Study of a new drug for PIK3CA-mutated HR+ HER2- breast cancer
Treatments studied
Part of Brain & nervous system, Cancer, Genetic & congenital, Skin clinical trials.
This early-stage study tests the safety and tolerability of TOS-358 in women with HR-positive, HER2-negative breast cancer that has a specific gene change (PIK3CA). It may help learn whether this targeted treatment is safe enough to move forward.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are a woman age 18 or older
- Your breast cancer is HR-positive and HER2-negative, and it is locally advanced, recurring, or metastatic
- Your tumor has a known PIK3CA mutation or amplification from an approved lab test
- You can have up to 3 previous treatment “lines” for metastatic disease
- Your general condition is good (ECOG score 0 or 1) and you have disease that can be measured or evaluated
- Your blood sugar is controlled (fasting glucose ≤ 140 mg/dL and HbA1c ≤ 7.0%) and your organs (bone marrow, liver, kidneys) work well enough for treatment
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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