Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy (IORT_BREAST)

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Intraoperative Radiotherapy (IORT); Procedure: Breast conservative surgery; Radiation: External Beam Hypofractionated Radiotherapy (EBRT)

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 Type: Interventional
• Enrollment (Anticipated): 89
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Evelyn Martínez, MD; Phone Number: +34 93 260 77 20; Email: emperez@iconcologia.net

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Recruiting
      • Evelyn Martínez
      • Contact: Evelyn Martínez, MD; Phone Number: +34 93 260 77 20; Email: emperez@iconcologia.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Radiation: Intraoperative Radiotherapy (IORT); The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery; Procedure: Breast conservative surgery; Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery; Radiation: External Beam Hypofractionated Radiotherapy (EBRT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Cosmetic results - BCCT	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)	Baseline and every 12 months until 60 months
Changes in Cosmetic results - Self Evaluation using YBT	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.	Baseline and every 12 months until 60 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut Català d'Oncologia
• Investigators: Principal Investigator: Evelyn Martínez, MD, Institut Catala d'Oncologia

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2016
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (ACTUAL): August 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: hypofractionated radiotherapy; Intraoperative radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IORT BREAST CANCER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No