History of Changes for Study: NCT05633654

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)

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Study Record Versions

Version	Submitted Date	Changes
1	November 21, 2022	None (earliest Version on record)
2	December 21, 2022	Recruitment Status, Study Status, References, Contacts/Locations and Eligibility
3	January 12, 2023	Study Status and Contacts/Locations
4	January 26, 2023	Contacts/Locations and Study Status
5	February 14, 2023	Study Status and Contacts/Locations
6	April 20, 2023	Arms and Interventions, Study Status, Contacts/Locations, Eligibility and Outcome Measures
7	May 8, 2023	Study Status and Contacts/Locations
8	June 2, 2023	Study Status and Contacts/Locations
9	June 27, 2023	Contacts/Locations and Study Status
10	August 2, 2023	Study Status and Contacts/Locations
11	September 20, 2023	Contacts/Locations and Study Status
12	October 10, 2023	Study Status and Contacts/Locations
13	November 1, 2023	Contacts/Locations and Study Status
14	December 5, 2023	Study Status and Contacts/Locations
15	December 21, 2023	Contacts/Locations and Study Status
16	January 12, 2024	Study Status and Contacts/Locations
17	February 12, 2024	Contacts/Locations and Study Status
18	March 11, 2024	Study Status, Contacts/Locations and Arms and Interventions
19	April 30, 2024	Study Identification, Study Status, Contacts/Locations, Eligibility, Conditions and Sponsor/Collaborators

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	GS-US-595-6184
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 (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
Secondary IDs:

Study Status


Record Verification:	November 2022
Overall Status:	Not yet recruiting
Study Start:	March 2023
Primary Completion:	July 2027 [Anticipated]
Study Completion:	January 2031 [Anticipated]

First Submitted:	November 21, 2022
First Submitted that Met QC Criteria:	November 21, 2022
First Posted:	December 1, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	November 21, 2022
Last Update Posted:	December 1, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Gilead Sciences
Responsible Party:	Sponsor
Collaborators:	Alliance Foundation Trials, LLC.

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.

Detailed Description:

Conditions


Conditions:	Triple Negative Breast Cancer
Keywords:	OptimICE-RD AFT-65

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	1514 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Sacituzumab govitecan-hziy (SG) + Pembrolizumab

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.

Biological: Sacituzumab govitecan-hziy (SG)

Administered intravenously

Other Names:

GS-0132
IMMU-132
Trodelvy™

Biological: Pembrolizumab

Administered intravenously

Other Names:

Keytruda®

Active Comparator: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine

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.

Biological: Pembrolizumab

Administered intravenously

Other Names:

Keytruda®

Drug: Capecitabine

Tablets administered orally

Other Names:

Xeloda

Outcome Measures


Primary Outcome Measures:
1.	Invasive Disease-free Survival (iDFS) [ Time Frame: 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.
Secondary Outcome Measures:
1.	Overall Survival (OS) [ Time Frame: 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) [ Time Frame: 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.	Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 38 months plus 30 days ]
4.	Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: First dose date up to 38 months plus 30 days ]
5.	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 [ Time Frame: 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.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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 (IHC and/or 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), X-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.

Contacts/Locations


Central Contact Person:	Gilead Clinical Study Information Center Telephone: 1-833-445-3230 (GILEAD-0) Email: GileadClinicalTrials@gilead.com
Study Officials:	Gilead Study Director Study Director Gilead Sciences
Locations:

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: