NCT03646955 Partial Breast Versus no Irradiation for Women With Early Breast Cancer
| NCT ID | NCT03646955 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danish Breast Cancer Cooperative Group |
| Condition | Local Neoplasm Recurrence |
| Study Type | INTERVENTIONAL |
| Enrollment | 926 participants |
| Start Date | 2018-09-05 |
| Primary Completion | 2033-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 926 participants in total. It began in 2018-09-05 with a primary completion date of 2033-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure.
Eligibility 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
Contact & Investigator
Birgitte V Offersen, PhD
PRINCIPAL INVESTIGATOR
Danish Breast Cancer Group
Frequently Asked Questions
Who can join the NCT03646955 clinical trial?
This trial is open to female participants only, aged 60 Years or older, studying Local Neoplasm Recurrence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03646955 currently recruiting?
Yes, NCT03646955 is actively recruiting participants. Contact the research team at bvo@oncology.au.dk for enrollment information.
Where is the NCT03646955 trial being conducted?
This trial is being conducted at Santiago, Chile, Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark and 11 additional locations.
Who is sponsoring the NCT03646955 clinical trial?
NCT03646955 is sponsored by Danish Breast Cancer Cooperative Group. The principal investigator is Birgitte V Offersen, PhD at Danish Breast Cancer Group. The trial plans to enroll 926 participants.