NCT07832279

Brief Summary

This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
818

participants targeted

Target at P75+ for not_applicable

Timeline
97mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

September 16, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2032

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2034

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

6 years

First QC Date

September 16, 2026

Last Update Submit

September 22, 2026

Conditions

Early-Stage Breast Cancer

Keywords

Partial breast irradiationEarly-stage breast cancer1-week PBI3-week PBI

Outcome Measures

Primary Outcomes (1)

  • Adverse cosmesis

    Adverse cosmetic outcome (defined as 'Fair' or 'Poor') was evaluated by an independent panel using standard photographic assessment based on the EORTC Cosmetic Rating System.

    3 years

Secondary Outcomes (2)

  • Rate of locoregional recurrence

    5 years

  • Overall survival

    5 years

Study Arms (2)

arm 1

EXPERIMENTAL

26Gy/5F

Radiation: 1-week PBI

arm 2

ACTIVE COMPARATOR

40.05Gy/15F

Radiation: 3-week PBI

Interventions

3-week PBIRADIATION

40.05Gy/15Fx/3w, 2.67Gy/Fx, once daily

arm 2
1-week PBIRADIATION

26Gy/5Fx/1w, 5.2Gy/Fx, once daily

arm 1

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with an estimated life expectancy greater than 5 years. Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS).
  • For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric/unifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and/or PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm.
  • For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm.
  • Presence of surgical clips or distinct postoperative seroma/tissue changes in the tumor bed allowing precise target delineation.
  • ECOG performance status 0 or 1.
  • Eligible for systemic therapy, without prior neoadjuvant systemic therapy.
  • Able to tolerate radiotherapy procedures and position immobilization.
  • No contraindications to radiotherapy.
  • Written informed consent provided.

You may not qualify if:

  • Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma).
  • Positive axillary, internal mammary, or supraclavicular lymph nodes.
  • Presence of distant metastasis.
  • Paget's disease of the nipple.
  • History of prior ipsilateral or contralateral invasive breast cancer or DCIS.
  • Bilateral breast cancer.
  • Known germline BRCA1 or BRCA2 mutation.
  • Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes.
  • Active or prior second malignancy (except adequately treated non-melanoma skin cancer).
  • Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding definitive radiotherapy.
  • Pregnant or lactating patients.
  • Inability or unwillingness to comply with scheduled follow-up visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Jinli Ma

CONTACT

+86-21-64175590ma-jinli@outlook.com

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

September 16, 2026

First Posted

September 21, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2032

Study Completion (Estimated)

October 1, 2034

Last Updated

September 25, 2026

Record last verified: 2026-09

Locations

CN(1)