Single-dose preoperative radiotherapy and repeat breast surgery for recurrent breast cancer
Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial - a Study Protocol
This study is testing if a single dose of targeted radiation before surgery can help older patients with recurring breast cancer have better treatment results and improve their appearance after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06640881 on ClinicalTrials.gov |
What this trial studies
This trial investigates the feasibility of using a single-dose preoperative partial breast irradiation (PBI) combined with repeat breast-conserving surgery in patients who have experienced an ipsilateral recurrence of breast cancer after previous treatment. The study focuses on patients aged 50 and older with specific tumor characteristics, aiming to downstage the tumor and improve cosmetic outcomes while reducing toxicity. By evaluating the pathologic and radiologic responses, the trial seeks to establish a new approach for managing recurrent breast cancer effectively.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 and older with a unifocal, non-lobular invasive breast cancer recurrence that meets specific histological and clinical criteria.
Not a fit: Patients with invasive breast cancer events occurring less than two years after their initial treatment or those with distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less toxic and more effective treatment option for patients with recurrent breast cancer.
How similar studies have performed: While the approach of single-dose preoperative PBI is innovative, similar studies have shown promise in improving outcomes for patients with breast cancer, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam
- Amsterdam UMC / VU Medical Centre — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Desiree HJG van den Bongard, dr — Aumc
- Study coordinator: Lisca F Wurfbain, MD - PhD
- Email: l.f.wurfbain@amsterdamumc.nl
- Phone: +31 625414750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.