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

Launched by AMSTERDAM UMC, LOCATION VUMC · Oct 11, 2024

Keywords

ClinConnect Summary

The REPEAT trial is a clinical study looking at a new approach for treating women with recurrent breast cancer in the same breast after previous treatment. This trial is testing a method called single-dose preoperative partial breast irradiation (PBI), which delivers a concentrated dose of radiation to the tumor before surgery. The goal is to see if this treatment can safely reduce the size of the tumor, making it easier to remove with a second breast-conserving surgery (BCS), while also minimizing side effects and improving the appearance of the breast.

To participate in this trial, women must be at least 50 years old, have a specific type of recurrent breast cancer that is 2 cm or smaller, and have no other serious health issues. Participants can expect to receive radiation treatment, followed by surgery about three weeks later. During the study, their health will be monitored for any side effects, and researchers will look at how well the treatment works over the next five years. This trial aims to find a safer and more effective way to treat recurrent breast cancer while preserving as much healthy tissue as possible.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female ≥ 50 years with an ipsilateral invasive recurrent breast cancer event after previous breast-conserving surgery and postoperative whole breast irradiation
• • World Health Organization performance status 0-2
• • Tumor size ≤ 2 cm and unifocal on MRI
• * Tumor histology as assessed on biopsy:
• • Bloom-Richardson grade 1 or 2 Non-lobular invasive histological type carcinoma Estrogen receptor positive HER2 receptor negative No lymphovascular invasion
• • No extensive DCIS (outside tumor size of 2 cm) on mammography or tumor biopsy, including non-mass enhancement on MRI
• • Clinical node negative on 18-F FDG PET-CT, ultrasound and MRI
• • No distant metastasis
• • No or mild late toxicity (no grade 2 or higher) from previous breast-conserving therapy
• • Adequate understanding of the Dutch language
• Exclusion Criteria:
• • Ipsilateral invasive breast cancer event less than two years after first breast-conserving therapy for breast cancer
• • Other malignancy within 5 years before ipsilateral breast recurrence diagnosis. For carcinoma in situ no specific time span to ipsilateral breast recurrence diagnosis is required for inclusion
• • Known breast cancer mutation gene carrier
• • Collagen synthesis disease (e.g. osteogenesis imperfect, Ehlers-Danlos syndrome, systemic sclerosis)
• • Previous ipsilateral mastectomy
• • Invasive lobular carcinoma, DCIS without invasive cancer
• • MRI absolute contraindications
• • Indication for treatment with neoadjuvant chemotherapy
• • Legal incapacity