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Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial

NCT06640881 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-10-01

No results posted yet for this study

Summary

Over the past decades, interest in second breast-conserving therapy (BCT) has increased due to, among others, advancements in radiotherapy techniques. Preoperative partial breast irradiation (PBI) is an experimental treatment for patients with low-risk primary breast cancer. This approach can downstage the tumor, and may possibly reduce toxicity and improve cosmetic outcomes compared to postoperative radiotherapy. This study aims to evaluate the feasibility of single-dose preoperative PBI and second breast-conserving surgery (BCS) for patients with an ipsilateral recurrent breast event (IRBE) after previous BCT.

The REPEAT trial is a multicenter, prospective, single-arm trial investigating ablative single-dose preoperative PBI in patients with an IRBE. Eligible patients are ≥ 50 years, have a unifocal non-lobular invasive breast cancer ≤ 2 cm, Bloom-Richardson grade 1 or 2, estrogen receptor-positive, HER2-negative and clinically negative axillary lymph nodes. The study plans to enroll 25 patients. Radiotherapy planning will involve the use of CT and MRI in the treatment position. Single-dose PBI of 20 Gy to the tumor and 15 Gy to the surrounding 2 cm of breast tissue will be delivered using a conventional or MR-guided linear accelerator. Tumor response will be monitored preoperatively using MRI and liquid biopsies to identify biomarkers for evaluating radiosensitivity. BCS will be performed 3 weeks post-PBI. The primary endpoint is the incidence of grade 2 or higher treatment-associated acute toxicity within 90 days. Secondary endpoints include the evaluation of acute (grade 1) and late toxicity, radiologic and pathologic response, mastectomy rate, patient-reported outcomes, cosmetic outcome, local, regional and distant recurrence rates, survival outcome, and biomarkers in liquid biopsies and tumor tissue. Patients will be followed up to 5 years after PBI.

This trial will evaluate the feasibility of single-dose preoperative PBI and BCS for patients with IRBE. This treatment approach is expected to minimize the irradiated volume, reduce toxicity, and improve cosmetic outcomes compared to postoperative PBI after second BCS. Identifying biomarkers for radiosensitivity will help in selection patients and tailoring treatment.

Conditions

  • Recurrent Breast Carcinoma
  • Ipsilateral Recurrence

Interventions

RADIATION

ablative single-dose PBI

ablative single-dose PBI followed by BCS after three weeks At baseline (prior to RT) and prior to BCS, toxicity, PROMS and cosmetic outcome will be assessed. Additionally, a preoperative MRI will be performed three weeks following RT to evaluate the acute tumor response.

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Desiree HJG van den Bongard, dr · AUMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06640881 on ClinicalTrials.gov