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

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06830083
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-26
• Study Start: 2025-01-30
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Primary Completion: 2030-12-30
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 840

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major complication	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.

Secondary Outcome Measures

Name	Time	Method
Any breast-related complications	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.
Absolute reconstruction failure	From enrollment to the end of treatment at 24 months
Oncologic outcomes	From enrollment to the end of treatment at 5 years	local-regional recurrence free survival
Cosmetic outcomes	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 .

Trial Locations

Locations (1)

Jiangsu Province People's Hospital/The First Affiliated with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China