Plain-English translation of NCT05063136 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study is testing whether adding capecitabine—a chemotherapy medication taken as a pill—to standard hormone therapy can help prevent breast cancer from coming back in women with hormone-sensitive, HER2-negative breast cancer. Half of the participants will take the medication for one year along with at least five years of hormone therapy, while the other half will take a placebo pill (a fake pill with no active drug) for one year along with the same hormone therapy. Researchers will follow everyone for five years to see if the medication helps reduce the chance of cancer returning.
Standard hormone therapy alone is helpful for many women with this type of breast cancer, but some women still experience a cancer recurrence. This trial is testing whether adding this low-dose chemotherapy medication could give extra protection by attacking any remaining cancer cells that hormone therapy alone might miss.
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If you join this trial, you'll be randomly assigned to either take the chemotherapy pill or a placebo pill three times daily for one year, plus standard hormone therapy for at least five years. You'll have clinic visits every three months for the first two years, then every six months after that. Researchers will check for any signs of cancer returning through physical exams and imaging tests. The study will follow you for five years total, with the option to continue follow-up through phone calls or clinic visits if needed.
AI-generated summary from trial data · Jun 9, 2026 · Not medical advice
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