Back to resultsStudy 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)
Primary Purpose
Triple Negative Breast Cancer
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sacituzumab govitecan-hziy (SG)
Pembrolizumab
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring OptimICE-RD, AFT-65
Eligibility Criteria
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 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. 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 known 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.
Sites / Locations
- Alabama OncologyRecruiting
- Clearview Cancer InstituteRecruiting
- Palo Verde Hematology OncologyRecruiting
- Compassionate Cancer Care Medical Group - IncRecruiting
- Los Angeles Cancer NetworkRecruiting
- Emad Ibrahim, MD, INCRecruiting
- UCSF Medical CenterRecruiting
- Stamford HospitalRecruiting
- Cancer Specialists of North FloridaRecruiting
- Jupiter Medical CenterRecruiting
- Midland Florida Clinical Research Center, LRecruiting
- Orlando HealthRecruiting
- Mount Sinai Health SystemRecruiting
- Piedmont Cancer InstituteRecruiting
- Northside HospitalRecruiting
- Northwest Georgia Oncology Centers, PCRecruiting
- Edward HospitalRecruiting
- Edward H. Kaplan MD & Associates - Hematology/Oncology of the North ShoreRecruiting
- IU Health Arnett HospitalRecruiting
- Mercy Medical CenterRecruiting
- Norton Healthcare, Inc.Recruiting
- Mercy HealthRecruiting
- Mary Bird Perkins Cancer CenterRecruiting
- New England Cancer SpecialistsRecruiting
- Medstar Franklin Square Medical CenterRecruiting
- American Oncology Partners of Maryland, PARecruiting
- Regional Cancer Care Associates LLCRecruiting
- Summit Medical Group, P.A.Recruiting
- Rutgers HealthRecruiting
- San Juan Oncology AssociatesRecruiting
- Laura and Isaac Perlmutter Cancer CanterRecruiting
- New York Cancer and Blood SpecialistsRecruiting
- Stony Brook MedicineRecruiting
- Clinical Research AllianceRecruiting
- Lancaster General HealthRecruiting
- Reading Hospital and Medical CenterRecruiting
- Monument Health Cancer Care InstituteRecruiting
- Avera Cancer InstituteRecruiting
- University of TennesseeRecruiting
- MD Anderson Cancer CenterRecruiting
- Northwest Medical Specialties, PLLCRecruiting
- Medical Oncology AssociatesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sacituzumab govitecan-hziy (SG) + Pembrolizumab
Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine
Arm Description
Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.
Participants will receive one of the following TPC regimens determined prior to randomization: Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.
Outcomes
Primary Outcome Measures
Invasive Disease-free Survival (iDFS)
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.
Secondary Outcome Measures
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause.
Distant Disease-free Survival (dDFS)
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.
Recurrence-free Survival (RFS)
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.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Laboratory Abnormalities
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
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.
Full Information
NCT ID
NCT05633654
First Posted
November 21, 2022
Last Updated
October 10, 2023
Sponsor
Gilead Sciences
Collaborators
Alliance Foundation Trials, LLC.
1. Study Identification
Unique Protocol Identification Number
NCT05633654
Brief 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
Acronym
ASCENT-05
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
August 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
Collaborators
Alliance Foundation Trials, LLC.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
OptimICE-RD, AFT-65
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1514 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sacituzumab govitecan-hziy (SG) + Pembrolizumab
Arm Type
Experimental
Arm Description
Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles.
Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.
Arm Title
Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine
Arm Type
Active Comparator
Arm Description
Participants will receive one of the following TPC regimens determined prior to randomization:
Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR
Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles.
Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.
Intervention Type
Drug
Intervention Name(s)
Sacituzumab govitecan-hziy (SG)
Other Intervention Name(s)
GS-0132, IMMU-132, Trodelvy™
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda®
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Tablets administered orally
Primary Outcome Measure Information:
Title
Invasive Disease-free Survival (iDFS)
Description
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.
Time Frame
Up to 60 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization until death due to any cause.
Time Frame
Up to 96 months
Title
Distant Disease-free Survival (dDFS)
Description
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.
Time Frame
Up to 60 months
Title
Recurrence-free Survival (RFS)
Description
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.
Time Frame
Up to 60 months
Title
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame
First dose date up to 38 months plus 30 days
Title
Percentage of Participants Experiencing Laboratory Abnormalities
Time Frame
First dose date up to 38 months plus 30 days
Title
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
Description
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.
Time Frame
Up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
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 known 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Individual Site Status
Recruiting
Facility Name
Clearview Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Individual Site Status
Recruiting
Facility Name
Palo Verde Hematology Oncology
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85304
Country
United States
Individual Site Status
Recruiting
Facility Name
Compassionate Cancer Care Medical Group - Inc
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Los Angeles Cancer Network
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Name
Emad Ibrahim, MD, INC
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Individual Site Status
Recruiting
Facility Name
Midland Florida Clinical Research Center, L
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Health System
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Georgia Oncology Centers, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Edward Hospital
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Individual Site Status
Recruiting
Facility Name
Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Name
IU Health Arnett Hospital
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Healthcare, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Health
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Individual Site Status
Recruiting
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Name
Medstar Franklin Square Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Individual Site Status
Recruiting
Facility Name
American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
Regional Cancer Care Associates LLC
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Recruiting
Facility Name
Summit Medical Group, P.A.
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Health
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Individual Site Status
Recruiting
Facility Name
Laura and Isaac Perlmutter Cancer Canter
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Cancer and Blood Specialists
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Individual Site Status
Recruiting
Facility Name
Stony Brook Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Alliance
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States
Individual Site Status
Recruiting
Facility Name
Lancaster General Health
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Individual Site Status
Recruiting
Facility Name
Reading Hospital and Medical Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Name
Monument Health Cancer Care Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Medical Specialties, PLLC
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98373
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Oncology Associates
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-595-6184
Description
Gilead Clinical Trials Website
Learn more about this trial
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
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