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Clinical Trials List

Protocol NumberWO45654
NCT Number(ClinicalTrials.gov Identfier)NCT06790693
Active

2025-02-01 - 2032-12-31

Phase III

Recruiting6

ICD-10C50.911

Malignant neoplasm of unspecified site of right female breast

ICD-10C50.912

Malignant neoplasm of unspecified site of left female breast

ICD-10C50.919

Malignant neoplasm of unspecified site of unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.9

Malignant neoplasm of female breast, unspecified

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator YEN-SHEN LU 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Chiang Hung 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李明陽 Division of Hematology & Oncology
Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鍾奇峰 無
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Breast Cancer

Objectives

The WO45654 (INAVO123) trial was a phase III, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of three drugs, in combination with inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i; palbociclib) and letrozole, compared with placebo plus CDK4/6i (palbociclib) and letrozole, in first-line treatment of patients with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+) and human epidermal growth factor receptor type 2-negative (HER2-) advanced breast cancer (ABC).

Test Drug

lozenges

Active Ingredient

INAVOLISIB

Dosage Form

110

Dosage

ＭＧ

Endpoints

Evaluate the efficacy of inavolisib plus CDK4/6 inhibitors and letrozole compared to placebo plus CDK4/6 inhibitors and letrozole.

Inclution Criteria

Inclusion Criteria:

Women or men with histologically or cytologically confirmed carcinoma of the breast
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

Exclusion Criteria

Exclusion Criteria:

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

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    450 participants

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