Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

NCT07084519 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: NCC5419
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction. Study Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction. Intervention: HFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)

Conditions

Breast Cancer; Breast Reconstruction; Radiation Oncology

Keywords

breast cancer; prosthetic breast reconstruction; hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• Reconstruction Failure Rate

  implant removal, capsular contracture ≥ Baker grade III

  2 year

Secondary Outcomes (10)

• Other Implant-Related Adverse Events

  2 year

• Radiation-Related Toxicities

  2 year

• DFS

  5 year

• OS

  5 year

• LRR

  5 year

Study Arms (2)

HFRT group

EXPERIMENTAL

43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)

Radiation: hypofractionated radiotherapy

CFRT group

OTHER

50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks

Radiation: conventional fractionated radiotherapy

Interventions

hypofractionated radiotherapy RADIATION

43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)

HFRT group

conventional fractionated radiotherapy RADIATION

50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks

CFRT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, aged 18-75 years
• Karnofsky Performance Status ≥60
• Histopathologically confirmed invasive breast adenocarcinoma
• Total mastectomy \[with or without nipple-areolar complex preservation\] + axillary dissection/sentinel lymph node biopsy + implant/expander placement R0 resection with negative margins
• pT3 or N2-3 disease; or pT1-2N1
• No distant metastasis
• Completed standard neoadjuvant/adjuvant chemotherapy cycles
• ≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy
• Signed informed consent

You may not qualify if:

• Prior radiotherapy to chest wall or nodal regions
• Pregnancy or lactation
• T4 stage disease
• Pre-radiotherapy local/regional/distant metastasis
• Grade ≥3 implant-related adverse events irreversible before radiotherapy
• Bilateral breast cancer requiring bilateral radiotherapy
• Concurrent/secondary malignancy with disease-free interval \<5 years \[except non-melanoma skin cancer, papillary/follicular thyroid cancer, or cervical carcinoma in situ\]
• Active collagen vascular disease, e.g., SLE, scleroderma
• Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Province, 10000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Central Study Contacts

Xuran Zhao, MD

CONTACT

86-13661135602; 923791362@qq.com

Yirui Zhai, MD

CONTACT

86-18610168510; januarywind@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of radiation oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 24, 2025
• Study Start: August 10, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)