Clinical Trials List
2023-06-30 - 2029-02-28
Phase III
Not yet recruiting10
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
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Trial Applicant
GILEAD SCIENCES HONG KONG 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
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
- 周旭桓 無
- Mengting Peng 無
- Yung-Chang Lin 無
- Chi-Chang Yu 無
- 沈士哲 無
- 張潤忠 無
- Chan-Keng Yang 無
- Wen-Chi Shen 無
- Shin-Cheh Chen 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
- 甘蓉瑜 無
- 高捷妮 無
- Junping Shiau Shiau 無
- 巫承哲 無
- 高理鈞 無
- Chung-Liang Li 無
- Chieh-Han Chuang 無
- Shen Liang Shih 無
- Fang-Ming Chen 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 林季宏 無
- Wei-Wu Chen 無
- 楊明翰 無
- WEI-LI MA 無
- 黃柏翔 無
- MING-YANG WANG 無
- 張端瑩 無
- 羅喬 無
- 李佳真 無
- 陳怡君 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 馮晉榮 無
- Yi-Fang Tsai 無
- 鄭涵方 無
- 林燕淑 無
- Chi-Cheng Huang 無
- 賴亦貞 無
- 陳柏方 無
- 邱仁輝 無
- Ta-Chung Chao 無
- Jiun-I Lai 無
- 陳彥蓁 無
- Chun-Yu Liu 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Wei-Hong Cheng 無
- 莊博雅 無
- Yao-Yu Hsieh 無
- KA-WAI TAM 無
- HUI-WEN LIU 無
- 蘇智銘 無
- Tsu-Yi Chao 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
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
Able to understand and give written informed consent.
Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site.
Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site.
Documented evidence of HER2- status.
Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria.
Candidate for the first chemotherapy in the locally advanced or metastatic setting.
Eligible for capecitabine, nab-paclitaxel, or paclitaxel.
Individuals must have at least one of the following:
Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting.
Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting.
Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access a CDK 4/6 inhibitor) in the metastatic setting.
Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting.
Individuals may have received prior targeted therapies, including but not limited to PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations), or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies.
Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
Demonstrates adequate organ function.
Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.
Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
Current enrollment in another clinical study and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer.
Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization.
Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I.
Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
Have an active second malignancy.
Have an active serious infection requiring antibiotics.
Have active hepatitis B virus (HBV) or hepatitis C virus (HCV).
Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth.
The Estimated Number of Participants
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Taiwan
90 participants
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Global
654 participants
