NCT03583619

Brief Summary

This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 19, 2017

Completed
11 months 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
Last Updated

January 26, 2026

Status Verified

December 1, 2018

Enrollment Period

1.5 years

First QC Date

June 19, 2018

Last Update Submit

January 22, 2026

Conditions

Breast NeoplasmsNeoplasm Recurrence, Local

Outcome Measures

Primary Outcomes (1)

  • 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

    5 years

Secondary Outcomes (5)

  • locoregional recurrence

    5 years

  • overall survival

    5 years

  • disease-free survival

    5 years

  • distant-metastasis survival

    5 years

  • Quality of life measured with BR-23 questionnaire

    2 years

Study Arms (2)

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.

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.

Radiation: WBI

Interventions

APBIRADIATION

Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.

APBI
WBIRADIATION

Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.

WBI

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
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

Related Publications (1)

  • 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.

    PMID: 34604082DERIVED

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
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

July 19, 2017

Primary Completion

January 11, 2019

Study Completion

March 23, 2020

Last Updated

January 26, 2026

Record last verified: 2018-12

Locations

CN(1)