Clinical Trials List
2023-05-01 - 2027-05-31
Phase III
Not yet recruiting9
Recruiting4
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 Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
Gilead Sciences, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Yao-Chung Wu 無
- Chih-Jung Chen 無
- HWEI-CHUNG WANG 無
- 黃至豪 無
- Chen-Teng Wu 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Shang-Hung Chen 無
- Yao-Lung Kuo 無
- Wei-Pang Chung 無
- Jui-Hung Tsai 無
- Chun-Hui Lee 無
- Zhu-Jun Loh 無
- 楊舜如 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chi-Chang Yu 無
- Mengting Peng 無
- 沈士哲 無
- Wen-Chi Shen 無
- 何蕙余 無
- Shin-Cheh Chen 無
- Yung-Chang Lin 無
- 阮昱翔 無
- 周旭桓 無
- Chan-Keng Yang 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Yu-Li Su 無
- 郭明濬 無
- Tai-Jan Chiu 無
- 黃詩喻 無
- Shau-Hsuan Li 無
- 陳彥豪 無
- 林昶廷 無
- 陳彥仰 無
- 吳佳哲 無
- 李易濰 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 洪朝明 無
- 蔡郁棻 無
- Meng-Jer Hsieh 無
- 裴松南 無
- 李蕙鳴 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- ZHENG-WEI ZHOU Division of General Surgery
- 王國鐘 Division of General Surgery
- Huey-En Tzeng Division of General Surgery
- 楊陽生 Division of General Surgery
- 楊捷儒 無
- 林慈恩 Division of General Surgery
- Kuan-Der Lee Division of General Surgery
- I-Chen Tsai Division of General Surgery
- HSIN-CHEN LIN Division of General Surgery
- 劉佳樺 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
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 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
until the date of objective progressive disease (PD), as
assessed by BICR per Response Evaluation Criteria in Solid
Tumors (RECIST) Version 1.1, or death (whichever comes
first).
Inclution Criteria
2) Patients with locally advanced, inoperable, or metastatic TNBC whose advanced disease has not previously received systemic therapy and whose tumors are PD-L1 negative at screening. Alternatively, for patients whose tumors are PD-L1 positive at screening, they will also be eligible if they receive an anti-planned cell death (ligand) 1 (anti-PD-[L]1) inhibitor (i.e., a checkpoint inhibitor) during adjuvant chemotherapy or preoperative adjuvant chemotherapy.
a) Patients must have completed treatment for stage I-III breast cancer (if applicable), and at least 6 months must have elapsed between the completion of radical treatment (e.g., the date of primary breast cancer surgery, or the date of the last (preoperative) adjuvant chemotherapy [including anti-PD-(L)1 therapy], whichever occurred later) and the first recorded local or distant disease recurrence. Postoperative radiotherapy dates are not included in this calculation.
i) Patients who received adjuvant chemotherapy with taxane, gemcitabine, or platinum (preoperative) are eligible for the same type of chemotherapy (taxane or gemcitabine/carboplatin) if ≥ 12 months have elapsed between the completion of radical treatment (e.g., the date of primary breast cancer surgery, or the date of the last adjuvant chemotherapy, whichever occurred later) and the first recorded local or distant disease recurrence.
ii) Enrolled patients should have received prior treatment with anthracyclines in adjuvant chemotherapy (preoperative), or be deemed ineligible for anthracyclines by their attending physician.
b) Patients newly diagnosed with metastatic TNBC at presentation are eligible for this trial.
c) TNBC status and tumor PD-L1 composite positive score (CPS) will be confirmed by a central laboratory based on recent or retained tumor specimens. Patients must have histologically or cytologically confirmed TNBC, defined as negative for estrogen receptor (ER), luteinizing hormone receptor, and human epidermal growth hormone receptor type 2 (HER2) according to current American Society of Clinical Oncology (ASCO) or College of American Pathologists (CAP) guidelines. Patients initially diagnosed with hormone receptor-positive or HER2-positive breast cancer must have TNBC confirmed by a central laboratory examination of tumor tissue sections obtained from locally recurrent or distant metastatic tumors before admission. A tumor composite positive score (CPS) < 10, assessed using PD-L1 immunohistochemical staining (IHC) 22C3 assay, is required for eligibility. Alternatively, patients with a tumor CPS ≥ 10 who received anti-PD-(L)1 inhibitors (i.e., checkpoint inhibitors) during adjuvant or preoperative adjuvant chemotherapy will also be eligible. d) Patients must have disease measurable by computed tomography (CT) or MRI scans, as assessed by a local laboratory according to the Responsive Criteria in Solid Tumor Response (RECIST) version 1.1. Tumor lesions located in previously irradiated areas are considered measurable if the lesion has shown significant progression since radiotherapy.
3) A representative formalin-fixed paraffin-embedded (FFPE) tumor specimen (preferably) is provided, or at least 20 to 25 freshly cut, unstained slides from newly collected tissue sections (preferably) or preserved tissue blocks are available for central laboratory testing of ER, progesterone receptor, HER2, PD-L1, and other biomarkers. If preserved tissue is unavailable, tissue sections must be collected at the baseline period, after the patient submits written informed consent, and before the first dose of trial treatment. Fine-needle aspiration and bone sections are not suitable specimens. Note: The quality of the tumor tissue must be confirmed by a central laboratory. If the provided specimen is insufficient to meet the evaluation requirements, an additional tumor specimen may be required.
