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Search / Trial NCT06677944

Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer

Launched by YONSEI UNIVERSITY · Nov 6, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to treating early-stage breast cancer called preoperative partial breast irradiation (PBI). Traditionally, radiation therapy is given after surgery, but this study is exploring whether giving radiation before surgery could be more effective. The idea is that by targeting the area around the tumor before surgery, doctors may achieve better control of the cancer, reduce side effects, and potentially allow for less extensive surgery. The trial aims to compare the safety and effectiveness of preoperative PBI to the usual postoperative PBI in women with early breast cancer.

To participate in this trial, women must be at least 45 years old and have a specific type of breast cancer (ductal carcinoma in situ or invasive breast cancer) with tumors that are 2.5 cm or smaller. They should also be in good overall health and meet certain other criteria. Participants can expect to receive targeted radiation before their surgery, and the study will monitor their health to see how well this approach works. This trial is an important step in understanding if preoperative radiation can improve outcomes for patients with early breast cancer.

Gender

FEMALE

Eligibility criteria

  • 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

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Yong Bae Kim

Principal Investigator

Department of Radiation Oncology, Yonsei University College of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported