Brief Summary
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
Brief Title
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-833-445-3230 (GILEAD-0)
Central Contact Email
GileadClinicalTrials@gilead.com
Completion Date
Completion Date Type
Estimated
Conditions
Triple Negative Breast Cancer
PD-L1 Negative
Eligibility Criteria
Key Inclusion Criteria:
* Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
* Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
* Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
* Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
* Individuals presenting with de novo metastatic TNBC are eligible
* Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* 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
* Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
Key Exclusion Criteria:
* Positive serum pregnancy test or women who are lactating
* Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
* Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
* May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
* Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
* Active second malignancy
* Active serious infection requiring antibiotics
* Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
* Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
* Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
* Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
* Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
* Individuals presenting with de novo metastatic TNBC are eligible
* Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* 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
* Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
Key Exclusion Criteria:
* Positive serum pregnancy test or women who are lactating
* Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
* Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
* May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
* Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
* Active second malignancy
* Active serious infection requiring antibiotics
* Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion Criteria
Inclusion Criteria:
* Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
* Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
* Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
* Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
* Individuals presenting with de novo metastatic TNBC are eligible
* Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* 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
* Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
Inclusion/
* Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
* Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
* Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
* Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
* Individuals presenting with de novo metastatic TNBC are eligible
* Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* 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
* Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
Inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05382299
Org Class
Industry
Org Full Name
Gilead Sciences
Org Study Id
GS-US-592-6238
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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
Primary Outcomes
Outcome Description
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), or death (whichever comes first).
Outcome Measure
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Outcome Time Frame
Randomization up to approximately 57 months
Secondary Ids
Secondary Id
2021-005743-79
Secondary Id
DOH-27082022-7958
Secondary Id
jRCT2041220122
Secondary Id
CTR20234162
Secondary Id
2023-504195-14
Secondary Outcomes
Outcome Description
OS is defined as the time from the date of randomization until death due to any cause.
Outcome Time Frame
Randomization up to approximately 57 months
Outcome Measure
Overall Survival (OS)
Outcome Description
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Outcome Time Frame
Randomization up to approximately 57 months
Outcome Measure
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Outcome Description
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD or death from any cause (whichever comes first).
Outcome Time Frame
Randomization up to approximately 57 months
Outcome Measure
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Outcome Description
TTR is defined as the time from the date of randomization until the first documentation of CR or PR.
Outcome Time Frame
Randomization up to approximately 57 months
Outcome Measure
Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
Outcome Time Frame
First dose date up to approximately 57 months plus 30 days
Outcome Measure
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Outcome Time Frame
First dose date up to approximately 57 months plus 30 days
Outcome Measure
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Outcome Description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) to assess 15 scales; 1 global health status/quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social), and 9 symptom/item scales(fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Outcome Time Frame
Randomization up to approximately 57 months
Outcome Measure
Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30).
Outcome Description
TTD is defined as the time between the date of randomization and the date of assessment at which a patient experienced a deterioration (≥ 10 points deterioration from baseline in the fatigue scale) or death.
Outcome Time Frame
Randomization up to approximately 57 months
Outcome Measure
Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jesus Anampa Mesias
Investigator Email
janampa@montefiore.org
Investigator Phone
718-920-4826/718-405-8505/646-757-0997