4) East Coast Cancer Research Cooperative (ECOG) Performance Status Score: 0 or 1.
5) Life expectancy: ≥ 3 months.
6) Recovery from major surgery: ≥ 2 weeks.
7) Adequate blood counts (hemoglobin ≥ 9 g/dL, neutrophil count (ANC) ≥ 1500/mm3, and platelets ≥ 100,000/μL) without transfusion or growth factor support within 2 weeks of starting the trial treatment. 8) Adequate liver function (bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the ULN, or ≤ 5 times the ULN if liver metastasis is known, and serum albumin > 3 g/dL).
9) Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault formula.
10) International normalized clotting time ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times the ULN, except for patients currently receiving therapeutic anticoagulation therapy.
11) Male and female patients of fertility and engaging in heterosexual activity must agree to use the contraceptive method specified in the trial plan. 12) Patients infected with human immunodeficiency virus (HIV) must be receiving antiretroviral therapy (ART), and their HIV infection/disease must be well controlled as defined below:
a) Patients receiving ART must have a CD4+ T cell count ≥ 350 cells/mm3 at screening.
b) Patients receiving ART must have achieved and maintained viral suppression, defined as an HIV RNA concentration below 50 copies/mL or the lower limit of detection (LOD) at screening, confirmed by locally available assays, and maintained for at least 12 weeks prior to screening.
c) Patients receiving ART must maintain a stable course of treatment without changes to medication or dosage adjustments, and this must continue for at least 4 weeks prior to starting the trial (Day 1).
d) The ART regimen must not contain any medications that interfere with SN-38 metabolism.
Exclusion Criteria
1) Positive serum pregnancy test or breastfeeding woman.
2) Known hypersensitivity or allergy to Sacituzumab Govitecan and/or physician-selective treatment (TPC) chemotherapy options (e.g., nab-paclitaxel, paclitaxel, gemcitabine, or carboplatin), its metabolites, or dosage form excipients, or severe (≥ Grade 3) hypersensitivity or allergy.
3) Requires ongoing treatment with any prohibited medication, or has previously used any prohibited medication.
4) Patients must not have received systemic anticancer therapy within the past 6 months, or radiation therapy within the 2 weeks prior to enrollment. Patients experiencing adverse events (AEs) due to previously administered medications must have recovered by the time of trial entry (i.e., > Grade 2 is considered unrecovered). • Note: Patients with any grade of neuropathy or hair loss are not eligible for this criterion and will be eligible for the trial.
• Note: If a patient has undergone major surgery, the toxicity and/or complications from the interventional procedure must have fully recovered before starting treatment.
5) Patients must not participate in trials using investigational drugs or investigational medical devices within 4 weeks prior to randomization. Patients participating in observational trials are eligible.
6) Previous treatment with a Topoisomerase 1 inhibitor or an antibody-drug complex containing a Topoisomerase inhibitor.
7) Having a second active malignancy.
Note: Patients with a history of malignancy who have received complete treatment and have no evidence of active cancer for at least 3 years prior to enrollment, or whose tumor is surgically curable and has a low risk of recurrence (e.g., non-melanoma skin cancer, histologically confirmed completely resected carcinoma in situ, or equivalent), may be eligible for inclusion.
8) Known progressive central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with brain metastases who have previously received treatment are eligible to participate if their CNS condition has remained stable for at least 4 weeks prior to enrollment (defined as at least two post-treatment brain imaging assessments showing radiographic stability; one of which is performed during screening), all neurological symptoms have returned to baseline, there is no evidence of new brain metastases or enlargement of brain metastases, and their medication is ≤ 10 mg/day of prednisone or equivalent, maintaining clinical stability for at least 2 weeks (except for those receiving chemotherapy). All patients with carcinomatous meningitis, regardless of clinical stability, are excluded.
9) Meeting any of the following cardiac conditions:
a) Myocardial infarction or unstable angina within the past 6 months.
b) History of severe ventricular arrhythmias (i.e., ventricular tachycardia or ventricular fibrillation), high-degree atrioventricular block, or other arrhythmias requiring antiarrhythmic drug therapy (excluding atrial fibrillation well controlled with antiarrhythmic drugs); history of QT interval prolongation.
c) New York Heart Association grade III or higher congestive heart failure or a known left ventricular ejection fraction < 40%.
10) Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within the past 6 months.
11) Active severe infection requiring antibiotics.
12) History of HIV-1 or 2 positivity with Kaposi's sarcoma and/or multicentric Karstmann disease.
13) Possessing active hepatitis B virus (HBV) (defined as a positive hepatitis B surface antigen (HBsAg) test) or hepatitis C virus (HCV).
a) For patients with a history of HBV infection, hepatitis B core antibody testing should be performed at screening. If positive, hepatitis B deoxyribonucleic acid (DNA) testing will be performed. If active HBV infection is ruled out, the patient is eligible.
b) Patients with positive HCV antibodies but undetectable HCV viral load are eligible.
14) Having other coexisting neurological or psychiatric conditions, according to the trial administrator, that may obscure trial interpretation or hinder completion of trial procedures and follow-up examinations.
15) Having received an activated vaccine within 30 days prior to randomization.
The Estimated Number of Participants
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Taiwan
39 participants
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Global
540 participants
