NCT03583580

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
537

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2017Jun 2026

Study Start

First participant enrolled

June 19, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 19, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

8.5 years

First QC Date

June 19, 2018

Last Update Submit

January 9, 2026

Conditions

Breast NeoplasmsNeoplasm Recurrence, Local

Keywords

Breast conserving surgeryAccelerate partial breast irradiationintensity-modulated radiation therapyphase II

Outcome Measures

Primary Outcomes (1)

  • locoregional control rate

    ipsilateral breast and axilla nodal relapse rate

    5 years

Secondary Outcomes (3)

  • overall survival

    5 years

  • disease-free survival

    5 years

  • distant-metastasis survival

    5 years

Other Outcomes (3)

  • acute and late adverse events assessed by CTCAE v4.0

    5 years

  • quality of life measured with BR-23 questionnaire

    2 years

  • the incidence of second malignancy

    5 year

Study Arms (1)

Accelerated Partial Breast Irradiation

EXPERIMENTAL

Accelerated partial breast irradiation (APBI) to the region of tumour bed

Radiation: Accelerated Partial Breast Irradiation

Interventions

Accelerated Partial Breast IrradiationRADIATION

Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)

Accelerated Partial Breast Irradiation

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Recurrence, Local

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shulian Wang, M.D.

    National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2018

First Posted

July 11, 2018

Study Start

June 19, 2017

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)