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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Hypofractionated Versus Conventionally Fractionated Radiotherapy After Mastectomy and Implant-Based Reconstruction: A Prospective, Randomized Controlled, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07835139
- Acronym / sponsor ID
- FDRT-BC020
- Conditions
- Breast Cancer, Implant Breast Reconstruction
- Keywords
- Breast cancer, Implant-based breast reconstruction, Hypofractionated radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2033 (estimated)
- Study completion
- Oct 2035 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventionally fractionated radiotherapy | Active comparator | Radiation: ConvRT |
| Hypofractionated radiotherapy | Experimental | Radiation: HypoRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConvRT50Gy/25Fx, 2Gy/Fx, once daily | Radiation | Conventionally fractionated radiotherapy |
| HypoRT42.56Gy/16Fx, 2.66Gy/Fx, once daily | Radiation | Hypofractionated radiotherapy |
Primary outcome
The rate of unplanned reoperation
Time frame: 3 years
Surgery performed to treat complications related to breast reconstruction.
4 secondary outcomes
Implant-Based Breast Reconstruction Complications
Time frame: 3 years
Locoregional recurrence
Time frame: 5 years
Distant metastasis
Time frame: 5 years
Overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConvRT and HypoRT in people with Breast Cancer and Implant Breast Reconstruction, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinli Ma, MD, PhD (+86-21-64175590, ma-jinli@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of unplanned reoperation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.