Early Stage Breast CarcinomaNCT07657442
Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer
A study testing Whole-breast irradiation and tumor bed boost and Partial-breast irradiation in people with Early Stage Breast Carcinoma and Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Early Stage Breast Carcinoma, Breast Cancer
- What is being tested?
- Whole-breast irradiation and tumor bed boost and Partial-breast irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 649 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 31 Dec 2032
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status score of 0 to 2.
- Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.
- Clinical stage cT0-2N0M0.
- Underwent breast-conserving surgery.
- Negative surgical margins greater than 2 mm.
Who cannot join
- Regional lymph node metastasis.
- Distant metastasis.
- Bilateral breast cancer.
- Prior thoracic radiotherapy.
- Life expectancy of less than 5 years.
- Lactating or pregnant women.
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
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Shu-Lian Wang, 8610-87788803, wangsl@cicams.ac.cn
About this study
Official title: A Prospective Study of Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer
This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.
Read the detailed description
Eligible patients with early breast cancer who have undergone breast-conserving surgery will be stratified into a high-risk group or a low-risk group according to the presence or absence of predefined high-risk factors.
Patients in the high-risk group will receive whole-breast irradiation with a simultaneous integrated boost to the tumor bed. The prescribed dose will be 36 Gy in 15 fractions over 3 weeks to the whole breast and 48 Gy in 15 fractions over 3 weeks to the tumor bed.
Patients in the low-risk group will receive partial-breast irradiation. Two hypofractionated schedules may be used: 40.05 Gy in 15 fractions over 3 weeks or 26 Gy in 5 fractions over 1 week.
Patients will be followed during and after radiotherapy to evaluate treatment efficacy, recurrence rates, and acute and late radiation-related toxicities.
- Conditions
- Early Stage Breast Carcinoma, Breast Cancer
- Being tested
- Whole-breast irradiation and tumor bed boost, Partial-breast irradiation
- Keywords
- breast cancer, 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.
Whole-breast irradiation and tumor bed boostRadiation
Whole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions
Partial-breast irradiationRadiation
Partial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: High-risk group | Active comparator | Patients who undergo upfront breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present:
* Age younger than 40 years.
* Histology of invasive lobular carcinoma or micropapillary carcinoma.
* Multifocal disease, defined as two or more breast tumor foci.
* Tumor size greater than 3 cm.
* Lymphovascular invasion.
* Invasive carcinoma with an extensive intraductal component.
* Estrogen receptor-negative disease.
Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present:
* Age younger than 40 years.
* Histology of invasive lobular carcinoma or micropapillary carcinoma.
* Multifocal breast tumor before treatment.
* Lymphovascular invasion.
* Pathologic stage ypT1-2N0. Receives: Radiation: Whole-breast irradiation and tumor bed boost |
| Arm 2: Low-risk group | Active comparator | Patients who undergo upfront breast-conserving surgery will be assigned to the low-risk group if they meet either of the following criteria:
① Ductal carcinoma in situ (DCIS): age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, estrogen receptor-positive disease, and low-, intermediate-, or high-grade disease.
② Invasive carcinoma, including invasive ductal carcinoma, mucinous carcinoma, papillary carcinoma, or tubular carcinoma: age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, grade 1 to 3 disease, no lymphovascular invasion, and estrogen receptor-positive disease.
Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the low-risk group if all of the following criteria are met: Age 40 years or older, unifocal disease on pretreatment breast MRI, pretreatment core needle biopsy showing invasive ductal carcinoma, and pathologic stage ypT0/isN0. Receives: Radiation: Partial-breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence rate
Ipsilateral breast recurrence rate
Measured: Five years
Secondary outcomes (2)
Disease-free survival rate
Disease-free survival rate
Measured: Five years
Radiation-related adverse events
Adverse events
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 649 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657442
- Sponsor's protocol ID
- NCC25/095-0095
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT07657442
- Acronym / sponsor ID
- NCC25/095-0095
- Conditions
- Early Stage Breast Carcinoma, Breast Cancer
- Keywords
- breast cancer, radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 649 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 18 Jun 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 prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.
Detailed description
Eligible patients with early breast cancer who have undergone breast-conserving surgery will be stratified into a high-risk group or a low-risk group according to the presence or absence of predefined high-risk factors.
Patients in the high-risk group will receive whole-breast irradiation with a simultaneous integrated boost to the tumor bed. The prescribed dose will be 36 Gy in 15 fractions over 3 weeks to the whole breast and 48 Gy in 15 fractions over 3 weeks to the tumor bed.
Patients in the low-risk group will receive partial-breast irradiation. Two hypofractionated schedules may be used: 40.05 Gy in 15 fractions over 3 weeks or 26 Gy in 5 fractions over 1 week.
Patients will be followed during and after radiotherapy to evaluate treatment efficacy, recurrence rates, and acute and late radiation-related toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: High-risk group | Active comparator | Radiation: Whole-breast irradiation and tumor bed boostPatients who undergo upfront breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present: * Age younger than 40 years. * Histology of invasive lobular carcinoma or micropapillary carcinoma. * Multifocal disease, defined as two or more breast tumor foci. * Tumor size greater than 3 cm. * Lymphovascular invasion. * Invasive carcinoma with an extensive intraductal component. * Estrogen receptor-negative disease. Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present: * Age younger than 40 years. * Histology of invasive lobular carcinoma or micropapillary carcinoma. * Multifocal breast tumor before treatment. * Lymphovascular invasion. * Pathologic stage ypT1-2N0. |
| Arm 2: Low-risk group | Active comparator | Radiation: Partial-breast irradiationPatients who undergo upfront breast-conserving surgery will be assigned to the low-risk group if they meet either of the following criteria: ① Ductal carcinoma in situ (DCIS): age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, estrogen receptor-positive disease, and low-, intermediate-, or high-grade disease. ② Invasive carcinoma, including invasive ductal carcinoma, mucinous carcinoma, papillary carcinoma, or tubular carcinoma: age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, grade 1 to 3 disease, no lymphovascular invasion, and estrogen receptor-positive disease. Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the low-risk group if all of the following criteria are met: Age 40 years or older, unifocal disease on pretreatment breast MRI, pretreatment core needle biopsy showing invasive ductal carcinoma, and pathologic stage ypT0/isN0. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ECOG performance status score of 0 to 2.
- Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.
- Clinical stage cT0-2N0M0.
- Underwent breast-conserving surgery.
- Negative surgical margins greater than 2 mm.
Key exclusion criteria (6 listed)
- Regional lymph node metastasis.
- Distant metastasis.
- Bilateral breast cancer.
- Prior thoracic radiotherapy.
- Life expectancy of less than 5 years.
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 |
|---|---|---|
| Whole-breast irradiation and tumor bed boostWhole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions | Radiation | Arm 1: High-risk group |
| Partial-breast irradiationPartial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions | Radiation | Arm 2: Low-risk group |
Primary outcome
Local recurrence rate
Time frame: Five years
Ipsilateral breast recurrence rate
2 secondary outcomes
Disease-free survival rate
Time frame: Five years
Radiation-related adverse events
Time frame: Five 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 18 Jun 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 Whole-breast irradiation and tumor bed boost and Partial-breast irradiation in people with Early Stage Breast Carcinoma and Breast Cancer, 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 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.
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 Shu-Lian Wang, MD (8610-87788803, wangsl@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence rate (time frame: Five 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 18 Jun 2026.