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

RecruitingPhase 2Ages 50 Years - anyFemaleAmsterdam UMC, location VUmc
NCT06640881 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 rec

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📋 Eligibility rules (as published)
Inclusion criteria: * WHO performance scale ≤ 2 * Females at least 50 years of age with an ipsilateral invasive breast cancer event or DCIS (i.e. recurrence, second primary) after previous breast conserving surgery and radiotherapy (for invasive breast cancer/carcinoma in situ) * Tumor characteristics: - - Tumor size ≤ 2 cm, unifocal on MRI On tumor biopsy: * Bloom-Richardson grade 1 or 2, * non-lobular invasive histological type carcinoma, * accompanying (non-extensive) DCIS is accepted within the tumor size of 2 cm on mammography and/or tumor biopsy, including no non-mass enhancement on MRI, * ER-positive and HER2-negative tumor, * No lymphovascular invasion. * Clinical node negative on PET-CT, ultrasound and MRI * No distant metastases * Repeat breast-conserving surgery is feasible, if no or mild late toxicity (no grade 2 or higher) from previous breast-conserving therapy * Adequate communication and understanding skills of the Dutch language * Written informed consent Exclusion criteria: * Ipsilateral invasive breast cancer recurrence less than 2 years after first breast conserving therapy for breast cancer or ductal carcinoma in situ * Legal incapacity * Known breast cancer mutation gene carrier * Previous ipsilateral mastectomy * Collagen synthesis disease (e.g. Osteogeneis imperfecta, Ehlers-Danlos syndrome, systemic lupus erythematosus) * Invasive lobular carcinoma * MRI absolute contraindications as defined by the Department of Radiology * Indication for treatment with neoadjuvant chemotherapy * Non-feasible dosimetric RT plan * Breast implants
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What it tests

  • ablative single-dose PBI
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Where

1 site
Amsterdam UMC / VU Medical Centre
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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