Actively Recruiting

Phase 2
Age: 18Years - 80Years
FEMALE
NCT06677879

A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.

Led by Shanghai Proton and Heavy Ion Center · Updated on 2025-05-30

780

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are: 1. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery? 2. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?

CONDITIONS

Official Title

A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed invasive breast cancer
  • Indications for adjuvant radiotherapy after lumpectomy or mastectomy for left breast cancer
  • Post lumpectomy: Pathology staged as pT1-3 N1-3, excluding N3c
  • Post mastectomy: Pathology staged as pT1-3 N1-3, excluding N3c, with implant placed
  • Patients who received neoadjuvant chemotherapy or endocrine/targeted therapy with postoperative stage ypT1-3 N0-3, excluding N3c
  • No distant metastasis
  • Age between 18 and 80 years
  • ECOG performance status score 0-2
  • Non-pregnant and non-lactating women
  • Provided written informed consent before radiotherapy
Not Eligible

You will not qualify if you...

  • Presence of Ductal Carcinoma In Situ (DCIS)
  • Tumor stage T4, N0, or N3c
  • Previous radiotherapy to the same (ipsilateral) chest or breast
  • Surgical margins positive or close (invasive carcinoma within 1 mm of margin)
  • Bilateral breast cancer, either simultaneous or previous on the opposite side

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Proton and Heavy Ion Center

Shanghai, China

Actively Recruiting

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Research Team

P

Ping Li, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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