Preoperative partial breast irradiation for early-stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial investigates the safety and effectiveness of preoperative partial breast irradiation (PBI) in patients with early-stage breast cancer. The study aims to determine if preoperative PBI results in fewer radiotherapy-related side effects compared to the standard postoperative PBI. A total of 47 patients will be enrolled, and their treatment outcomes, complications, quality of life, breast aesthetics, and fibrosis will be monitored over a one-year follow-up period. Evaluations will include assessments of acute and late complications as well as patient-reported quality of life questionnaires.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed ductal carcinoma in situ (DCIS) and invasive breast cancer.
* Age ≥ 45
* cT1/cN0, tumor size ≤ 2.5cm
* ECOG 0\~2 -ER+, HER2-

Exclusion Criteria:

* cN+
* Tumor located too close to the skin or chest wall (within 5 mm)
* With previous treatment history for breast cancer
* Neoadjuvant chemotherapy
* Multicentric disease
* Diffuse microcalcification
* BRCA mutation
* Paget's disease
* In cases where tumor delineation is not achievable on CT/MRI images

Where it's running

• Department of Radiation Oncology, Yonsei University College of Medicine
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Yong Bae Kim — Department of Radiation Oncology, Yonsei University College of Medicine
• Study coordinator: Yong Bae Kim
• Email: ybkim3@yuhs.ac
• Phone: 82-2-2228-8106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.