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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 (ASCENT-03)

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

Iwahori Yuki

Gilead Sciences, K.K.

1-9-2, Marunouchi, Chiyoda-ku, Tokyo

ClinicalTrialGSJ@gilead.com

Operations Clinical

Gilead Sciences K.K.

1-9-2, Marunouchi, Chiyoda-ku, Tokyo

+81-3-6837-0773

JPClinicalOperations@gilead.com

Not Recruiting

Dec. 31, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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.

Both

Triple Negative Breast Cancer / PD-L1 Negative

Patients meeting eligibility will be randomly assigned (1:1) to 1 of 2 arms:
Arm A: Sacituzumab Govitecan 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle.
Arm B: treatment of physician's choice: paclitaxel, nab-paclitaxel, or gemcitabine and
carboplatin.

Treatment of physician's choice (Arm B), which will be selected prior to randomization from 1
of the 3 allowed regimens:
Paclitaxel 90 mg/m^2 intravenously on Days 1, 8, and 15 of a 28-day cycle;
nab-Paclitaxel 100 mg/m^2 intravenously on Days 1, 8, and 15 of a 28-day cycle; or
Gemcitabine 1000 mg/m^2 intravenously plus carboplatin area under the curve (AUC) 2
intravenously on Days 1 and 8 of a 21-day cycle.

No other treatment regimen is permitted and no combination or crossovers of the 3 choices are
permitted. Body surface area dosing (mg/m^2) is based upon body surface area per local standard
of care.

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 57 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).

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

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

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
TTR is defined as the time from the date of randomization until the first documentation of CR or PR.
[ Time Frame: Randomization up to approximately 57 months ]

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)
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.
[ Time Frame: Randomization up to approximately 57 months ]

8. Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30
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 date of death.
[ Time Frame: Randomization up to approximately 57 months ]

+81-54-247-6111

Oct. 21, 2022

No

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