NCT07537712

Brief Summary

This study aims to compare the differences in acute and long-term toxicities between intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients, with a focus on evaluating their impact on critical organs, including the heart, lungs, skin, esophagus, thyroid, and lymphatic tissues. Eligible patients will be followed for at least one year to assess the incidence and severity of both acute and late toxicities, as well as differences in patient-reported outcomes (PROs), cosmetic outcomes following breast-conserving surgery, and overall quality of life.

Trial Health

63
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Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

Study Start

First participant enrolled

April 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 6, 2026

Last Update Submit

April 13, 2026

Conditions

Breast Cancer

Keywords

Breast CancerIntensity-modulated proton therapyIntensity-modulated radiation therapyToxicity profile

Outcome Measures

Primary Outcomes (1)

  • Composite Toxicity Event

    Definition: The composite toxicity endpoint is a binary outcome (yes/no), defined as the occurrence of at least one of the following events from the start of radiotherapy up to 1 year post-treatment: Event A (Lymphedema): Development of ≥ Grade 2 upper limb lymphedema;Event B (Lymphopenia): Development of ≥ Grade 2 lymphopenia within 3 months after completion of treatment;Event C (Cardiotoxicity): Development of ≥ Grade 1 cardiotoxicity within 1 year post-treatment. All assessed according to CTCAE v5.0.This primary outcome measure will report the proportion (%) of subjects who experience at least one composite toxicity event.

    1 year

Secondary Outcomes (11)

  • Acute Radiation-Induced Cardiac Toxicity (RTOG/EORTC)

    3 months

  • Acute Radiation-Induced Non-Cardiac Toxicity (CTCAE v5.0)

    3 months

  • Chronic Radiation-Induced Skin and Cardiac Toxicity (RTOG/EORTC)

    1 year

  • Chronic Radiation-Induced Toxicity - Multi-System (CTCAE v5.0)

    1 year

  • Late Radiation-Induced Breast Toxicity (LENT-SOMA)

    1 year

  • +6 more secondary outcomes

Study Arms (2)

Intensity-modulated photon radiotherapy (IMRT/VMAT)

Participants will receive photon intensity-modulated radiation therapy (IMRT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions).

Radiation: Intensity-modulated photon radiotherapy (IMRT/VMAT)

Intensity-modulated proton therapy (IMPT)

Participants will receive photon Intensity-modulated proton therapy (IMPT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions).

Radiation: Intensity-modulated proton therapy (IMPT)

Interventions

Intensity-modulated proton therapy (IMPT)RADIATION

Participants will receive photon Intensity-modulated proton therapy (IMPT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). The prescribed dose is either 4005 cGy (RBE) in 15 fractions once daily, or 4256 cGy (RBE) in 16 fractions once daily. For patients undergoing breast-conserving surgery with high-risk features, the decision to deliver a tumor bed boost will be determined by the treating clinician. The tumor bed boost may be administered either sequentially (10-12.5 Gy (RBE) in 4-5 fractions) or concurrently (48-49.5 Gy (RBE) in 15-16 fractions). The attending physician will assess clinical indications to determine the need for regional lymph node irradiation and whether to include the internal mammary lymph nodes within the clinical target volume (CTV) of the regional nodal field.

Intensity-modulated proton therapy (IMPT)
Intensity-modulated photon radiotherapy (IMRT/VMAT)RADIATION

Participants will receive photon intensity-modulated radiation therapy (IMRT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). The prescribed dose is either 4005 cGy in 15 fractions once daily, or 4256 cGy in 16 fractions once daily. For patients undergoing breast-conserving surgery with high-risk features, the decision to deliver a tumor bed boost will be determined by the treating clinician. The tumor bed boost may be administered either sequentially (10-12.5 Gy in 4-5 fractions) or concurrently (48-49.5 Gy in 15-16 fractions). The attending physician will assess clinical indications to determine the need for regional lymph node irradiation and whether to include the internal mammary lymph nodes within the clinical target volume (CTV) of the regional nodal field.

Intensity-modulated photon radiotherapy (IMRT/VMAT)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer patients aged ≥18 years with histologically confirmed disease and indications for postoperative radiotherapy as determined by the treating physician, who are willing to receive radiotherapy using IMPT or IMRT.

You may qualify if:

  • Female patients aged ≥18 years.
  • Pathological diagnosis of invasive breast cancer or ductal carcinoma in situ.
  • Undergone breast-conserving surgery or total mastectomy, with or without stage I breast reconstruction.
  • For invasive carcinoma, sentinel lymph node biopsy, axillary lymph node sampling, or axillary lymph node dissection was performed.
  • Required postoperative adjuvant radiotherapy.
  • Karnofsky Performance Status (KPS) score ≥ 70.
  • The estimated life expectancy of greater than 5 years .
  • Planned to receive photon intensity-modulated radiotherapy (IMRT) or proton IMRT, with written informed consent obtained.

You may not qualify if:

  • Prior history of chest radiotherapy.
  • Severe cardiopulmonary dysfunction or other conditions that contraindicate radiotherapy.
  • Pregnancy or breastfeeding.
  • Concurrent active malignancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai 200025, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Lu Cao, PhD

CONTACT

+86-021-64370045cl11879@rjh.com.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor of Department of Radiation Oncology

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 17, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

CN(1)