Health TrialsbyHealthPanel

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

ConditionsBreast CancerImplant Breast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant or lactating patients.

Prior history of breast cancer.

Bilateral breast cancer.

Prior radiotherapy to the ipsilateral chest wall or regional lymph node areas.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ConvRT

    Radiation

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

  • HypoRT

    Radiation

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

Treatment groups

534 Participants
are divided into 2 treatment groups
Group A: Conventionally fractionated radiotherapyActive comparator 1 intervention
Group B: Hypofractionated radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The rate of unplanned reoperation

Surgery performed to treat complications related to breast reconstruction.

Time frame
3 years

Secondary outcomes

1

Implant-Based Breast Reconstruction Complications

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

Time frame
3 years
2

Locoregional recurrence

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

Time frame
5 years
3

Distant metastasis

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

Time frame
5 years
4

Overall survival

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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