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Recruiting

NCT Number: NCT07835139

Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction

This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients aged ≥ 18 years.
  • Pathologically confirmed unilateral primary invasive breast cancer.
  • Underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with axillary staging (sentinel lymph node biopsy or axillary lymph node dissection).
  • Underwent 1-stage (direct-to-implant) or 2-stage (tissue expander) reconstruction, or implant combined with autologous tissue, with prepectoral or subpectoral placement.
  • Received standard neoadjuvant or adjuvant systemic therapy (chemotherapy, endocrine, anti-HER2, or targeted therapy) according to guidelines or clinical trial protocols.
  • Definite indication for post-mastectomy chest wall ± regional nodal irradiation according to guidelines (typically c/pT1-3 N0-3 M0).
  • Interval of at least 6 weeks between reconstruction surgery and the initiation of radiotherapy.
  • ECOG performance status 0-1.
  • Prior non-breast malignancy permitted if disease-free for > 5 years with low recurrence risk; prior cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma permitted regardless of disease-free interval.
  • Estimated life expectancy ≥ 10 years.
  • Written informed consent provided.

Exclusion criteria

  • Pregnant or lactating patients.
  • Prior history of breast cancer.
  • Bilateral breast cancer.
  • Prior radiotherapy to the ipsilateral chest wall or regional lymph node areas.
  • T4 disease (including, but not limited to, inflammatory breast cancer, regardless of response to neoadjuvant systemic therapy).
  • Non-breast malignancy within the past 5 years (except cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma).
  • Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding radiotherapy tolerance or follow-up compliance.

Treatment and study plan

ConvRT

Radiation

50Gy/25Fx, 2Gy/Fx, once daily

HypoRT

Radiation

42.56Gy/16Fx, 2.66Gy/Fx, once daily

Primary outcomes

  1. The rate of unplanned reoperation

    Time frame: 3 years

    Surgery performed to treat complications related to breast reconstruction.

Secondary outcomes

  1. Implant-Based Breast Reconstruction Complications

    Time frame: 3 years

    Defined as adverse events following implant-based breast reconstruction, including reconstruction-related surgical complications and implant-specific complications.

  2. Locoregional recurrence

    Time frame: 5 years

    Locoregional recurrence is defined as the first documented recurrence in the ipsilateral chest wall or regional nodes.

  3. Distant metastasis

    Time frame: 5 years

    Distant metastasis is the first confirmed recurrence in any distant organ/site beyond the ipsilateral chest wall and regional nodes.

  4. Overall survival

    Time frame: 5 years

    Overall survival is the time from randomization to death from any cause.

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Outcomes of Hypofractionated Versus Conventionally Fractionated Radiotherapy After Mastectomy and Implant-Based Reconstruction: A Prospective, Randomized Controlled, Non-Inferiority Trial

Important dates

Study start
2026
Primary completion
2033
Study completion
2035
First posted
Sep 22, 2026
Registry last updated
Sep 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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