Breast CancerNCT03411174
Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients
A study testing hypofractionated partial breast irradiation in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- hypofractionated partial breast irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age≥ 50 years
- Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
- Negative surgical margins
- Pathologically confirmed invasive breast cancer
- A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
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- Tumor bed is labeled with Titanium clips
- Received adjuvant hormonal treatment
- No adjuvant chemotherapy
- ECOG:0-1
- Written informed consent.
Who cannot join
- Age<50 years
- KPS<70
- Treated with neoadjuvant chemotherapy
- Treated or being treated with chemotherapy
- With severe comorbidity
- Previous breast cancer or other malignant tumor history
Show all 9Show fewer
- Previous radiotherapy for breast or thorax
- Medical contraindication for radiotherapy
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients
The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.
Read the detailed description
A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.
- Conditions
- Breast Cancer
- Being tested
- hypofractionated partial breast irradiation
- Keywords
- breast cancer, hypofractionated partial breast irradiation
- 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 partial breast irradiationRadiation
deliver 40Gy/15Fx to tumor bed areas
| Study group | Role | What they receive |
|---|---|---|
| HF-PBI | Experimental | Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks. Receives: Radiation: hypofractionated partial breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of breast cosmetic outcome
The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system
Measured: Baseline, and three years after the completion of radiation therapy
Secondary outcomes (6)
Acute radiation-induced toxicity assessed by CTCAE v4.0
acute toxicity related to skin and lung
Measured: 3weeks, 5weeks,1 and 3 months after treatment beginning
Late complications
Complications related to radiation treatment after more than 3 months.
Measured: 3 years
Ipsilateral breast tumor recurrence rate
The pathological confirmed tumor recurrence in the same breast
Measured: 5 years
Local-regional recurrence
Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain.
Measured: 5 years
Disease free survival
The interval from diagnosis to disease recurrence or death or last visit.
Measured: 5 years
Overall survival
The interval from diagnosis to death or last visit
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 posted26 Jan 2018
- Study startApr 2015
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinli Ma, Fudan University
- Investigators
- Jinli Ma, MD,PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411174
- Sponsor's protocol ID
- FDRT-BC003
- Status last verified
- May 2025
- First submitted
- 20 Feb 2017
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang X, Wang X, Xu Z, Chu Y, Chen X, Zhang L, Meng J, Shi W, Yang Z, Mei X, Yu X, Zhang Z, Guo X, Mo M, Liu G, Wu J, Shao Z, Ma J. Hypofractionated partial breast irradiation after breast-conserving surgery for patients with early stage breast cancer in China Mainland: a single-arm prospective trial. Sci Rep. 2025 Jan 31;15(1):3869. doi: 10.1038/s41598-025-88600-5.
PubMed 39890895
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03411174
- Acronym / sponsor ID
- FDRT-BC003
- Conditions
- Breast Cancer
- Keywords
- breast cancer, hypofractionated partial breast irradiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 26 Jan 2018 (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.
The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.
Detailed description
A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF-PBI | Experimental | Radiation: hypofractionated partial breast irradiationHypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female
- Age≥ 50 years
- Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
- Negative surgical margins
- Pathologically confirmed invasive breast cancer
Key exclusion criteria (9 listed)
- Age<50 years
- KPS<70
- Treated with neoadjuvant chemotherapy
- Treated or being treated with chemotherapy
- With severe comorbidity
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 partial breast irradiationdeliver 40Gy/15Fx to tumor bed areas | Radiation | HF-PBI |
Primary outcome
The change of breast cosmetic outcome
Time frame: Baseline, and three years after the completion of radiation therapy
The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system
6 secondary outcomes
Acute radiation-induced toxicity assessed by CTCAE v4.0
Time frame: 3weeks, 5weeks,1 and 3 months after treatment beginning
Late complications
Time frame: 3 years
Ipsilateral breast tumor recurrence rate
Time frame: 5 years
Local-regional recurrence
Time frame: 5 years
Disease free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Derived from this study: PubMed 39890895Zhang X, Wang X, Xu Z, Chu Y, Chen X, Zhang L, Meng J, Shi W, Yang Z, Mei X, Yu X, Zhang Z, Guo X, Mo M, Liu G, Wu J, Shao Z, Ma J. Hypofractionated partial breast irradiation after breast-conserving surgery for patients with early stage breast cancer in China Mainland: a single-arm prospective trial. Sci Rep. 2025 Jan 31;15(1):3869. doi: 10.1038/s41598-025-88600-5.
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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. This study is not recruiting at the moment.
Jinli Ma, MD,PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypofractionated partial breast irradiation in people with Breast Cancer, 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 9 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: finished, as of the sponsor's last update on 13 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of breast cosmetic outcome (time frame: Baseline, and three years after the completion of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03411174, which also lists 1 linked publication.
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 13 May 2025.