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Tests treatment safety and results for HR+/HER2-negative Breast Cancer
Official title A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
ClinicalTrials.gov ID: NCT05683418
What this study is testing
What is TOS-358?
TOS-358 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hr+/her2-negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria. The main questions it aims to answer are: 1.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Key Locally advanced, recurrent, or metastatic HR +/HER2- breast cancer
- Up to 3 prior lines of therapy for metastatic disease
- Willing and able to provide written informed consent for this study
- Adults ≥ 18 years old at time of consent
- Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory using a validated test
You likely can't join if
- Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2
- Known active central nervous system (CNS) metastases
- PTEN mutations
See the full eligibility criteria
- Key Locally advanced, recurrent, or metastatic HR +/HER2- breast cancer
- Up to 3 prior lines of therapy for metastatic disease
- Willing and able to provide written informed consent for this study
- Adults ≥ 18 years old at time of consent
- Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory using a validated test
- Measurable or evaluable disease by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥ 6 months, as determined by the investigator
- Adequate bone marrow, liver, and kidney function within 14 days prior to first dose of investigational product
- Fasting plasma glucose \<= 140 mg/dL AND hemoglobin A1c (HbA1c) \<= 7.0%
- Available archived or fresh tumor tissue sample for detection of PIK3CA mutation by central laboratory test Key
- Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2
- Known active central nervous system (CNS) metastases
- PTEN mutations
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Las Vegas, Nevada, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Flower Mound, Texas, United States
- Fairfax, Virginia, United States
- Barcelona, Spain
- Madrid, Spain
- Pamplona, Spain
- Pozuelo de Alarcón, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Boston, Massachusetts, United States; Las Vegas, Nevada, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States; Flower Mound, Texas, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.