RecruitingNot ApplicableNCT03646955

Partial Breast Versus no Irradiation for Women With Early Breast Cancer

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


Sponsor

Danish Breast Cancer Cooperative Group

Enrollment

926 participants

Start Date

Sep 5, 2018

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether women with early-stage, low-risk breast cancer who have had surgery can safely skip radiation therapy altogether, compared to receiving targeted partial breast radiation. **You may be eligible if...** - You are a woman aged 60 years or older - You have had a diagnosis of early-stage breast cancer (non-lobular type, Grade 1 or 2) - Your tumor was 20 mm or smaller - The cancer had not spread to the lymph nodes - Your cancer is hormone receptor positive (estrogen receptor positive) - The surgical margins were clear (no cancer cells at the edge of the removed tissue) - You are willing to take hormonal therapy (such as tamoxifen or an aromatase inhibitor) **You may NOT be eligible if...** - Your cancer is lobular type, high-grade, or larger than 20 mm - The cancer had spread to the lymph nodes - You are not a candidate for hormonal therapy - You have had previous breast cancer or prior radiation to the breast - You have certain genetic mutations (like BRCA1/BRCA2) that increase recurrence risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONNo partial breast irradiation

Omission of radiation therapy


Locations(17)

Ponticia Universidad Catolica de Chile

Santiago, Chile

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Herlev Hospital

Herlev, Denmark

Naestved Hospital

Næstved, Denmark

Odense University Hospital

Odense, Denmark

Vejle Hospital

Vejle, Denmark

Haukeland HUS

Bergen, Norway

Nordlandssykehuset

Bodø, Norway

Kristiansand Hospital

Kristiansand, Norway

Oslo University Hospital, Radiumhospitalet

Oslo, Norway

Stavanger Hospital

Stavanger, Norway

Tromsø University Hospital

Tromsø, Norway

Sahlgrenska University hospital

Gothenburg, Sweden

Skånes University Hospital

Lund, Sweden

Uppsala Akademiska Sjukhuset

Uppsala, Sweden

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NCT03646955


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