NCT07814365

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. It also compares secondary outcomes including efficacy, safety, and quality of life between the two groups.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
withdrawn

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 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

September 13, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2026

Completed
Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

Same day

First QC Date

September 4, 2026

Last Update Submit

September 12, 2026

Conditions

Early-Stage Breast Cancer

Keywords

partial breast irradiationearly-stage breast cancer1-week PBI3-week PBI

Outcome Measures

Primary Outcomes (1)

  • 3-year 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 (6)

  • Acute adverse events

    6 months

  • Late adverse events

    3 years

  • Locoregional recurrence

    5 years

  • Distant metastasis

    5 years

  • Overall survival

    5 years

  • +1 more secondary outcomes

Study Arms (2)

3-week partial breast irradiation (PBI）

ACTIVE COMPARATOR

Control group

Radiation: 3-week PBI

1-week PBI

EXPERIMENTAL

Experimental group

Radiation: 1-week PBI

Interventions

3-week PBIRADIATION

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

3-week partial breast irradiation (PBI）
1-week PBIRADIATION

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

1-week PBI

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.
  • Inability or unwillingness to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jinli Ma

    Fudan University

    PRINCIPAL INVESTIGATOR
0

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
Associate Professor

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 11, 2026

Study Start

September 13, 2026

Primary Completion

September 13, 2026

Study Completion

September 13, 2026

Last Updated

September 16, 2026

Record last verified: 2026-09

Locations

CN(1)