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

NCT06640881 | Recruiting Phase 2 DMC

• 1 other identifier: NL85983.018.24
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

single-dose preoperative radiotherapy; pathologic response; radiologic response; cosmetic outcome; partial breast irradiation

Outcome Measures

Primary Outcomes (1)

• Acute toxicity

  The incidence of grade 2 or higher treatment-associated acute toxicity within 90 days

  90 days

Secondary Outcomes (7)

• Toxicity

  3,6,12 weeks and 1,2,3,4,5 years

• response

  3,6,12 weeks and 1,2,3,4,5 years

• PROMS

  3,6,12 weeks and 1,2,3,4,5 years

• cosmetic results

  3,6,12 weeks and 1,2,3,4,5 years

• oncological outcomes

  1,2,3,4,5 years

Study Arms (1)

ablative single-dose PBI followed by BCS after three weeks

EXPERIMENTAL

Eligible patients with a low-risk ipsilateral recurrent breast cancer previously treated with breast-conserving surgery and postoperative radiotherapy, will be treated with re-irradiation (i.e. ablative single-dose PBI) followed by second BCS after three weeks.

Radiation: ablative single-dose PBI

Interventions

ablative single-dose PBI RADIATION

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.

Also known as: baseline (prior to RT) and prior to BCS, toxicity, PROMS and cosmetic outcome will be assessed., a preoperative MRI will be performed three weeks following RT to evaluate the acute tumor response

ablative single-dose PBI followed by BCS after three weeks

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Ipsilateral invasive breast cancer event less than two years after first breast-conserving therapy for breast cancer
• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC / VU Medical Centre

Amsterdam, Netherlands

RECRUITING

Related Publications (1)

• Civil Y, Wurfbain L, Jonker L, van der Sangen M, Oei A, Duvivier K, Bijker N, Meijnen P, van Kesteren Z, Palacios M, Barbe E, Menke-van der Houven van Oordt W, Diepenhorst G, Thijssen V, Slotman B, Verhoeff J, Schipper RJ, van den Bongard D. Preoperative partial breast reirradiation and repeat breast-conserving surgery in patients with recurrent breast cancer: the prospective single-arm REPEAT trial - a study protocol. BMJ Open. 2025 Jul 18;15(7):e096510. doi: 10.1136/bmjopen-2024-096510.

  PMID: 40681188 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BaseLine dental cement; Lead

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Desiree HJG van den Bongard, dr

  AUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisca F Wurfbain, MD - PhD

CONTACT

+31 625414750; l.f.wurfbain@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Principal Investigator, Radiation Oncologist

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)