Breast NeoplasmsNCT03583580
Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer
A study testing Accelerated Partial Breast Irradiation in people with Breast Neoplasms and Neoplasm Recurrence, Local, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasm Recurrence, Local
- What is being tested?
- Accelerated Partial Breast Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2018to Jul 2031
- 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Life Expectation: > 5 years
- Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
- Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
- Unifocal tumour (confirmed by diagnostic MRI)
- No lymphovascular invasion
- ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells)
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- Negative radial resection margins of >= 2 mm
- Surgical clips placed in the tumor bed
- Written informed consent.
Who cannot join
- Stage Ⅱ-Ⅲ
- Multifocal tumors
- Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive lobular carcinoma
- Paget's disease of the nipple
- Underwent oncoplastic surgery of ipsilateral breast
- Underwent neoadjuvant chemotherapy or hormonal therapy
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- Previous or simultaneous contralateral breast cancer
- Undergone ipsilateral chest wall radiotherapy
- Active collagen vascular disease.
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer
This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.
Read the detailed description
This study is a national multicenter phase II prospective clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients will receive ABPI to a total dose of 40Gy, in 10 fractions, 4Gy/fx/day, within 2 weeks. Intensity modulated radiation therapy (IMRT) technique is used. During Follow up, the locoregional recurrence,survival,acute and late adverse events,and quality of life will be prospectively evaluated.
- Conditions
- Breast Neoplasms, Neoplasm Recurrence, Local
- Being tested
- Accelerated Partial Breast Irradiation
- Keywords
- Breast conserving surgery, Accelerate partial breast irradiation, intensity-modulated radiation therapy, phase II
- Medical subject headings
- Breast Neoplasms, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Partial Breast IrradiationRadiation
Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Partial Breast Irradiation | Experimental | Accelerated partial breast irradiation (APBI) to the region of tumour bed Receives: Radiation: Accelerated Partial Breast Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
locoregional control rate
ipsilateral breast and axilla nodal relapse rate
Measured: 5 years
Secondary outcomes (3)
overall survival
any death
Measured: 5 years
disease-free survival
any recurrence or death
Measured: 5 years
distant-metastasis survival
distant metastasis
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 posted11 Jul 2018
- Study start19 Jul 2018
- Primary completionJul 2030 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 537 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shulian Wang,MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Shulian Wang, M.D., Principal investigator, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583580
- Sponsor's protocol ID
- NCC201804006
- Status last verified
- May 2026
- First submitted
- 19 Jun 2018
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer
- ClinicalTrials.gov ID
- NCT03583580
- Acronym / sponsor ID
- NCC201804006
- Conditions
- Breast Neoplasms, Neoplasm Recurrence, Local
- Keywords
- Breast conserving surgery, Accelerate partial breast irradiation, intensity-modulated radiation therapy, phase II
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 537 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 11 Jul 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.
This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.
Detailed description
This study is a national multicenter phase II prospective clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients will receive ABPI to a total dose of 40Gy, in 10 fractions, 4Gy/fx/day, within 2 weeks. Intensity modulated radiation therapy (IMRT) technique is used. During Follow up, the locoregional recurrence,survival,acute and late adverse events,and quality of life will be prospectively evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated Partial Breast Irradiation | Experimental | Radiation: Accelerated Partial Breast IrradiationAccelerated partial breast irradiation (APBI) to the region of tumour bed |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Life Expectation: > 5 years
- Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
- Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
- Unifocal tumour (confirmed by diagnostic MRI)
- No lymphovascular invasion
Key exclusion criteria (9 listed)
- Stage Ⅱ-Ⅲ
- Multifocal tumors
- Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive lobular carcinoma
- Paget's disease of the nipple
- Underwent oncoplastic surgery of ipsilateral breast
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 |
|---|---|---|
| Accelerated Partial Breast IrradiationPatients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT) | Radiation | Accelerated Partial Breast Irradiation |
Primary outcome
locoregional control rate
Time frame: 5 years
ipsilateral breast and axilla nodal relapse rate
3 secondary outcomes
overall survival
Time frame: 5 years
disease-free survival
Time frame: 5 years
distant-metastasis 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 19 May 2026.
- Individual participant dataSharing planned: 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.
Shulian Wang, M.D. principal investigator
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Partial Breast Irradiation in people with Breast Neoplasms and Neoplasm Recurrence, Local, 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 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: under way, not looking for participants, as of the sponsor's last update on 19 May 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?
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?
locoregional control rate (time frame: 5 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 19 May 2026.