evaluate the degree of satisfaction of the patients themselves about the cosmetic results.

It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30

Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast

It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-BR23

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy	NCT05498311	Breast Cancer	Intraoperative ... Breast conserva... External Beam H...	45 Years -	Institut Català d'Oncologia
Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy	NCT05498311	Breast Cancer	Intraoperative ... Breast conserva... External Beam H...	45 Years -	Institut Català d'Oncologia

Spots Global Cancer Trial Database for external beam hypofractionated radiotherapy (ebrt)