A Study of Tersolisib (LY4064809) and Abemaciclib With Hormone Therapies in Participants With PIK3CA-Mutated Early Breast Cancer (PIKALO-3)
A Phase 2, Open-label, Randomized Study Investigating the Tolerability of Concurrent Versus Staggered Administration of Abemaciclib and Endocrine Therapy With Tersolisib in Patients With HR+, HER2- Node-Positive, PIK3CA-Mutated Early Breast Cancer.
The main purpose of this study is to compare two ways of giving the anti-cancer medicines abemaciclib and hormone therapy with tersolisib in participants with early breast cancer that has a genetic mutation (PIK3CA mutation).
For each participant, the study will last up to 56 weeks and include 12 visits.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefoonnummer: 1-317-615-4559
- E-mail: LillyTrials@Lilly.com
Studie Contact Back-up
- Naam: Physicians interested in becoming principal investigators please contact
- E-mail: clinical_inquiry_hub@lilly.com
Studie Locaties
-
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California
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Los Alamitos, California, Verenigde Staten, 90720
- Cancer and Blood Specialty Clinic
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Hoofdonderzoeker:
- Sassan Farjami
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Colorado
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Lakewood, Colorado, Verenigde Staten, 80228
- USO - Rocky Mountain Cancer Centers
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Hoofdonderzoeker:
- Sara Robinson
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30308
- Winship Cancer Institute, Emory University
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Hoofdonderzoeker:
- Manali Bhave
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Dana-Farber Cancer Institute
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Hoofdonderzoeker:
- Erica Mayer
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Ohio
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Columbus, Ohio, Verenigde Staten, 43212
- Stefanie Spielman Comprehensive Breast Center
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Hoofdonderzoeker:
- Robert Wesolowski
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Texas
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Amarillo, Texas, Verenigde Staten, 79106
- Texas Oncology - West Texas
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Hoofdonderzoeker:
- Ines Sanchez-Rivera
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Austin, Texas, Verenigde Staten, 78731
- Texas Oncology - Balcones
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Hoofdonderzoeker:
- Kathryn Hudson
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San Antonio, Texas, Verenigde Staten, 78229-3307
- South Texas Accelerated Research Therapeutics (START)
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Hoofdonderzoeker:
- Amita Patnaik
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Virginia
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Reston, Virginia, Verenigde Staten, 20190
- USO - Virginia Cancer Specialists
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Hoofdonderzoeker:
- Isabelle Le
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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Have histologically or cytologically confirmed breast cancer, defined as individuals with:
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early stage, resected, invasive breast cancer without evidence of distant metastasis, and
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have confirmed hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) status defined by
- Hormone Receptor (HR) status: documented estrogen receptor positive (ER+) and/or progesterone receptor+ tumor, defined as greater than or equal to (≥) 1% of tumor cells stained positive, assessed locally on primary disease specimen, as defined by American Society of Clinical Oncology College of American Pathologists (ASCO/CAP) Guidelines
- HER status: fulfill the requirement of HER2- disease by local testing on primary disease specimen; tumor must be HER2- according to ASCO/CAP guidelines for HER2 testing
-
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Have evidence of an activating phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) mutation in tumor tissue.
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Must have undergone definitive locoregional therapy, defined as surgery of the primary breast tumor(s), with or without radiation therapy, and/or systemic therapy (neo/adjuvant chemotherapy and or Endocrine Therapy (ET)) per standard guidelines.
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Individuals with bilateral breast cancer (diagnosis of invasive tumors in both breasts simultaneously or within 6 months of each other) may be eligible if all lesions tested on both sides are HR+ HER2- and adequate surgery has been performed for both breasts.
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Tumor involvement in at least 1 axillary lymph node (ALN).
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≥ ipsilateral positive ALN, OR
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1 to 3 ipsilateral positive ALN and either:
- tumor size ≥5cm, or
- histologic Grade 3 tumor (as defined by a combined score of at least 8 points per the modified Bloom-Richardson grading system or equivalent
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Individuals must be randomized within 16 months from the time of definitive breast cancer surgery.
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May have received up to 12 weeks of ET with AIs or tamoxifen until randomization following the last non-ET (surgery, chemotherapy, or radiation), whichever is last.
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Are willing to follow contraception requirements.
Exclusion Criteria:
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Have evidence of
- metastatic disease
- inflammatory breast cancer at primary breast cancer diagnosis
- breast cancer recurrence (local, regional, or distant), or
- a history of previous invasive breast cancer
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Has an established diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) ≥8 percent (%), fasting plasma glucose ≥140 mg/dL (7.7 mmol/L), or requiring insulin.
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Has a history of malignancy other than breast cancer
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Have active Hepatitis B Virus (HBV)
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Have active Hepatitis C Virus (HCV)
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Have untreated Human Immunodeficiency Virus (HIV) infection
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Have any other active systemic infection requiring system therapy
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Have a history of Kaposi sarcoma or multicentric Castleman disease
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Have a serious cardiac condition
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm A: Abemaciclib and Endocrine Therapy (ET) + Tersolisib - Staggered
Abemaciclib in combination with physician's choice of endocrine therapy (ET). Tersolisib will be added in a staggered approach after 2 cycles of abemaciclib and ET. All drugs will be administered orally. |
Administered orally Administered orally Administered orally Administered orally Administered orally
Andere namen:
|
|
Experimenteel: Arm B: Abemaciclib and Endocrine Therapy (ET) + Tersolisib - Concurrent
Abemaciclib and tersolisib will be administered concurrently in combination with physician's choice of ET. All drugs will be administered orally. |
Administered orally Administered orally Administered orally Administered orally Administered orally
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Rate of Participants who Discontinue Tersolisib Due to Treatment Emergent Adverse Events (TEAEs).
Tijdsspanne: Cycle 1 through study completion (estimated as 56 weeks)
|
Cycle 1 through study completion (estimated as 56 weeks)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Duration of Exposure to Study Intervention
Tijdsspanne: Start of study intervention through study completion (estimated as 56 weeks)
|
Study intervention start is defined as Cycle -1 for Arm A and Cycle 1 for Arm B. Arm A includes an additional 8 weeks. |
Start of study intervention through study completion (estimated as 56 weeks)
|
|
Number of Study Intervention Dose Adjustments
Tijdsspanne: Start of study intervention through study completion (estimated as 56 weeks)
|
Study intervention start is defined as Cycle -1 for Arm A and Cycle 1 for Arm B. Arm A includes an additional 8 weeks. |
Start of study intervention through study completion (estimated as 56 weeks)
|
|
Pharmacokinetics (PK): Predose Plasma Concentrations (Cmax) of Tersolisib
Tijdsspanne: Day 15 through study completion (estimated as 56 weeks)
|
Day 15 through study completion (estimated as 56 weeks)
|
|
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Change from Baseline in Side-Effect Burden as Measured by Functional Assessment of Cancer Therapy - General Item GP5 (FACT-GP5)
Tijdsspanne: Baseline to end of study completion (estimated as 56 weeks)
|
Baseline to end of study completion (estimated as 56 weeks)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 27842
- 2026-526410-87-00 (Ctis)
- J6M-MC-JSGH (Andere identificatie: Eli Lilly and Company)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD-tijdsbestek voor delen
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD-toegangscriteria voor delen
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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