Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

NCT05498311 | Unknown Phase 2

• 1 other identifier: IORT BREAST CANCER
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Intraoperative radiotherapy; hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Changes in Quality of life (QOL) - General

  Baseline and every 12 months until 60 months

• Toxicity (acute and late)

  Baseline and every 12 months until 60 months

• Local control

  Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years

• Changes in Quality of life (QOL) - Breast

  Baseline and every 12 months until 60 months

Study Arms (1)

Intraoperative Radiotherapy (IORT)

EXPERIMENTAL

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); Procedure: Breast conservative surgery; Radiation: External Beam Hypofractionated Radiotherapy (EBRT)

Interventions

Intraoperative Radiotherapy (IORT) RADIATION

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

Intraoperative Radiotherapy (IORT)

Breast conservative surgery PROCEDURE

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

Intraoperative Radiotherapy (IORT)

External Beam Hypofractionated Radiotherapy (EBRT) RADIATION

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.

Intraoperative Radiotherapy (IORT)

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead

Study Sites (1)

Evelyn Martínez

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Evelyn Martínez, MD

  Institut Català d'Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Martínez, MD

CONTACT

+34 93 260 77 20; emperez@iconcologia.net

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: Intraoperative Radiotherapy (IORT)

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: August 12, 2022
• Study Start: October 20, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

ES (1)