A Phase II, Randomized, Open-Label Dose Optimization and Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tersolisib (LY4064809) Combined with a CDK4/6 Inhibitor and Endocrine Therapy in Adults with HR+, HER2- Advanced Breast Cancer with a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)
The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
Eligibility
Participant or their legally authorized representative is capable of giving signed informed consent
Are able to swallow capsules or tablets
Have histologically or cytologically confirmed breast cancer
locally advanced breast cancer not amenable to curative therapy (for example,
surgery) or metastatic disease, and
HR+/HER2- or HR+/HER low
Have evidence of an activating PIK3CA mutation
Has an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus
Have inflammatory or metaplastic breast cancer.
History of leptomeningeal disease or carcinomatous meningitis.
Have known and untreated or active central nervous system (CNS) metastases.
Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Are pregnant, breastfeeding, or intend to become pregnant
Have active bacterial or fungal infection that is not recovered at randomization.
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.
Privacy Policy
University of California, Irvine - Study Information Sheet
UCI Center for Clinical Research Potential Participant Database
Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research
In the instance of parental permission, “You” refers to “Your child.”
Please read the information below and ask questions about anything that you do not understand. A
researcher listed above will be available to answer your questions.
You are being asked to participate in a clinical research potential participant database to identify
potential clinical research studies you may be eligible for. Participation in this database is voluntary.
You may choose to skip any question. You may refuse to participate or discontinue your involvement
at any time without penalty or loss of benefits. You are free to withdraw from this database at any
time. If you decide to withdraw from this database you should notify the research team
immediately.
You are eligible to participate in this study if you may be interested in participating in a research trial
at UCI Health
We would like to interview you to learn more about your eligibility for current clinical research studies
at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.
Possible risks/discomforts associated with the database are hearing about potential clinical research
studies that may not be of interest to you, invasion of your privacy, or a potential breach of
confidentiality.
There are no direct benefits from participation in the database. However, this database may help
inform you on clinical research studies that you may be eligible for. Participation in UCI clinical
research studies help us gain important data and knowledge that may lead to improved treatment
options for people with similar conditions to you in the future.
There are no alternative procedures available. The only alternative is not to participate in this study.
There is no compensation for your participation in this database.
There is no cost to you for participation in this database.
All information collected will be stored confidentially in a world-class securely-hosted application,
“RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant
architecture and application rules to ensure data privacy and regulatory compliance.
Researchers will use your information to assess your eligibility for current and future clinical research
studies at UCI. You may opt out at any time.
The research team, authorized UCI personnel, and regulatory entities, may have access to your
study records to protect your safety and welfare.
While the research team will make every effort to keep your personal information confidential, it is
possible that an unauthorized person might see it. We cannot guarantee total privacy.
Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your
information, we may share them with other researchers so they can use them for other studies in the
future. We will not share your name or any other private identifiable information that would let the
researchers know who you are. We will not ask you for additional permission to share this de-identified
information
Data Retention - In accordance with UC Office of the President policy, information will be retained for
10 years after the end of the calendar year in which the research is completed.
If, during the course of this study, significant new information becomes available that may relate to
your willingness to continue to participate, this information will be provided to you by the research
team listed at the top of the form.
If you have any comments, concerns, or questions regarding the conduct of this research please
contact the researchers listed at the top of this form
Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at
IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the
researchers listed at the top of the form and have general questions; have concerns or complaints
about the research; have questions about your rights as a research subject; or have general
comments or suggestions.
What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists.
The IRB’s role is to protect the rights and welfare of human subjects involved in
research. The IRB also assures that the research complies with applicable regulations, laws, and
institutional policies.
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