Accelerated Partial Breast Irradiation With IMRT in Early... | NCT03583580

Studies
Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

NCT03583580

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

Active, not recruiting

Last Update Posted

May 19, 2026Actual

Enrollment

537Estimated

Phase

Not Applicable

Conditions

Breast Neoplasms
Neoplasm Recurrence, Local

Interventions

Accelerated Partial Breast Irradiation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2018Actual

Primary Completion Date

Jul 2030Estimated

Completion Date

Jul 2031Estimated

First Submitted Date

Jun 19, 2018

First Submission Date that Met QC Criteria

Jun 28, 2018

First Posted Date

Jul 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2026

Last Update Posted Date

May 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

537Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Accelerated Partial Breast Irradiation	Experimental	Accelerated partial breast irradiation (APBI) to the region of tumour bed	Radiation: Accelerated Partial Breast Irradiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Accelerated Partial Breast Irradiation	Radiation	Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)	Accelerated Partial Breast Irradiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
locoregional control rate	ipsilateral breast and axilla nodal relapse rate	5 years

Secondary Outcomes

Measure	Description	Time Frame
overall survival	any death	5 years
disease-free survival	any recurrence or death	5 years

Other Outcomes

Measure	Description	Time Frame
acute and late adverse events assessed by CTCAE v4.0	acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result	5 years
quality of life measured with BR-23 questionnaire

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)
Negative radial resection margins of >= 2 mm
Surgical clips placed in the tumor bed
Written informed consent.

Exclusion Criteria:

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
Previous or simultaneous contralateral breast cancer
Undergone ipsilateral chest wall radiotherapy
Active collagen vascular disease.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

female only

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shulian Wang, M.D.	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences		Beijing	Beijing Municipality	100021	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D009364	Neoplasm Recurrence, Local

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided