Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction
Outcomes of Hypofractionated Versus Conventionally Fractionated Radiotherapy After Mastectomy and Implant-Based Reconstruction: A Prospective, Randomized Controlled, Non-Inferiority 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jinli Ma, MD, PhD
- Phone Number: +86-21-64175590
- Email: ma-jinli@outlook.com
Study Locations
-
-
-
Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Xiaofang Wang
- Phone Number: 86-21-64175590
- Email: xiaofang0708@yeah.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypofractionated radiotherapy
|
42.56Gy/16Fx, 2.66Gy/Fx, once daily |
|
Active Comparator: Conventionally fractionated radiotherapy
|
50Gy/25Fx, 2Gy/Fx, once daily |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of unplanned reoperation
Time Frame: 3 years
|
Surgery performed to treat complications related to breast reconstruction. |
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
3 years
|
|
Locoregional recurrence
Time Frame: 5 years
|
Locoregional recurrence is defined as the first documented recurrence in the ipsilateral chest wall or regional nodes. |
5 years
|
|
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. |
5 years
|
|
Overall survival
Time Frame: 5 years
|
Overall survival is the time from randomization to death from any cause. |
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDRT-BC020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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