External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients (ESIBIRE)

January 24, 2024 updated by: Silvia Takanen, Regina Elena Cancer Institute

A Prospective Phase II Trial of an Accelerated Hypofractionated Radiotherapy Schedule With Risk-adapted Simultaneous Integrated Boost (HF-SIB) in Early Breast Cancer Patients Undergoing Breast Conserving Surgery

This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00144
        • Recruiting
        • Regina Elena Cancer Institute
        • Contact:
        • Principal Investigator:
          • Silvia Takanen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Histologically proven invasive or in situ unifocal adenocarcinoma of the breast
  • Breast conserving surgery
  • Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells [i+] allowed) pN1mic, M0 stage
  • Postoperative negative (no ink) final surgical margins
  • Patient requires a whole breast radiotherapy plus a tumor bed boost
  • Female patients aged ≥ 18 years of any menopausal status
  • ECOG performance status 0-2

Exclusion Criteria:

  • Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free
  • Mastectomy
  • Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded)
  • Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma
  • Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder
  • Pregnant or lactating patients
  • Presence of ipsilateral breast implant
  • Prior breast or thoracic radiotherapy for any condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Simultaneous integrated boost to 40 Gy (SIB 40)

Patients with the following clinico-pathological characteristics

  • pTis G3,
  • pT1 pN0/pN1mic, G1-G3 luminal biology or Her-2 positive
Radiation: Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy
Other Names:
  • SIB40
Active Comparator: Simultaneous integrated boost to 43 Gy (SIB 43)

Patients with the following clinico-pathological characteristics:

  • Triple negative disease,
  • pT2 pN0/pN1mic,
  • ≤ 50 years not Luminal A
Radiation: Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy
Other Names:
  • SIB43

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale
Time Frame: From the end of treatment at 3 years
Incidence of grade 2-3 late toxicity in terms of skin toxicity
From the end of treatment at 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of local tumor relapse, distant metastasis and assessment of overall survival
Time Frame: Time from the date of the diagnosis of primary breast cancer to the date of diagnosis of local relapse, distant metastasis or death from any cause, assessed up to 60 months
Identification of local tumor relapse in the breast parenchyma within boost volume, breast parenchyma within volume receiving 34Gy; identification of distant metastasis and analysis of overall survival
Time from the date of the diagnosis of primary breast cancer to the date of diagnosis of local relapse, distant metastasis or death from any cause, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1652/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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