Breast NeoplasmsNCT03583619
Randomized Trial of Accelerated Partial Breast Irradiation
A study testing APBI and WBI 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 compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer. 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?
- APBI and WBI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2017to 23 Mar 2020
- 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 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
Show all 9Show fewer
- 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 Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer
This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.
Read the detailed description
This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.
- Conditions
- Breast Neoplasms, Neoplasm Recurrence, Local
- Being tested
- APBI, WBI
- 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.
APBIRadiation
Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.
WBIRadiation
Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.
| Study group | Role | What they receive |
|---|---|---|
| APBI | Experimental | Patients receive accelerated partial breast irradiation to tumour bed to a total dose of 40Gy, 4.0Gy per fraction, 5 fractions a week, within 2 weeks. Receives: Radiation: APBI |
| WBI | Active comparator | Patients receive whole breast irradiation to a total dose of 43.5Gy, at 2.9Gy per fraction, 5 fractions a week, within 3 weeks. Receives: Radiation: WBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number o participants with Grade 2 or more toxicity
The evaluated toxicities include the following and are evaluated by CTCAE 3.0 criteria:
acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result
Measured: 5 years
Secondary outcomes (5)
locoregional recurrence
ipsilateral breast and axillary nodal recurrence
Measured: 5 years
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
Quality of life measured with BR-23 questionnaire
BR-23 questionnaire
Measured: 2 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 2017
- Primary completion11 Jan 2019
- Study completion23 Mar 2020
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shulian Wang, 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
- NCT03583619
- Sponsor's protocol ID
- NCC-000498
- Status last verified
- Dec 2018
- First submitted
- 19 Jun 2018
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Song YC, Sun GY, Fang H, Tang Y, Song YW, Hu C, Qi SN, Chen B, Jing H, Tang Y, Jin J, Liu YP, Lu NN, Li YX, Wang SL. Quality of Life After Partial or Whole-Breast Irradiation in Breast-Conserving Therapy for Low-Risk Breast Cancer: 1-Year Results of a Phase 2 Randomized Controlled Trial. Front Oncol. 2021 Sep 15;11:738318. doi: 10.3389/fonc.2021.738318. eCollection 2021.
PubMed 34604082
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer
- ClinicalTrials.gov ID
- NCT03583619
- Acronym / sponsor ID
- NCC-000498
- Conditions
- Breast Neoplasms, Neoplasm Recurrence, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 23 Mar 2020 (actual)
- 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 compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.
Detailed description
This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APBI | Experimental | Radiation: APBIPatients receive accelerated partial breast irradiation to tumour bed to a total dose of 40Gy, 4.0Gy per fraction, 5 fractions a week, within 2 weeks. |
| WBI | Active comparator | Radiation: WBIPatients receive whole breast irradiation to a total dose of 43.5Gy, at 2.9Gy per fraction, 5 fractions a week, within 3 weeks. |
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 |
|---|---|---|
| APBIPatients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique. | Radiation | APBI |
| WBIPatients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique. | Radiation | WBI |
Primary outcome
Number o participants with Grade 2 or more toxicity
Time frame: 5 years
The evaluated toxicities include the following and are evaluated by CTCAE 3.0 criteria: acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result
5 secondary outcomes
locoregional recurrence
Time frame: 5 years
overall survival
Time frame: 5 years
disease-free survival
Time frame: 5 years
distant-metastasis survival
Time frame: 5 years
Quality of life measured with BR-23 questionnaire
Time frame: 2 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 26 Jan 2026.
- Derived from this study: PubMed 34604082Song YC, Sun GY, Fang H, Tang Y, Song YW, Hu C, Qi SN, Chen B, Jing H, Tang Y, Jin J, Liu YP, Lu NN, Li YX, Wang SL. Quality of Life After Partial or Whole-Breast Irradiation in Breast-Conserving Therapy for Low-Risk Breast Cancer: 1-Year Results of a Phase 2 Randomized Controlled Trial. Front Oncol. 2021 Sep 15;11:738318. doi: 10.3389/fonc.2021.738318. eCollection 2021.
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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 APBI and WBI 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: finished, as of the sponsor's last update on 26 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?
Number o participants with Grade 2 or more toxicity (time frame: 5 years). 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 NCT03583619, 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 26 Jan 2026.