Preoperative treatment for recurrent breast cancer using targeted radiation
Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
NA · The Netherlands Cancer Institute · NCT06362616
This study is testing a new way to treat women aged 51 and older with recurrent low-risk breast cancer by using targeted radiation before surgery to see if it can help them avoid a mastectomy and improve their recovery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 51 Years and up |
| Sex | Female |
| Sponsor | The Netherlands Cancer Institute (other) |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06362616 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of preoperative accelerated partial breast irradiation (PAPBI) followed by breast conserving surgery (BCS) in women aged 51 and older with locally recurrent or second primary low-risk breast cancer or ductal carcinoma in situ (DCIS). The approach aims to provide an alternative to mastectomy by utilizing targeted radiation to minimize complications and improve cosmetic outcomes. Patients will receive PAPBI five times before undergoing surgery, allowing for a less invasive treatment option while assessing acute toxicity and overall effectiveness.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
Not a fit: Patients with aggressive breast cancer types, extensive disease, or those who have not completed prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive treatment option for women with recurrent breast cancer, potentially preserving breast tissue and improving quality of life.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating that preoperative radiation can be effective and safe for selected breast cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients ≥ 51 years * Ipsilateral breast cancer; recurrence or second primary * Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification associated on imaging) * Histologically proven estrogen receptor positive * HER2neu negative * In case of invasive adenocarcinoma: tumor size ≤ 3 cm. In case of DCIS alone: affected area ≤ 2.5 cm * Grade I or grade II (biopsy) * cN0M0 (No evidence of nodal or distant metastases on axillary ultrasound and, if indicated, positron emission tomography-computed tomography (PET-CT) scan) * Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision) * Interval since completion of local treatment of primary tumor \> 12 months * Previous radiotherapy (whole breast or partial) of the ipsilateral breast * Repeat breast conserving surgery feasible * World Health Organization (WHO) performance ≤ 2 * Written informed consent * The patient is legally competent Exclusion Criteria: * ≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor * Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area * Distant metastases and/or synchronous contralateral invasive or in situ carcinoma * Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS) * ER negative subtype * Lymphovascular invasion in biopsy * Neoadjuvant systemic treatment for the protocol tumor (except for pre-surgery hormonal therapy ≤ 2 months) * (Planned) oncoplastic surgery with major tissue displacement * Participation in another clinical trial that interferes with the locoregional treatment of this protocol. * It is expected that dosimetric constraints cannot be met, such as lung/heart constraints. * Patients with proven BRCA-mutations
Where this trial is running
Amsterdam
- The Netherlands Cancer Institute — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Astrid Scholten, MD PhD — The Netherlands Cancer Institute
- Study coordinator: Tess Snellen, MD
- Email: t.snellen@nki.nl
- Phone: 0205129111
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.
Conditions: Breast Cancer, Recurrent breast cancer, Preoperative, Partial breast irradiation