Preoperative treatment for recurrent breast cancer using targeted radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.