Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Intraoperative Radiotherapy (IORT); Procedure: Breast conservative surgery; Radiation: External Beam Hypofractionated Radiotherapy (EBRT)

• Registration Number: NCT05498311
• Lead Sponsor: Institut Català d'Oncologia

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-10-20
• Study First Submitted: 2021-04-08
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-11
• Study First Posted: 2022-08-12
• Last Update Posted: 2022-08-15
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 89

Inclusion Criteria

• Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy.
• Not pregnant at diagnosis.
• Signed informed consent form.
• Age ≥45 years old.
• Patients candidates to Intrabeam.
• Patients with ≥60 years with the presence of one or more of the following adverse criteria after surgery:
• Tumor size > 2.5 cm.
• Extensive intraductal carcinoma (≥25%)
• Lymphovascular invasion.
• Involved focal margins (<2mm) without ampliation surgery.

Exclusion Criteria

• Presence of distant metastasis.
• Primary chemotherapy.
• Lymph node involvement.
• Negative hormonal receptors.
• Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas
• Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
• Uncontrolled infection.
• Concurrent treatment with other experimental treatments
• Lack of signed informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative Radiotherapy (IORT)	Breast conservative surgery	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.
Intraoperative Radiotherapy (IORT)	Intraoperative Radiotherapy (IORT)	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.
Intraoperative Radiotherapy (IORT)	External Beam Hypofractionated Radiotherapy (EBRT)	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.

Primary Outcome Measures

Name	Time	Method
Changes in Cosmetic results - BCCT	Baseline and every 12 months until 60 months	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)
Changes in Cosmetic results - Self Evaluation using YBT	Baseline and every 12 months until 60 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Quality of life (QOL) - General	Baseline and every 12 months until 60 months	It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30
Changes in Quality of life (QOL) - Breast	Baseline and every 12 months until 60 months	It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-BR23
Toxicity (acute and late)	Baseline and every 12 months until 60 months	Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Local control	Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years	Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast

Trial Locations

Locations (1)

Evelyn Martínez; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain