Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer

NCT06677944 | Recruiting Phase 2

• 1 other identifier: 4-2023-1112
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Ductal Carcinoma in Situ; Invasive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of grade 2 or higher acute toxicities

  The grade of toxicities should be evaluated according to CTCAE version 5.0.

  Within 6 months after the start of radiotherapy

Secondary Outcomes (10)

• Pathologic complete response (CR) rate

  At the time of surgery

• Rate of any grade acute toxicities

  Within 6 months after the start of radiotherapy

• Rate of any gade late toxicities

  6 months after the start of radiotherapy

• Rate of grade 2 or higher late toxicities

  6 months after the start of radiotherapy

• BCCT.core software score

  Baseline (before radiotherapy), at 6 months, 12 months after radiotherapy

Study Arms (1)

Preoperative PBI

EXPERIMENTAL

PBI before surgery

Radiation: Preoperative PBI

Interventions

Preoperative PBI RADIATION

Preoperative PBI: 21 Gy \* 1 fraction Preoperative PBI is administered within 6 weeks of the patient's initial registration, and surgery is scheduled within 8 to 12 weeks after PBI.

Preoperative PBI

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Radiation Oncology, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Yong Bae Kim

  Department of Radiation Oncology, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Bae Kim

CONTACT

82-2-2228-8106; ybkim3@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: November 7, 2024
• Study Start: October 13, 2023
• Primary Completion: October 12, 2025
• Study Completion (Estimated): October 12, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)