NCT06677944 Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer
| NCT ID | NCT06677944 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yonsei University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 47 participants |
| Start Date | 2023-10-13 |
| Primary Completion | 2025-10-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 47 participants in total. It began in 2023-10-13 with a primary completion date of 2025-10-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In the management of early breast cancer patients, postoperative radiotherapy following breast-conserving surgery has been established as the standard treatment. Over the past two decades, significant changes have occurred in radiotherapy for breast cancer, encompassing dose fractionation methods, radiotherapy techniques, and delineation of the radiation field. Hypofractionated radiotherapy has been reported in numerous randomized phase 3 studies to show equivalent tumor control rates, reduced acute side effects, and similar late side effects compared to conventional fractionation. Among hypofractionated radiotherapy approaches, particularly in early-breast cancer, accelerated partial breast irradiation (APBI) may be chosen over whole breast irradiation (WBI). This approach is based on data indicating that the majority of local recurrences in breast cancer occur around the site of the primary tumor. By targeting radiation to the involved breast region, it becomes possible to increase the dose per fraction while shortening the overall treatment duration due to the smaller radiation treatment volume. While careful patient selection is crucial, multiple clinical studies have demonstrated that APBI, particularly after breast-conserving surgery, yields satisfactory local control rates comparable to WBI. This is accompanied by reduced side effects, improved convenience, enhanced quality of life, and potential cost savings. Traditionally, APBI has been administered after surgery, but there is a recent trend to explore preoperative APBI. The rationale for performing preoperative APBI includes several considerations. Firstly, compared to postoperative APBI, the precise location of visually identifiable tumors allows for more accurate and targeted radiation therapy, minimizing the impact on adjacent normal tissues and achieving superior cosmetic results. Secondly, reducing the size of the preoperative lesion may enable more conservative surgery, decreasing the extent of the surgical procedure. Thirdly, it can serve as a preparatory treatment to assess tumor responsiveness. Fourthly, in some cases, it may be administered for definitive purposes, especially in elderly or frail women who may find it challenging to undergo standard treatment due to concurrent health issues. Several clinical studies have reported the effectiveness and validity of preoperative PBI in a few cases of early breast cancer. These studies have shown low rates of acute and chronic toxicity, with excellent cosmetic outcomes. While accumulating evidence supports preoperative PBI, there is currently a lack of comparative studies with postoperative PBI. Therefore, this study aims to compare and evaluate the overall clinical advantages, including safety and efficacy, of preoperative PBI and postoperative PBI in early breast cancer patients.
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
Contact & Investigator
Yong Bae Kim
PRINCIPAL INVESTIGATOR
Department of Radiation Oncology, Yonsei University College of Medicine
Frequently Asked Questions
Who can join the NCT06677944 clinical trial?
This trial is open to female participants only, aged 45 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06677944 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06677944 currently recruiting?
Yes, NCT06677944 is actively recruiting participants. Contact the research team at ybkim3@yuhs.ac for enrollment information.
Where is the NCT06677944 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06677944 clinical trial?
NCT06677944 is sponsored by Yonsei University. The principal investigator is Yong Bae Kim at Department of Radiation Oncology, Yonsei University College of Medicine. The trial plans to enroll 47 participants.
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