Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

January 21, 2026 updated by: Wenjie Ni, Capital Medical University

A Phase II Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.

Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100038
        • Beijing Shijitan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
  • Indication to adjuvant radiotherapy including boost radiotherapy
  • Clearly identified primary tumor region preferably by radiopaque clips
  • Primary wound healing after breast conserving therapy without signs of infection
  • Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
  • Written informed consent

Exclusion Criteria:

  • Patients operated by mastectomy
  • No indication for boost radiation
  • Resection margins positive for disease or insufficient identification of the boost volume
  • Indication for radiotherapy of the regional lymph nodes
  • History of prior breast or thoracic radiotherapy
  • Extended postoperative seroma at the beginning of radiotherapy
  • Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
  • Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionation with SIB
Radiation: Hypofractionation with simultaneous integrated boost
Hypofractionation with simultaneous integrated boost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Toxicity
Time Frame: 6 months
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the radiation plan
Time Frame: 19 days
Dose constraints Dmean lung < 10 Gy; Dmean heart < 5 Gy, Dmedian contralateral breast < 4Gy
19 days
other acute Toxicity
Time Frame: 0-6 months
All dimensions of NCI-CTCAE/RTOG
0-6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin toxicity (Cosmetic results)
Time Frame: 0 to 6 months
RTOG
0 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Principal Investigator: Wenjie Ni, MD., Beijing Shijitan Hospital, Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

May 30, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-q12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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