Comparing partial breast irradiation to no irradiation for early breast cancer in women

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 clinical trial aims to identify low-risk breast cancer patients who can safely omit adjuvant partial breast irradiation (PBI) after breast-conserving surgery. The study will evaluate the effectiveness of avoiding radiation therapy in selected patients who are unlikely to benefit from it, thereby reducing the risk of side effects associated with radiation. By analyzing patient characteristics and outcomes, the trial seeks to establish criteria for determining which patients can forgo radiation without significantly increasing their risk of local cancer recurrence. The approach is based on previous findings that suggest low local recurrence rates in similar patient populations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Female patient \>=60 years

Primary tumour characteristics by conventional histopathology

* unilateral and unifocal non-lobular histology grade 1-2
* maximum microscopic size \<=20mm
* node negative determined by sentinel node or axillary lymph node dissection
* estrogen receptor \>=10% positive
* HER2 negative (by IHC and/or in situ hybridization)
* resection margin \>=2 mm for invasive carcinoma and any ductal carcinoma in situ associated with the cancer

Surgical type is breast conservation

Performance status ECOG 0-2

No evidence of distant metastasis

Exclusion Criteria:

* multifocal or multicentric invasive carcinoma or ductal carcinoma in situ
* evidence of clinical or pathological T4 breast cancer
* grade 3 malignancy
* previous breast cancer or DCIS irrespective of disease-free interval
* previous radiation therapy to the breast or thorax,
* previous neoplasm within 5 years except carcinoma in situ of the cervix, endometrium or coli, melanoma in situ.
* comorbidity precluding the patient from radiation therapy (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).
* mental/psychiatric disorder which precludes the patient from understanding the randomization and the follow up.
* documented hereditary breast cancer or with high genetic risk of breast cancer
* life expectancy \<10 years

Where it's running

• Ponticia Universidad Catolica de Chile
  Santiago, Chile Recruiting
• Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Herlev Hospital
  Herlev, Denmark Recruiting
• Naestved Hospital
  Næstved, Denmark Recruiting

Study contacts

• Principal investigator: Birgitte V Offersen, PhD — Danish Breast Cancer Group
• Study coordinator: Birgitte V Offersen, PhD
• Email: bvo@oncology.au.dk
• Phone: +45 28838012

Similar studies

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

• Disposable noninvasive skin closure to help healing and reduce scarring after plastic surgery

  This study tests a disposable noninvasive skin closure device on one side of a plastic surgery incision to see if it helps wounds heal better and results in less scarring.

  Recruiting Peking University Third Hospital · Beijing, Beijing Municipality · NCT07849010

• Affordable, tailored physical therapy for financially vulnerable people after trauma

  We’re testing whether a patient-friendly, low-cost approach to physical therapy helps adults with trauma injuries who are financially vulnerable maintain or improve their quality of life.

  Recruiting Radboud University Medical Center · Nijmegen, Gelderland · NCT07795216

• Phase II test of 9MW3811 for pathological scars

  This trial will try injections of 9MW3811 to see if they improve pathological scars in adults compared with placebo.

  Recruiting Phase 2 Mabwell (Shanghai) Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07576608

• A child-friendly way for kids to report their experiences around anesthesia and surgery

  This project will test a Danish translation of a child-friendly recovery and experience questionnaire (PedSQoR) with 4–12-year-old surgical patients to let children report their own perioperative outcomes and experiences.

  Recruiting at 3 sites Gødstrup Hospital · Aarhus, Central Jutland and 2 other locations · NCT07289152

• Myofascial release versus deep friction massage for C-section scar healing and abdominal recovery

  This study will test whether myofascial release or deep friction massage helps women with long-term C-section scar pain improve abdominal recovery and scar symptoms.

  Recruiting Cairo University · Alexandria · NCT07130747

• Using patient-reported questionnaires to monitor quality of life during first-line chemo-immunotherapy for advanced NSCLC

  This project will test whether regular online questionnaires about symptoms and quality of life can help track health and treatment effects in adults with stage IV NSCLC starting first-line chemo-immunotherapy.

  Recruiting IRCCS San Raffaele · Milan, Italy · NCT07061379

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.