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Trial record 1 of 1 for:    GS-US-592-6238
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Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer (ASCENT-03)

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ClinicalTrials.gov Identifier: NCT05382299
Recruitment Status : Recruiting
First Posted : May 19, 2022
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer PD-L1 Negative Drug: Sacituzumab Govitecan-hziy Drug: Paclitaxel Drug: nab-Paclitaxel Drug: Gemcitabine Drug: Carboplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 20, 2022
Estimated Primary Completion Date : May 2027
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sacituzumab Govitecan-hziy (SG)
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
 Drug: Sacituzumab Govitecan-hziy
Administered intravenously
Other Names:
  • IMMU-132
  • Trodelvy™
  • GS-0132
Active Comparator: Treatment of Physician's Choice (TPC)

Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens:

  • Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
  • Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
  • Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle
 Drug: Paclitaxel
Administered intravenously

Drug: nab-Paclitaxel
Administered intravenously
Other Name: Abraxane®

Drug: Gemcitabine
Administered intravenously

Drug: Carboplatin
Administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Randomization up to approximately 22 months ]
    PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), or death (whichever comes first).


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization up to approximately 57 months ]
    OS is defined as the time from the date of randomization until death due to any cause.

  2. Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1 [ Time Frame: Randomization up to approximately 57 months ]
    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.

  3. Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1 [ Time Frame: Randomization up to approximately 57 months ]
    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).

  4. Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1 [ Time Frame: Randomization up to approximately 57 months ]
    TTR is defined as the time from the date of randomization until the first documentation of CR or PR.

  5. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to approximately 57 months plus 30 days ]
  6. Percentage of Participants Experiencing Clinical Laboratory Abnormalities [ Time Frame: First dose date up to approximately 57 months plus 30 days ]
  7. 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) [ Time Frame: Randomization up to approximately 57 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
    • 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 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05382299


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05382299    
Other Study ID Numbers: GS-US-592-6238
2021-005743-79 ( EudraCT Number )
DOH-27082022-7958 ( Registry Identifier: South African National Clinical Trials Registry )
jRCT2041220122 ( Registry Identifier: Japan Registry of Clinical Trials )
First Posted: May 19, 2022    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs