Breast CancerNCT07835139
Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction
A study testing ConvRT and HypoRT in people with Breast Cancer and Implant Breast Reconstruction, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Implant Breast Reconstruction
- What is being tested?
- ConvRT and HypoRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Oct 2035
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Xiaofang Wang, 86-21-64175590, xiaofang0708@yeah.net
About this study
Official title: 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.
- Conditions
- Breast Cancer, Implant Breast Reconstruction
- Being tested
- ConvRT, HypoRT
- Keywords
- Breast cancer, Implant-based breast reconstruction, Hypofractionated radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConvRTRadiation
50Gy/25Fx, 2Gy/Fx, once daily
HypoRTRadiation
42.56Gy/16Fx, 2.66Gy/Fx, once daily
| Study group | Role | What they receive |
|---|---|---|
| Conventionally fractionated radiotherapy | Active comparator | Not described Receives: Radiation: ConvRT |
| Hypofractionated radiotherapy | Experimental | Not described Receives: Radiation: HypoRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of unplanned reoperation
Surgery performed to treat complications related to breast reconstruction.
Measured: 3 years
Secondary outcomes (4)
Implant-Based Breast Reconstruction Complications
Defined as adverse events following implant-based breast reconstruction, including reconstruction-related surgical complications and implant-specific complications.
Measured: 3 years
Locoregional recurrence
Locoregional recurrence is defined as the first documented recurrence in the ipsilateral chest wall or regional nodes.
Measured: 5 years
Distant metastasis
Distant metastasis is the first confirmed recurrence in any distant organ/site beyond the ipsilateral chest wall and regional nodes.
Measured: 5 years
Overall survival
Overall survival is the time from randomization to death from any cause.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2033 (estimated)
- Study completionOct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 534 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinli Ma, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835139
- Sponsor's protocol ID
- FDRT-BC020
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No