NCT03411174

Brief Summary

The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable breast-cancer

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

April 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

4.3 years

First QC Date

February 20, 2017

Last Update Submit

May 11, 2025

Conditions

Breast Cancer

Keywords

breast cancerhypofractionated partial breast irradiation

Outcome Measures

Primary Outcomes (1)

  • The change of breast cosmetic outcome

    The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system

    Baseline, and three years after the completion of radiation therapy

Secondary Outcomes (6)

  • Acute radiation-induced toxicity assessed by CTCAE v4.0

    3weeks, 5weeks,1 and 3 months after treatment beginning

  • Late complications

    3 years

  • Ipsilateral breast tumor recurrence rate

    5 years

  • Local-regional recurrence

    5 years

  • Disease free survival

    5 years

  • +1 more secondary outcomes

Study Arms (1)

HF-PBI

EXPERIMENTAL

Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks.

Radiation: hypofractionated partial breast irradiation

Interventions

hypofractionated partial breast irradiationRADIATION

deliver 40Gy/15Fx to tumor bed areas

HF-PBI

Eligibility Criteria

Age50 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Age≥ 50 years
  • Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
  • Negative surgical margins
  • Pathologically confirmed invasive breast cancer
  • A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
  • Tumor bed is labeled with Titanium clips
  • Received adjuvant hormonal treatment
  • No adjuvant chemotherapy
  • ECOG:0-1
  • Written informed consent.

You may not qualify if:

  • Age\<50 years
  • KPS\<70
  • Treated with neoadjuvant chemotherapy
  • Treated or being treated with chemotherapy
  • With severe comorbidity
  • Previous breast cancer or other malignant tumor history
  • Previous radiotherapy for breast or thorax
  • Medical contraindication for radiotherapy
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Zhang X, Wang X, Xu Z, Chu Y, Chen X, Zhang L, Meng J, Shi W, Yang Z, Mei X, Yu X, Zhang Z, Guo X, Mo M, Liu G, Wu J, Shao Z, Ma J. Hypofractionated partial breast irradiation after breast-conserving surgery for patients with early stage breast cancer in China Mainland: a single-arm prospective trial. Sci Rep. 2025 Jan 31;15(1):3869. doi: 10.1038/s41598-025-88600-5.

    PMID: 39890895DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jinli Ma, MD,PhD

    Fudan University

    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
Associate Professor of department of radiation oncology

Study Record Dates

First Submitted

February 20, 2017

First Posted

January 26, 2018

Study Start

April 1, 2015

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations

CN(1)