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.
Similar studies
Other trials that look related to this one.
This trial tests tersolisib, a new targeted medicine, in adults with advanced or hard-to-remove solid cancers. It focuses on tumors that have a specific genetic change (PI3Kα mutation) to see how well the treatment works and what side effects it causes.
This study tests a new drug (LAE118) alone or with other treatments for advanced solid tumors, especially cancers with a specific genetic change (PIK3CA). It aims to see if the drug is safe and effective, and may help if standard treatments have stopped working.
This trial tests an experimental drug (LOXO-783) for people with advanced breast cancer or other solid tumors that have a specific change in the PIK3CA gene. The goal is to see if the drug can shrink or slow the growth of the cancer.
This trial tests a new combination of two drugs (JS105 plus dalpiciclib and fulvestrant) against a standard combination (dalpiciclib plus fulvestrant) for people whose breast cancer has a PIK3CA mutation. The goal is to see if adding JS105 helps control the cancer longer.
This early study (Phase 1) tests RLY-2608, a targeted cancer drug for tumors with a PIK3CA mutation. It studies the drug alone and combined with hormone therapy (and sometimes CDK4/6 or CDK4 medicines) to see safety, dose, and whether it can shrink tumors.
This trial tests a new study drug called Tersolisib combined with other anti-cancer treatments for people with advanced breast cancer that has a specific gene change (PIK3CA). The goal is to see if the combination can help shrink or slow the cancer.
Hear when a new HR+/HER2-negative Breast Cancer trial opens
We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.