Breast CancerPhase 3NCT07084519
Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
A Phase 3 study testing hypofractionated radiotherapy and conventional fractionated radiotherapy in people with Breast Cancer and Breast Reconstruction, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Breast Reconstruction, Radiation Oncology
- What is being tested?
- hypofractionated radiotherapy and conventional fractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2026to 31 Dec 2030
- Phase
- Phase 3
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 18-75 years
- Karnofsky Performance Status ≥60
- Histopathologically confirmed invasive breast adenocarcinoma
- Total mastectomy [with or without nipple-areolar complex preservation] + axillary dissection/sentinel lymph node biopsy + implant/expander placement R0 resection with negative margins
- pT3 or N2-3 disease; or pT1-2N1
- No distant metastasis
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- Completed standard neoadjuvant/adjuvant chemotherapy cycles
- ≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy
- Signed informed consent
Who cannot join
- Prior radiotherapy to chest wall or nodal regions
- Pregnancy or lactation
- T4 stage disease
- Autologous breast reconstruction of the irradiated breast
- Pre-radiotherapy local/regional/distant metastasis
- Grade ≥3 implant-related adverse events irreversible before radiotherapy
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- Bilateral breast cancer requiring bilateral radiotherapy
- Concurrent/secondary malignancy with disease-free interval <5 years [except non-melanoma skin cancer, papillary/follicular thyroid cancer, or cervical carcinoma in situ]
- Active collagen vascular disease, e.g., SLE, scleroderma
- Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders
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
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Province, 10000
Shulian Wang, MD, 8810-87787659, wangsl@cicams.ac.cn
About this study
Official title: Randomized Controlled Trial of Postmastectomy Hypofractionated Radiotherapy Versus Conventional Fractionated Radiotherapy in Breast Cancer Patients Undergoing Prosthetic Breast Reconstruction
This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction.
Study Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction.
Intervention:
HFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)
- Conditions
- Breast Cancer, Breast Reconstruction, Radiation Oncology
- Being tested
- hypofractionated radiotherapy, conventional fractionated radiotherapy
- Keywords
- breast cancer, prosthetic 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.
hypofractionated radiotherapyRadiation
43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
conventional fractionated radiotherapyRadiation
50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| HFRT group | Experimental | 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks) Receives: Radiation: hypofractionated radiotherapy |
| CFRT group | Other | 50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks Receives: Radiation: conventional fractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconstruction Failure Rate
implant removal, capsular contracture ≥ Baker grade III
Measured: 2 year
Secondary outcomes (10)
Other Implant-Related Adverse Events
infection, skin necrosis, implant exposure
Measured: 2 year
Radiation-Related Toxicities
grade ≥3 dermatitis, pneumonitis, lymphedema
Measured: 2 year
DFS
Disease-Free Survival
Measured: 5 year
OS
Overall Survival
Measured: 5 year
LRR
Locoregional Recurrence Rate
Measured: 5 year
DM
Distant Metastasis Rate
Measured: 5 year
Cosmetic Outcome Assessed by Harvard Breast Cosmesis Scale (Physician-Rated)
Physicians will assess cosmetic outcome using the Harvard Breast Cosmesis Scale.
Unit of Measure: Score on Harvard Breast Cosmesis Scale Scale Information: Score range from 1 (Excellent) to 4 (Poor). Higher scores indicate worse cosmetic outcomes.
Measured: 1 year
Patient-Reported Cosmetic Outcome
Description: Patients will self-assess cosmetic outcome using a 4-point Likert scale.
Unit of Measure: Score on 4-point Likert scale. Scale Information: Score range from 1 (Excellent) to 4 (Poor). Higher scores indicate worse perceived outcome.
Measured: 1 year
Quality of Life Assessed by BREAST-Q (Breast Reconstruction Module), Version 2.0
The BREAST-Q (Breast Reconstruction Module), Version 2.0 will be used to evaluate patients' global health status and overall quality of life.
