RecruitingPhase 3

A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well tersolisib works and how safe it is when added to other cancer drugs. It is for people with advanced breast cancer that uses hormones to grow, is HER2-negative or HER2-low, and has a change in the PIK3CA gene.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Agree to follow the study’s birth control rules.
  • If assigned female at birth, you may join before, during, or after menopause. Before or during menopause, you must agree to take medicine that stops the ovaries from making hormones.
  • If assigned male at birth and your cancer uses estrogen to grow, you must agree to take medicine to lower hormone levels.
  • Have breast cancer confirmed by a tissue or cell test. It must have spread or be too advanced for treatment that could cure it, use hormones to grow, and meet the study’s HER2 test rules.
  • Have a PIK3CA gene change shown by a tumor or blood test.
  • Have cancer that can be measured, or cancer in the bones that doctors can check.
  • For Part 1: Have had no more than 2 treatments that act throughout the body for advanced breast cancer. Only 1 may have included chemotherapy.
  • For Part 2: Have had no treatment that acts throughout the body for advanced breast cancer. You must also meet rules about earlier hormone treatment and when cancer returned. If you took a CDK4/6 drug before or after surgery, cancer must have worsened more than 12 months after you finished that drug.

Who can't join

  • Have type 1 diabetes, or type 2 diabetes that needs insulin, has an A1c of 8% or higher, or has fasting blood sugar of 140 mg/dL or higher. A1c measures blood sugar over time.
  • Have inflammatory or metaplastic breast cancer, which are specific types of breast cancer.
  • Have ever had cancer in the tissues or fluid around the brain or spinal cord.
  • Have untreated or active cancer spread to the brain or spinal cord. Treated spread may be allowed if it causes no symptoms, scans show no growth or bleeding for at least 28 days, and no seizure medicines or whole-body steroids are needed for at least 28 days before study group assignment.
  • Have had cancer treatment too recently before study group assignment. The required wait is 14 days or the time for four halves of the drug to clear, whichever is longer, up to 28 days.
  • Have a weakened immune system, take long-term whole-body steroids above the allowed dose, or used other immune-lowering treatment within 7 days before study group assignment. The steroid limit is more than 10 mg of prednisone, or an equal dose, daily.
  • Are pregnant, breastfeeding, or planning pregnancy during the study or within the required waiting periods: 6 months after the last study drug dose and at least 2 years after the last fulvestrant or CDK4/6 drug dose.
  • Have an active bacterial or fungal infection that has not cleared by study group assignment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. * If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist. * If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist. * Have histologically or cytologically confirmed breast cancer, defined as individuals with * locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and * hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines * HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally * HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines * Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay. * Have measurable disease or non-measurable, evaluable bone disease * Part 1: * Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease. * Up to 1 of these prior systemic treatments may contain chemotherapy * Part 2: * Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease. * Individuals who are eligible are either * Population 1 (P1): Endocrine sensitive * newly diagnosed with advanced breast cancer (de novo) * participants with a history of HR+, HER2- EBC and did not receive SOC adjuvant ET * relapsed with documented evidence of progression greater than (\>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, or * Population 2 (P2): Endocrine resistant * relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor. * if a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be \>12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy. Exclusion Criteria: * Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter \[mmol/L\]), or requiring insulin. * Have inflammatory or metaplastic breast cancer. * History of leptomeningeal disease or carcinomatous meningitis. * Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization. * Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days. * Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams \[mg\] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization. * Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and/or CDK4/6 inhibitor after the final administration of study treatment. * Have active bacterial or fungal infection that is not recovered at randomization.

Study sites (129)

AK

AR

AZ

CA

CO

CT

DC

FL

GA

HI

IA

IL

IN

KY

  • Saint Elizabeth Medical Center Edgewood · Edgewood, KY 41017Matthew Kurian · Principal investigatorMore trials in Edgewood

LA

MA

MD

ME

MI

MN

MO

MS

  • North Mississippi Hematology and Oncology Associates · Tupelo, MS 38801Rana Usman · Principal investigatorMore trials in Tupelo

NC

ND

  • Sanford Fargo Medical Center · Fargo, ND 58102Anu Gaba · Principal investigatorMore trials in Fargo

NH

  • Dartmouth-Hitchcock Medical Center · Lebanon, NH 03756Muhammad Afzal · Principal investigatorMore trials in Lebanon

NJ

  • Jefferson Health - Cherry Hill · Cherry Hill, NJ 08002Steven Manobianco · Principal investigatorMore trials in Cherry Hill
  • Sidney Kimmel Cancer Center - Washington Township · Sewell, NJ 08080Steven Manobianco · Principal investigatorMore trials in Sewell
  • Atlantic Health System Overlook Medical Center · Summit, NJ 07901Bonni Guerin · Principal investigatorMore trials in Summit

NY

OH

OR

  • Good Samaritan Regional Medical Center · Corvallis, OR 97330John Strother · Principal investigatorMore trials in Corvallis
  • Oncology Associates of Oregon · Eugene, OR 97401Miho Dougherty · Principal investigatorMore trials in Eugene
  • Oregon Health and Science University · Portland, OR 97239Aimee Kohn · Principal investigatorMore trials in Portland

PA

  • St. Luke's University Health Network · Bethlehem, PA 18015Maria Hafez · Principal investigatorMore trials in Bethlehem
  • Lancaster General Hospital - Ann B Barshinger Cancer Institute · Lancaster, PA 17601Amy Clark · Principal investigatorMore trials in Lancaster
  • University of Pennsylvania Hospital · Philadelphia, PA 19104Amy Clark · Principal investigatorMore trials in Philadelphia
  • Thomas Jefferson University - Clinical Research Institute · Philadelphia, PA 19107Steven Manobianco · Principal investigatorMore trials in Philadelphia
  • Jefferson Hospital Northeast · Philadelphia, PA 19114Steven Manobianco · Principal investigatorMore trials in Philadelphia
  • Asplundh Cancer Pavilion · Willow Grove, PA 19090Steven Manobianco · Principal investigatorMore trials in Willow Grove

SC

SD

TN

TX

UT

VA

VT

  • The University of Vermont Medical Center Inc. · Burlington, VT 05401Peter Kaufman · Principal investigatorMore trials in Burlington

WA

WI