Single-dose preoperative radiation for low-risk 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 effectiveness of MRI-guided single-dose preoperative partial breast radiotherapy in patients with low-risk breast cancer. Participants will receive this treatment followed by breast conserving surgery, with the timing of surgery dependent on the radiologic response observed through MRI scans. The study aims to monitor tumor response using MRI and biological markers over a follow-up period of up to 10 years to evaluate oncological outcomes and quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* WHO performance scale ≤2.
* Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.

  * Patients with an indication for chemotherapy or HER2-targeted therapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.
  * Tumor size as assessed on MRI.
* On tumor biopsy:

  * Bloom-Richardson grade 1 or 2.
  * Non-lobular invasive histological type carcinoma.
  * LCIS or (non-extensive) DCIS is accepted.
  * ER positive tumor receptor.
  * HER2 negative tumor.
* Tumor-negative sentinel node (excluding isolated tumor cells).
* Adequate communication and understanding skills of the Dutch language.

Exclusion Criteria:

* Legal incapacity.
* BRCA1, BRCA2 or CHEK2 gene mutation.
* Distant metastasis.
* Previous history of breast cancer or DCIS.
* Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion.
* For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.
* Collagen synthesis disease.
* Signs of extensive DCIS component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography).
* Invasive lobular carcinoma.
* MRI absolute contraindications as defined by the Department of Radiology.
* Nodal involvement with cytological or histological confirmation.
* Indication for treatment with (neo-)adjuvant chemotherapy.
* Non-feasible dosimetric RT plan.

Where it's running

• Flevoziekenhuis
  Almere Stad, Netherlands Recruiting
• Ziekenhuis Amstelland
  Amstelveen, Netherlands Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Canisius Wilhelmina Ziekenhuis
  Nijmegen, Netherlands Recruiting
• Radboud UMC
  Nijmegen, Netherlands Recruiting
• Zaans Medisch Centrum
  Zaandam, Netherlands Recruiting

Study contacts

• Principal investigator: Desirée van den Bongard, MD, PhD — Amsterdam UMC, location VUmc
• Study coordinator: Janneke van Roij, MD
• Email: j.s.vanroij@amsterdamumc.nl
• Phone: +31 6 11094077

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gyrotonic exercise for elders with breast cancer and Behcet disease

  We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.

  Recruiting Cairo University · Giza, Dokki · NCT07929116

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

  This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang and 21 other locations · NCT07920094

• Different skin care approaches to prevent skin reactions after mastectomy radiation

  This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07918989

• 3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy

  This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.

  Recruiting Region Skane · Lund, Skåne County · NCT07916337

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.