Unit of Measure: Score on a scale Scale Information: Score ranges from 0 to 100; higher scores indicate better global health status.
Measured: Baseline, 6 months, and 12 months after treatment
Quality of Life Assessed by EORTC QLQ-BR23 Breast Cancer Module
The EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23) will be used to assess breast cancer-specific quality of life.
Unit of Measure: Score on a scale Scale Information: Score ranges from 0 to 100. For functional scales, higher scores indicate better function; for symptom scales, higher scores indicate worse symptoms.
Measured: Baseline, 6 months, and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start27 Mar 2026
- Primary completion27 Mar 2029 (estimated)
- Study completion31 Dec 2030 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 506 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shulian Wang,MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084519
- Sponsor's protocol ID
- NCC5419
- Status last verified
- Jun 2025
- First submitted
- 2 Jul 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD includes sensitive participant information. Premature sharing could compromise publication opportunities or patent filings.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Postmastectomy Hypofractionated Radiotherapy Versus Conventional Fractionated Radiotherapy in Breast Cancer Patients Undergoing Prosthetic Breast Reconstruction
- ClinicalTrials.gov ID
- NCT07084519
- Acronym / sponsor ID
- NCC5419
- Conditions
- Breast Cancer, Breast Reconstruction, Radiation Oncology
- Keywords
- breast cancer, prosthetic breast reconstruction, hypofractionated radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 27 Mar 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Jul 2025 (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 study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction.
Study Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction.
Intervention:
HFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFRT group | Experimental | Radiation: hypofractionated radiotherapy43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks) |
| CFRT group | Other | Radiation: conventional fractionated radiotherapy50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female, aged 18-75 years
- Karnofsky Performance Status ≥60
- Histopathologically confirmed invasive breast adenocarcinoma
- Total mastectomy [with or without nipple-areolar complex preservation] + axillary dissection/sentinel lymph node biopsy + implant/expander placement R0 resection with negative margins
- pT3 or N2-3 disease; or pT1-2N1
Key exclusion criteria (10 listed)
- Prior radiotherapy to chest wall or nodal regions
- Pregnancy or lactation
- T4 stage disease
- Autologous breast reconstruction of the irradiated breast
- Pre-radiotherapy local/regional/distant metastasis
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 |
|---|---|---|
| hypofractionated radiotherapy43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks) | Radiation | HFRT group |
| conventional fractionated radiotherapy50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks | Radiation | CFRT group |
Primary outcome
Reconstruction Failure Rate
Time frame: 2 year
implant removal, capsular contracture ≥ Baker grade III
10 secondary outcomes
Other Implant-Related Adverse Events
Time frame: 2 year
Radiation-Related Toxicities
Time frame: 2 year
DFS
Time frame: 5 year
OS
Time frame: 5 year
LRR
Time frame: 5 year
DM
Time frame: 5 year
Cosmetic Outcome Assessed by Harvard Breast Cosmesis Scale (Physician-Rated)
Time frame: 1 year
Patient-Reported Cosmetic Outcome
Time frame: 1 year
Quality of Life Assessed by BREAST-Q (Breast Reconstruction Module), Version 2.0
Time frame: Baseline, 6 months, and 12 months after treatment
Quality of Life Assessed by EORTC QLQ-BR23 Breast Cancer Module
Time frame: Baseline, 6 months, and 12 months after treatment
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 Jun 2026.
- Individual participant dataSharing planned: No. IPD includes sensitive participant information. Premature sharing could compromise publication opportunities or patent filings.
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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 Phase 3 study testing hypofractionated radiotherapy and conventional fractionated radiotherapy in people with Breast Cancer and Breast Reconstruction, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 9 inclusion and 10 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 Jun 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xuran Zhao, MD (86-13661135602, 923791362@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reconstruction Failure Rate (time frame: 2 year). 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 Jun 2026.