Safety follow-up for hormone-positive, HER2-negative breast cancer
Treatments studied
Part of Cancer, Skin clinical trials.
This trial studies the safety of continuing endocrine therapy with ovarian suppression (for women) after you finish the earlier OVELIA study. It may help doctors confirm that the treatment remains safe for longer-term use.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You already completed the OVELIA study (specifically Visit 9 at Week 48) and your doctor feels you can continue endocrine therapy plus ovarian suppression (women) or endocrine plus a GnRH shot (men).
- You can understand the study and sign informed consent in writing.
- For women, you must be age 18 to 51 (inclusive).
- Your overall health should be good enough: life expectancy at least 12 months and ability to function well (ECOG score less than 3).
- Your organ tests should be acceptable: liver and kidney blood tests must be below the study’s safety limits and you must not have severe liver disease.
- Your heart testing and medicines must be safe: the ECG must meet limits, and you must not start new medicines that can affect heart rhythm (QT/QTc).
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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