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

Clinical Trials List

Protocol NumberEVER-132-002
NCT Number(ClinicalTrials.gov Identfier)NCT04639986
Active

2020-09-24 - 2025-12-31

Phase III

Not yet recruiting6

Recruiting2

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 3 Asian Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With HR+/ HER2- Metastatic Breast Cancer (MBC) Who Have Failed at Least 2 Prior Chemotherapy Regimens

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Everest Medicines II (HK) Limited

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Wei-Pang Chung Division of Hematology & Oncology
National Taiwan 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 Not yet 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 Not yet recruiting

Principal Investigator HWEI-CHUNG WANG Division of General Surgery
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 陳訓轍 Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet 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 Not yet 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

Audit

None

Condition/Disease

Metastatic Breast Cancer

Objectives

To assess and compare the efficacy of sacituzumab govitecan versus TPC as measured by progression-free survival (PFS) (as determined by an independent reviewing committee [IRC] using the Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST v 1.1]) in subjects with hormonal receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2−) metastatic breast cancer (MBC) after at least 2, and no more than 4, prior chemotherapy regimens for MBC.

Test Drug

Sacituzumab govitecan

Active Ingredient

Sacituzumab govitecan (IMMU-132)

Dosage Form

Lyophilizate for solution for infusion

Dosage

180

Endpoints

•Primary endpoint:
-PFS measuring from the date of randomization until the date of disease progression (PD) or death, whichever occurs earlier. Disease progression will be determined according to RECIST v 1.1 by an IRC.
•Secondary endpoint:
-Overall survival from the date of randomization to death.
-Objective response rate by IRC. Objective response includes CR and PR.
-Duration of response by IRC, from the date of first onset of tumor response (CR or PR) to PD or death, whichever occurs earlier.
-CBR by IRC. clinical benefit includes CR, PR, and SD with a duration ≥ 6 months.
•Other endpoints: Trop-2 expression, potential Blood and tumor biomarkers, ADA of sacituzumab govitecan, UGT1A1 genotype.

Inclution Criteria

1)Male or female, 18 (20 in Taiwan) years of age or older who provided written informed consent.
2)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3)Documented evidence of HR+/HER2− MBC confirmed histologically or cytologically (local laboratory) with the most recently available or newly obtained tumor biopsy (preferably within 12 months prior to consent) from a locally recurrent or metastatic site(s).
4)Availability of archival tumor tissue in a formalin-fixed, paraffin embedded (FFPE) block or 10 unstaining slides ( preferably within 12 months prior to consent) or newly acquired biopsy (FFPE block or 10 unstaining slides) from a metastatic site. Note: bone biopsies are not allowed.
5)Refractory or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC. Adjuvant or neoadjuvant therapy for early stage disease will qualify as one of the required prior regimens if the development of unresectable, locally advanced or metastatic disease occurred within a 12-month period after completion of the chemotherapy. Note: treatment of bone metastases (eg, bisphosphonates, denosumab, etc) and hormonal therapy are not counted as prior systemic chemotherapy for advanced disease.
6)Should have been previously treated with:
o At least 1 taxane in any setting.
o At least 1 prior anticancer hormonal treatment in any setting.
7)Eligible for one of the chemotherapy options listed in the TPC arm.
8)Documented radiographic PD (by computed tomography [CT] or magnetic resonance imaging [MRI]) after the most recent anticancer therapy.
9)Measurable disease by CT or MRI in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.
10)Adequate bone marrow, hepatic, and renal function.
11)Recovered from all prior treatment-related toxicities to Grade 1 or less by CTCAE v 5.0 (except alopecia or stable sensory neuropathy that may be Grade 2 or less). Subjects with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.

Exclusion Criteria

1)Previous treatment with topoisomerase 1 inhibitors as a free form or as other formulations.
2)Subjects who have known brain metastases.
3)Have an active second malignancy within 3 years prior to providing informed consent (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ).
4)Subjects known to be human immunodeficiency virus (HIV) positive.
5)Subjects with active hepatitis B virus (HBV), or hepatitis C virus infection (measurable viral RNA load with polymerase chain reaction). In subjects with a history of HBV, hepatitis B core antibody (HBcAb) testing is required and if positive, then HBV DNA testing will be performed and if quantitative positive the subject will be excluded.
6)Known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months before C1D1 of first dose or clinically significant cardiac arrhythmia (other than stable controlled atrial fibrillation) requiring anti-arrhythmia therapy or left ventricular ejection fraction < 50%.
7)Known history of clinically significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness present within 6 months before C1D1.
8)Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease), clinically significant gastrointestinal (GI) bleeding, intestinal obstruction, or GI perforation within 6 months before C1D1.
9)Active serious infection requiring systemic antibiotic use within 7 days before C1D1.
10)High dose systemic corticosteroid usage at least 2 weeks before C1D1. However, low dose corticosteroids ≤ 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks.
11)Scheduled surgery during the study, other than minor surgery which would not delay study treatment.
12)Subjects who have received a live vaccine within 30 days before C1D1.
13)Other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
14)Known hypersensitivity or intolerance to either of the study treatments or any of the excipients.
15)Treatment with chemotherapy, or radiation, or small molecule targeted therapy within 2 weeks, or biological therapy within 4 weeks (or 5 half-lives of biologic, whichever is longer) prior to C1D1.
16)Currently being treated in another clinical study or used any investigational drug or device either within 5 half-lives or 4 weeks before C1D1 (whichever is longer). Or receiving any medication prohibited in combination with the study treatment(s) as described in the respective product labels, unless medication was stopped within 7 days before C1D1.
17)Women who are pregnant or lactating.
18)Women of childbearing potential or fertile men unwilling to use highly effective contraception during the study, and up to 6 months after treatment discontinuation in women of childbearing potential and 3 months in men post last study treatment.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    330 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