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

Nanjing Medical University

Status: Enrolling

Conditions: Breast Cancer

Treatments: Radiation: Hypofractionated Radiation Therapy; Radiation: Conventional fraction radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06830083

First Affiliated Hospital, Nan

Details and patient eligibility

About

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.

Full 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.

Enrollment: 840 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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840 participants in 2 patient groups

conventional fraction radiotherapy

Active Comparator group

Description:

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.

Treatment:

Radiation: Conventional fraction radiotherapy

hypofractioned radiotherapy

Experimental group

Description:

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.

Treatment:

Radiation: Hypofractionated Radiation Therapy