Comparing partial breast irradiation to no irradiation for early breast cancer in women
The DBCG RT Natural Trial: Partial Breast Versus no Irradiation for Women >=60 Years Operated With Breast Conservation for an Early Breast Cancer: a Clinically Controlled Randomized Phase III Trial
NA · Danish Breast Cancer Cooperative Group · NCT03646955
This study is testing if women with early breast cancer can skip radiation treatment after surgery without increasing their chances of the cancer coming back.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 926 (estimated) |
| Ages | 60 Years and up |
| Sex | Female |
| Sponsor | Danish Breast Cancer Cooperative Group (other) |
| Drugs / interventions | radiation |
| Locations | 17 sites (Santiago and 16 other locations) |
| Trial ID | NCT03646955 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 60 and older with early-stage, low-risk breast cancer characteristics.
Not a fit: Patients with multifocal or multicentric invasive carcinoma, grade 3 malignancy, or previous breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce unnecessary radiation treatment for certain breast cancer patients, minimizing side effects and improving quality of life.
How similar studies have performed: Previous studies, such as the DBCG RT PBI trial and the UK IMPORT LOW trial, have shown promising results with similar approaches in low-risk breast cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Santiago and 16 other locations
- 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)
- Odense University Hospital — Odense, Denmark (RECRUITING)
- Vejle Hospital — Vejle, Denmark (RECRUITING)
- Haukeland HUS — Bergen, Norway (RECRUITING)
- Nordlandssykehuset — Bodø, Norway (RECRUITING)
- Kristiansand Hospital — Kristiansand, Norway (RECRUITING)
- Oslo University Hospital, Radiumhospitalet — Oslo, Norway (RECRUITING)
- Stavanger Hospital — Stavanger, Norway (RECRUITING)
- Tromsø University Hospital — Tromsø, Norway (RECRUITING)
- Sahlgrenska University hospital — Gothenburg, Sweden (RECRUITING)
- Skånes University Hospital — Lund, Sweden (RECRUITING)
- Uppsala Akademiska Sjukhuset — Uppsala, Sweden (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
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: Local Neoplasm Recurrence, Distantly Metastatic Malignant Neoplasm, Death, Fibrosis Breast, Depigmentation/Hyperpigmentation of Skin, Telangiectasia, Scar, Pain