Breast CancerNCT04913532
Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
A study testing Hypofractionation with simultaneous integrated boost in people with Breast Cancer and Surgery, run by Capital Medical University at 1 site in China.
Trial summary
Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Surgery, Adjuvant Radiotherapy
- What is being tested?
- Hypofractionation with simultaneous integrated boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2021to 31 Jul 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
- Indication to adjuvant radiotherapy including boost radiotherapy
- Clearly identified primary tumor region preferably by radiopaque clips
- Primary wound healing after breast conserving therapy without signs of infection
- Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
- Written informed consent
Who cannot join
- Patients operated by mastectomy
- No indication for boost radiation
- Resection margins positive for disease or insufficient identification of the boost volume
- Indication for radiotherapy of the regional lymph nodes
- History of prior breast or thoracic radiotherapy
- Extended postoperative seroma at the beginning of radiotherapy
- Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
- Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.
Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.
Read the detailed description
Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)
- Conditions
- Breast Cancer, Surgery, Adjuvant Radiotherapy
- Being tested
- Hypofractionation with simultaneous integrated boost
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionation with simultaneous integrated boostRadiation
Hypofractionation with simultaneous integrated boost
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionation with SIB | Experimental | Hypofractionation with SIB Receives: Radiation: Hypofractionation with simultaneous integrated boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Toxicity
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
Measured: 6 months
Secondary outcomes (2)
Feasibility of the radiation plan
Dose constraints Dmean lung < 10 Gy; Dmean heart < 5 Gy, Dmedian contralateral breast < 4Gy
Measured: 19 days
other acute Toxicity
All dimensions of NCI-CTCAE/RTOG
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start22 Jun 2021
- Primary completion30 Jun 2023
- Study completion31 Jul 2025
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 Capital Medical 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjie Ni, Capital Medical University
- Investigators
- Wenjie Ni, MD., Principal investigator, Beijing Shijitan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913532
- Sponsor's protocol ID
- 2020-q12
- Status last verified
- Jan 2026
- First submitted
- 30 May 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT04913532
- Acronym / sponsor ID
- 2020-q12
- Conditions
- Breast Cancer, Surgery, Adjuvant Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 4 Jun 2021 (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.
Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.
Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.
Detailed description
Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionation with SIB | Experimental | Radiation: Hypofractionation with simultaneous integrated boostHypofractionation with SIB |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
- Indication to adjuvant radiotherapy including boost radiotherapy
- Clearly identified primary tumor region preferably by radiopaque clips
- Primary wound healing after breast conserving therapy without signs of infection
- Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
Key exclusion criteria (8 listed)
- Patients operated by mastectomy
- No indication for boost radiation
- Resection margins positive for disease or insufficient identification of the boost volume
- Indication for radiotherapy of the regional lymph nodes
- History of prior breast or thoracic radiotherapy
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 |
|---|---|---|
| Hypofractionation with simultaneous integrated boostHypofractionation with simultaneous integrated boost | Radiation | Hypofractionation with SIB |
Primary outcome
Acute Toxicity
Time frame: 6 months
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
2 secondary outcomes
Feasibility of the radiation plan
Time frame: 19 days
other acute Toxicity
Time frame: 0-6 months
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 23 Jan 2026.
- Individual participant dataSharing planned: No. No.
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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.
Wenjie Ni, MD. principal investigator
Beijing Shijitan Hospital, Capital Medical 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 Hypofractionation with simultaneous integrated boost in people with Breast Cancer and Surgery, run by Capital Medical 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 6 inclusion and 8 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 23 Jan 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?
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?
Acute Toxicity (time frame: 6 months). 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 23 Jan 2026.