問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberCELC-G-301
NCT Number(ClinicalTrials.gov Identfier)NCT05501886
Active

2023-03-11 - 2027-03-01

Phase III

Recruiting8

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

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

  • Trial Applicant

    TAIWAN PSI HEALTH DEVELOPMENT COMPANY LIMITED

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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 JO-PAI CHEN Division of Hematology & Oncology
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

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 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

Condition/Disease

Breast Cancer

Objectives

This is a phase 3, open-label, randomized, two-part clinical trial designed to evaluate the efficacy and safety of gedatolisib in combination with palbociclib and fulvestrant. The trial comprises two separate trials differentiated by PIK3CA mutation status. PIK3CA mutation status will be assessed using Therascreen® PIK3CA RGQ polymerase chain reaction (PCR). Based on confirmed PIK3CA mutation status, participants will be manually assigned to either Trial 1 (PIK3CA WT) or Trial 2 (PIK3CA MT). These two trials will be randomized separately. Enrollment for Trial 1 is expected to be completed prior to Trial 2. Once enrollment for Trial 1 is complete, only patients with PIK3CA MT disease will be eligible for Trial 2. The primary objective of Trial 1 is to evaluate whether gedatolisib combined with palbociclib and fulvestrant, and gedatolisib combined with fulvestrant, provides better overall progression-free survival (PFS) compared to fulvestrant in HR+/HER2-/PIK3CA WT advanced breast cancer patients who have previously received CDK4/6 inhibitors and nonsteroidal anti-inflammatory drug (AI) therapy. Trial 1 will also evaluate gedatolisib combined with fulvestrant to characterize the effects of gedatolisib and palbociclib. Approximately 351 participants will be recruited and randomly assigned in a 1:1:1 ratio to group A, B, or C, stratified according to the presence/absence of organ metastases (lung/liver) (yes/no), time elapsed before radiological disease progression during the previous therapy period (<= or > 6 months), and geographic region (North America or other parts of the world). For subjects randomly assigned to group C in Trial 1, upon experiencing radiographically confirmed disease progression as assessed by the trial administrator, there will be an opportunity to switch to either group A or group B (selective) at the principal investigator's choice. The date of radiographically confirmed disease progression will be considered the new baseline. Switching treatment should commence within 4 weeks of radiographically confirmed disease progression, and all assessments will continue from C1D1 according to the assessment schedule outlined in the trial protocol (e.g., response assessments will continue every 8 weeks for the first 12 months from the date of the first dose in group A or group B, and then every 12 weeks thereafter). After switching, subjects should continue to meet the criteria for retreatment. All treatments and follow-up appointments for subjects switched to groups A and B must adhere to the treatment schedule in Table 2 of the trial protocol. The primary objective of Trial 2 is to evaluate whether gedatolisib plus palbociclib and fulvestrant provides better overall progression-free survival (PFS) compared to alpelisib plus fulvestrant in HR+/HER2-/PIK3CA MT advanced breast cancer patients who have previously received CDK4/6 inhibitors and nonsteroidal anti-inflammatory (AI) therapy. 350 participants will be recruited and randomly assigned in a 3:3:1 ratio to groups D, E, or F, stratified according to the presence/absence of organ metastases (lung/liver), time elapsed before radiological disease progression during the previous therapy (<= or > 6 months), and geographic location (North America or other parts of the world).

Test Drug

注射劑

Active Ingredient

Gedatolisib

Dosage Form

270

Dosage

180 mg / vial

Endpoints

Trial 1 (PIK3CA Wild-type)

Primary:

- Overall PFS curves using the Kaplan-Meier (KM) method, where PFS is defined as the time elapsed from randomization to death or first confirmed radiation-induced disease progression (whichever occurs first; determined by blinded independent central review (BICR) and confirmed by RECIST version 1.1 criteria).

Trial 2 (PIK3CA Mutant)

Primary:

- Overall PFS curves using the KM method, where PFS is defined as the time elapsed from randomization to death or first confirmed radiation-induced disease progression (whichever occurs first; determined by BICR and confirmed by RECIST version 1.1 criteria).

Inclution Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of metastatic or locally advanced 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 on it for the duration of the study.
Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatment
Confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive, as per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standards
Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
Subject must have documentation of radiological disease progression on or after the last prior treatment and also have radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment. Subjects with bone only disease must have lytic or mixed lytic/blastic lesions that can be accurately assessed; bone only blastic lesions with no soft tissue component is not allowed.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Life expectancy of at least 3 months
Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI)
Adequate bone marrow, hepatic, renal and coagulation function

Exclusion Criteria

Exclusion Criteria:

History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥3 years
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 chemotherapy and antibody drug conjugates for advanced disease is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted)
More than 2 lines of prior endocrine therapy treatment
Bone only disease that is only blastic with no soft tissue component
Subjects with type 1 diabetes or uncontrolled type 2 diabetes
Known and untreated, or active, brain or leptomeningeal metastases

a. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to enrollment

Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term
History of clinically significant cardiovascular abnormalities such as: Congestive heart failure (New York Heart Association (NYHA) classification ≥ II within 6 months of study entry

Myocardial infarction within 12 months of study entry
History of any uncontrolled (or untreated) clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months
Uncontrolled hypertension defined by systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication (initiation or adjustment of antihypertensive medication[s] is allowed prior to screening)
Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:

i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, or history of clinically significant/symptomatic bradycardia
ii. On screening, inability to determine the corrected QT interval using Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF >480 msec (determined by mean of triplicate ECGs at screening)
Known hypersensitivity to the study drugs or their components
Pregnant or breast-feeding women
Concurrent participation in another interventional clinical trial

Subjects must agree not to participate in another clinical trial (other than observational) at any time during participation in VIKTORIA-1.

The Estimated Number of Participants

  • Taiwan

    34 participants

  • Global

    701 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB