Trial studying safety and effects 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 oral medication being studied for hormone receptor-positive, HER2-negative metastatic breast cancer with PIK3CA mutations. It is designed to inhibit phosphoinositide-3-kinase alpha (PI3Kα).
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 study wants to find the highest safe dose of TOS-358 and see how well it works alone and with standard medicines for this type of breast cancer.
- Who it's for
- Women who have HR+ HER2- metastatic breast cancer and a PIK3CA mutation.
- What's involved
- Participants will take TOS-358 by mouth once or twice a day, and in part of the study they will also receive the usual medicines used for this cancer.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.