Clinical Trials List
2023-03-11 - 2027-03-01
Phase III
Not yet recruiting3
Recruiting5
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
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Trial Applicant
TAIWAN PSI HEALTH DEVELOPMENT COMPANY LIMITED
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 甘蓉瑜 無
- 高捷妮 無
- Junping Shiau Shiau 無
- Shen Liang Shih 無
- Fang-Ming Chen 無
- Chung-Liang Li 無
- Chieh-Han Chuang 無
- 巫承哲 無
- 高理鈞 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 張端瑩 無
- 黃柏翔 無
- 楊明翰 無
- 林季宏 無
- WEI-LI MA 無
- 羅喬 無
- 陳怡君 無
- MING-YANG WANG 無
- Wei-Wu Chen 無
- 李佳真 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- HUI-WEN LIU 無
- Wei-Hong Cheng 無
- 蘇智銘 無
- Yao-Yu Hsieh 無
- KA-WAI TAM 無
- Tsu-Yi Chao 無
- 莊博雅 無
- 廖立民 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chih-Jung Chen 無
- Yao-Chung Wu 無
- 黃至豪 無
- HWEI-CHUNG WANG 無
- Chen-Teng Wu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 邱仁輝 無
- Ta-Chung Chao 無
- 馮晉榮 無
- Chi-Cheng Huang 無
- 陳彥蓁 無
- 賴亦貞 無
- 林燕淑 無
- Jiun-I Lai 無
- 陳柏方 無
- Yi-Fang Tsai 無
- Chun-Yu Liu 無
- 鄭涵方 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
main:
- Overall PFS curve using the Kaplan-Meier (KM) method, where PFS is defined as the time from random assignment to death or first confirmed radiographic disease progression, whichever occurs first; as determined by Blinded Independent Central Review (BICR), and confirmed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria) elapsed time
Trial 2 (PIK3CA mutations)
main:
- Overall PFS curve using the KM method, where PFS is defined as the time from random assignment to death or first confirmed radiographic disease progression (whichever occurs first; as judged by BICR and confirmed by RECIST version 1.1 criteria) time
Inclution 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
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
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Taiwan
34 participants
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Global
701 participants
