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    Phase III: Inavolisib in Breast Cancer (INAVO123)

    Clinical Trial Overview

    A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/​6 Inhibitor and Letrozole vs Placebo + CDK4/​6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123)

    Objective

    This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

    Primary Endpoints

    • Progression-Free Survival (PFS) [Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)]

    Secondary Endpoints

    • Overall Survival (OS) [Time Frame: From randomization to death from any cause (up to 7 years)]
    • Investigator-assessed Objective Response Rate (ORR) [Time Frame: Up to 7 years]
    • Investigator-assessed Duration of Response (DOR) [Time Frame: From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)]
    • Investigator-assessed Clinical Benefit Rate (CBR) [Time Frame: Up to 7 years]
    • Time to Confirmed Deterioration (TTCD) in Pain [Time Frame: From baseline until end of follow-up (up to 7 years)]
    • TTCD in Physical Function [Time Frame: From baseline until end of follow-up (up to 7 years)]
    • TTCD in Role Function [Time Frame: From baseline until end of follow-up (up to 7 years)]
    • TTCD in Global Health Status [Time Frame: From baseline until end of follow-up (up to 7 years)]
    • Percentage of Participants with Adverse Events [Time Frame: From baseline until end of follow-up (up to 7 years)]
    • Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Time Frame: Up to 7 years]
    • Number of Participants Reporting Each Response Option for Treatment Side-effect Bother Single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General Questionnaire; (FACT-G) [Time Frame: Up to 7 years]
    • Change from Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE [Time Frame: Baseline up to 7 years]
    • Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item [Time Frame: Baseline up to 7 years]

    Inavolisib

    Other names: GDC-0077, RG6114
    Modality: Phosphoinositide 3-kinase (PI3K) inhibitor

    View Details
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    View on ClinicalTrials.gov

    Inclusion and Exclusion Criteria

    Key Inclusion Criteria Key Exclusion Criteria
    • Women or men with histologically or cytologically confirmed carcinoma of the breastFor participants of childbearing potential: agreement to remain abstinent or adhere to the contraception requirements
    • Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
    • Documented HER2-negative tumor according to ASCO/CAP guidelines
    • De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment
    • Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
    • Confirmation of biomarker eligibility
    • Consent to provide fresh or archival tumor tissue specimen
    • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
    • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
    • Metaplastic breast cancer
    • Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
    • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
    • Any history of leptomeningeal disease or carcinomatous meningitis
    • Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
    • Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
    • Symptomatic active lung disease
    • History of or active inflammatory bowel disease
    • Any active bowel inflammation
    • Prior hematopoietic stem cell or bone marrow transplantation
    • Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment

    Enrollment & Resources

    Enrollment

    For more information on eligibility criteria, view the study or reach out to our team.

    General icon

    Web

    ClinicalTrials.gov
    Identifier: NCT06790693

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    Phone

    1-888-662-6728
    (US and Canada)

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    Email icon

    Email

    [email protected]

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    Clinical Trial Site Locations

    Clinical Trial Site Locations

    For more information on recruitment status, or where the study is being conducted

    Visit ClinicalTrials.gov

    Patient Resources

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    Information is consistent with ClinicalTrials.gov as of January 16, 2026. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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    TOP

    • ABC
      advanced breast cancer

    • CDK4/6i
      cyclin-dependent kinase 4 and 6 inhibitor

    • CNS
      central nervous system

    • CR
      complete response

    • CYP3A4
      cytochrome P450 3A4

    • DOR
      duration of response

    • ER
      estrogen receptor

    • HER2-
      human epidermal growth factor receptor 2-negative

    • HR+
      hormone receptor-positive

    • OS
      overall survival

    • PFS
      progression-free survival

    • PIK3CA
      phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha

    • PIK3CAm
      PIK3CA-mutated

    • PR
      partial response