Looking at Treatment Options for Early Stage Hormone-Sensitive Breast Cancer

Recruiting · Phase 3 · Stage I Breast Cancer · 49 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This trial looks at how effective two treatments are for early stage breast cancer that is hormone-sensitive and HER-2 negative. It compares breast conservation surgery combined with a hormonal therapy to the same surgery plus radiation therapy. The goal is to see if skipping radiation therapy still leads to good outcomes for patients.

This is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. The trial is not regulated by the FDA for drugs or devices. It aims to include about 1,670 participants.

Who can join

Women and men aged 50 to 70 can join this trial. Participants must have had a lumpectomy and certain test results that show their cancer is early stage and not spreading. They should be able to take hormonal therapy for at least 5 years. The trial team will confirm eligibility.

Condition

Stage I Breast Cancer

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be randomly placed into one of two groups. One group will receive radiation therapy along with hormonal therapy for at least 5 years. The other group will receive only hormonal therapy for at least 5 years, without radiation. Both groups will take hormonal drugs like Tamoxifen or Anastrozole as part of their treatment.