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)

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05633654

Enrollment

1514

Registered

2022-12-01

Start date

2022-12-12

Completion date

2031-08-01

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple Negative Breast Cancer

Keywords

AFT-65, GBG 119, NSABP B-63, OptimICE-RD

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.

Interventions

DRUGSacituzumab govitecan-hziy (SG)

Administered intravenously

DRUGPembrolizumab

Administered intravenously

DRUGCapecitabine

Tablets administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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, 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/

Design outcomes

Primary

Measure	Time frame	Description
Invasive Disease-free Survival (iDFS)	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

Measure	Time frame	Description
Overall Survival (OS)	Up to 96 months	OS is defined as the time from the date of randomization until death due to any cause.
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	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.
Recurrence-free Survival (RFS)	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.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	First dose date up to 38 months plus 30 days	—
Percentage of Participants Experiencing Laboratory Abnormalities	First dose date up to 38 months plus 30 days	—
Distant Disease-free Survival (dDFS)	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.

Countries

Australia, France, