Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

NCT05633654
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,514
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Lead sponsor
Gilead Sciences
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Start date
2022-12-12
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Number of sites
356
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Summary
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
clinicaltrials.gov
Short title
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
clinicaltrials.gov
Official title
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2031-08-01
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First posted
2022-12-01
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Registry last updated
2026-07-15
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Primary completion date
2027-06-01
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Start date
2022-12-12
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Participants
1,514
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Participant count basis
Estimated
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Planned participants
1,514
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Protocol amendments
6
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Number of sites
356
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Gilead Sciences
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05633654
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ClinicalTrials.gov ID
NCT05633654
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Invasive Disease-free Survival (iDFS)

    Timeframe: Up to 60 months

    iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.

  1. Overall Survival (OS)

    Timeframe: Up to 96 months

    OS is defined as the time from the date of randomization until death due to any cause.

  2. Distant Disease-free Survival (dDFS)

    Timeframe: Up to 60 months

    dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer.

  3. Recurrence-free Survival (RFS)

    Timeframe: Up to 60 months

    RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence.

  4. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Timeframe: First dose date up to 38 months plus 30 days

  5. Percentage of Participants Experiencing Laboratory Abnormalities

    Timeframe: First dose date up to 38 months plus 30 days

  6. Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores

    Timeframe: Up to 60 months

    TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:

    • TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).

  • Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.

  • Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

  • Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment.

  • Adequate organ function.

Key Exclusion Criteria:

  • Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
  • Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.
  • Evidence of recurrent disease following preoperative therapy and surgery.
  • Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
  • Individuals with germline breast cancer gene (BRCA) mutations.
  • Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%
  • Active serious infections requiring anti-microbial therapy.

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

Sources for eligibility
clinicaltrials.gov

  • Alabama OncologyBirmingham, United StatesRecruiting
  • Clearview Cancer InstituteHuntsville, United StatesRecruiting
  • Palo Verde Hematology OncologyGlendale, United StatesRecruiting
  • Mayo Clinic HospitalPhoenix, United StatesWithdrawn
  • Arizona Oncology AssociatesPrescott Valley, United StatesWithdrawn
  • Alta Bates Summit Medical CenterBerkeley, United StatesRecruiting
  • Community Cancer InstituteClovis, United StatesWithdrawn
  • PIH Health Whittier HospitalDowney, United StatesRecruiting
  • Compassionate Cancer Care Medical Group - IncFountain Valley, United StatesRecruiting
  • Los Angeles Cancer NetworkLos Angeles, United StatesRecruiting
  • USC Norris Comprehensive Cancer CenterLos Angeles, United StatesWithdrawn
  • Cedars-Sinai Cancer at Beverly HillsLos Angeles, United StatesRecruiting
  • Hoag Memorial Hospital PresbyterianNewport Beach, United StatesRecruiting
  • Emad Ibrahim, MD, INCRedlands, United StatesWithdrawn
  • Sutter Institute for Medical ResearchSacramento, United StatesRecruiting
  • City of Hope (Duarte)San Francisco, United StatesRecruiting
  • UCSF Medical CenterSan Francisco, United StatesRecruiting
  • Sansum ClinicSanta Barbara, United StatesRecruiting
  • Stockton Hematology Oncology Medical GroupStockton, United StatesRecruiting
  • University of Colorado Cancer CenterAurora, United StatesWithdrawn
  • Norwalk HospitalDanbury, United StatesWithdrawn
  • Stamford HospitalStamford, United StatesRecruiting
  • MedStar Georgetown University HospitalWashington D.C., United StatesRecruiting
  • MedStar Washington Hospital CenterWashington D.C., United StatesRecruiting
  • Morton Plant Hospital - Bay CareClearwater, United StatesWithdrawn

And 331 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-512279-10
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Collaborators (3)

Lead sponsors (1)

Conditions (1)

Targets (4)