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NCT Number: NCT07084519

Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

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)

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Reconstruction Neoplasms Neoplasms by Site Radiation Oncology Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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 status: Recruiting

Location contact

Shulian Wang, MD

CONTACT

[email protected]

8810-87787659

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Prior radiotherapy to chest wall or nodal regions
  • Pregnancy or lactation
  • T4 stage disease
  • Autologous breast reconstruction of the irradiated breast
  • 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

Treatment and study plan

Hypofractionated radiotherapy

Radiation

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

Conventional fractionated radiotherapy

Radiation

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

Primary outcomes

  1. Reconstruction Failure Rate

    Time frame: 2 year

    implant removal, capsular contracture ≥ Baker grade III

Secondary outcomes

  1. Other Implant-Related Adverse Events

    Time frame: 2 year

    infection, skin necrosis, implant exposure

  2. Radiation-Related Toxicities

    Time frame: 2 year

    grade ≥3 dermatitis, pneumonitis, lymphedema

  3. DFS

    Time frame: 5 year

    Disease-Free Survival

  4. OS

    Time frame: 5 year

    Overall Survival

  5. LRR

    Time frame: 5 year

    Locoregional Recurrence Rate

  6. DM

    Time frame: 5 year

    Distant Metastasis Rate

  7. Cosmetic Outcome Assessed by Harvard Breast Cosmesis Scale (Physician-Rated)

    Time frame: 1 year

    Physicians will assess cosmetic outcome using the Harvard Breast Cosmesis Scale.

    Unit of Measure: Score on Harvard Breast Cosmesis Scale Scale Information: Score range from 1 (Excellent) to 4 (Poor). Higher scores indicate worse cosmetic outcomes.

  8. Patient-Reported Cosmetic Outcome

    Time frame: 1 year

    Description: Patients will self-assess cosmetic outcome using a 4-point Likert scale.

    Unit of Measure: Score on 4-point Likert scale. Scale Information: Score range from 1 (Excellent) to 4 (Poor). Higher scores indicate worse perceived outcome.

  9. Quality of Life Assessed by BREAST-Q (Breast Reconstruction Module), Version 2.0

    Time frame: Baseline, 6 months, and 12 months after treatment

    The BREAST-Q (Breast Reconstruction Module), Version 2.0 will be used to evaluate patients' global health status and overall quality of life.

    Unit of Measure: Score on a scale Scale Information: Score ranges from 0 to 100; higher scores indicate better global health status.

  10. Quality of Life Assessed by EORTC QLQ-BR23 Breast Cancer Module

    Time frame: Baseline, 6 months, and 12 months after treatment

    The EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23) will be used to assess breast cancer-specific quality of life.

    Unit of Measure: Score on a scale Scale Information: Score ranges from 0 to 100. For functional scales, higher scores indicate better function; for symptom scales, higher scores indicate worse symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Xuran Zhao, MD

CONTACT

[email protected]

86-13661135602

Yirui Zhai, MD

CONTACT

[email protected]

86-18610168510

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Randomized Controlled Trial of Postmastectomy Hypofractionated Radiotherapy Versus Conventional Fractionated Radiotherapy in Breast Cancer Patients Undergoing Prosthetic Breast Reconstruction

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 24, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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