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Clinical Trials List

Protocol NumberCELC-G-302
NCT Number(ClinicalTrials.gov Identfier)NCT06757634
Active

2025-06-06 - 2028-09-13

Phase III

Recruiting7

ICD-10C50.011

Malignant neoplasm of nipple and areola, right female breast

ICD-10C50.012

Malignant neoplasm of nipple and areola, left female breast

ICD-10C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.0

Malignant neoplasm of female breast, nipple and areola

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator YEN-SHEN LU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSU-YI CHAO Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Liang-Chih Liu Division of General Surgery
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳守棟 Division of General Surgery
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Feng Hou Division of General Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kuo-Ting Lee
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Breast Cancer

Objectives

Safety Introduction Primary Objective: ● Evaluate the safety and tolerability of gedatolisib in combination with ribociclib and fulvestrant in HR+/HER2- ABC patients who have not previously received any systemic anticancer therapy for ABC. ● Confirm the Phase 3 recommended dose (RP3D) of gedatolisib in combination with ribociclib and fulvestrant. Secondary Objective: ● Efficacy is assessed based on objective response rate (ORR), duration of response (DOR), and progression-free survival (PFS) at 6 and 12 months. Phase 3 (Each objective applies to cohorts 1 and 2, respectively) Primary Objective: ● Compare the efficacy of gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant (Group A) versus fulvestrant in combination with a CDK4/6 inhibitor (Group B) based on PFS assessment (assessed according to RECIST version 1.1, by blinded independent central review). Key Secondary Objective: ● Based on overall survival (OS) assessment, compare the efficacy among groups. ● Compare the safety and tolerability among groups.

Test Drug

Infusion fluid

Active Ingredient

Gedatolisib

Dosage Form

27C

Dosage

-

Endpoints

Safety Run-In
•Type, incidence, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5.0), seriousness, and relationship to study medications of AEs and any laboratory abnormalities
•Incidence of dose-limiting toxicities (DLTs), AEs graded according to NCI CTCAE v5.0, and dose reductions or modifications

Phase 3 Study (Each Objective Applies to Cohorts 1 and 2 Independently)
•Overall PFS using the KM method, where PFS is defined as the time from randomization to death or the first documented radiologically confirmed disease progression, whichever occurs first, using RECIST v1.1, as determined based on BICR

Inclution Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- breast cancer
Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue for the duration of the study.
Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment.
Progression of disease during or within 12 months of completing (neo)adjuvant ET.
Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.
Permitted prior therapies:

(neo)adjuvant fulvestrant or any selective ER degrader only if the treatment duration < 6 months
(neo)adjuvant chemotherapy
(neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i
Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with evaluable bone-only disease are not eligible. Patients with bone-only disease that has lytic or mixed lytic/blastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Life expectancy of at least >6 months.
Adequate bone marrow, hepatic, renal and coagulation function.

Exclusion Criteria

Exclusion Criteria:

Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study.
Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
Prior treatment with systemic anticancer therapy for ABC
Subjects with type 1 diabetes
Known and untreated, or active, brain or leptomeningeal metastases
History of clinically significant cardiovascular abnormalities
History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    674 participants

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