Single-dose preoperative radiotherapy and repeat breast surgery for recurrent breast cancer

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 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.

Why it matters

Who can join: the full rules

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

Where it's running

• Amsterdam UMC / VU Medical Centre
  Amsterdam, Netherlands Recruiting

Study contacts

• Principal investigator: Desiree HJG van den Bongard, MD PhD — Amsterdam UMC
• Study coordinator: Janneke F van Roij, MD
• Email: j.s.vanroij@amsterdamumc.nl
• Phone: +31 611094077

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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.