Hypofractionated Radiation Fractionation in Breast Cancer Patients with Implant-Based Reconstruction (HFIBR)

February 11, 2025 updated by: Sun Xinchen, The First Affiliated Hospital with Nanjing Medical University
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. The investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with breast cancer frequently have requirement for breast reconstruction after mastectomy. For patients with limited autologous tissue availability, implant-based reconstruction remains an effective alternative. Due to the absence of high-level evidence, collaborative efforts between surgical and radiation oncology teams are advised to determine the optimal sequencing and techniques for integrating reconstruction surgery with radiotherapy. The ongoing Alliance A221505 and FABREC phase III randomized controlled trials are comparing the incidence of reconstructive complications following hypofractionated and conventional fractionation radiotherapy. FABREC trial recently showed the hypofractionated regimen did not significantly improve change in physical well-being（PWB), domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life assessment tool, compared with the conventional fractionation radiotherapy. This trial added to the increasing experience with HF PMRT in patients with implant-based reconstruction.

In 2019, the European Society for Radiotherapy and Oncology (ESTRO) provided guidelines for target delineation based on the position of the implant in breast reconstruction to minimize the irradiation of normal tissues. Existing studies on the risk of complications from irradiating expanders and implants have yielded inconsistent conclusions, with each approach having its own advantages and disadvantages.

Our study aims to compare the incidence of reconstructive complications between hypofractionated and conventional fractionation radiotherapy after implant-based reconstruction surgery to provide high-level evidence for medium-dose hypofractionated radiotherapy after immediate implant-based reconstructive surgery.

Study Type

Interventional

Enrollment (Estimated)

840

Phase

  • Not Applicable

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

  • Name: Jiangsu Province People's Hospital
  • Phone Number: 86-025-68307676
  • Email: 13770662828@163.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province People's Hospital/The First Affiliated with Nanjing Medical University
        • Contact:

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

No

Description

Inclusion Criteria:

1. Pathological diagnosis of stage I-III breast cancer (non-T4), >18 years old; 2. Complete breast cancer resection (including skin-sparing and nipple-sparing total resection) 3. According to the guidelines of the Chinese Anticancer Society, postoperative adjuvant radiotherapy is required; 4. Undergo immediate reconstructive surgery (tissue dilator or permanent implant)

Exclusion Criteria:

  1. Auto-reconstruction surgery
  2. Clinical or pathological T4
  3. Both sides need radiotherapy
  4. Have a history of chest radiotherapy
  5. Pregnancy/lactation
  6. Participate in other drug clinical trials

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional fraction radiotherapy
Total dose of plan tumor volume is 5000 cGy，and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes.
Radiation: Conventional fraction radiotherapy
Total dose of plan tumor volume is 5000 cGy，and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the supraclavicular (with or without axillary) lymph nodes.
Other Names:
  • CF
Experimental: hypofractioned radiotherapy
Total dose of plan tumor volume is 4050 cGy，and each fraction will consist of 270 cGy per day. 15 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes.
Radiation: Hypofractionated Radiation Therapy
Hypofractionation regimen: Total dose to the chest wall and the regional lymph nodes is 4050 cGy, and each fraction consists of 270 cGy per day(daily, Monday through Friday )
Other Names:
  • HF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major complication
Time Frame: From enrollment to the end of treatment at 24 months
implant related complications requiring reoperation such as severe necrosis，severe infections, severe capsular contracture, implant rupture and implant exposure.
From enrollment to the end of treatment at 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any breast-related complications
Time Frame: From enrollment to the end of treatment at 24 months
Complications included infections, wound dehiscence, skin flap necrosis, implant exposure, capsular contracture, seroma, and hematoma.
From enrollment to the end of treatment at 24 months
Absolute reconstruction failure
Time Frame: From enrollment to the end of treatment at 24 months
From enrollment to the end of treatment at 24 months
Oncologic outcomes
Time Frame: From enrollment to the end of treatment at 5 years
local-regional recurrence free survival
From enrollment to the end of treatment at 5 years
Cosmetic outcomes
Time Frame: From enrollment to the end of treatment at 24 months
satisfaction with breast and physical and psychosocial well-bing after radiotherapy will be assessed from baseline to 24 months by trained physicians using Breast-Q Version 2.0© Reconstruction Module Scales Chinese (CN) Version .
From enrollment to the end of treatment at 24 months

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Hunan Cancer Hospital
Jiangsu Taizhou People's Hospital

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)

January 30, 2025

Primary Completion (Estimated)

December 30, 2030

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • First Affiliated Hospital, Nan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Breast Cancer

Clinical Trials on Conventional fraction radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe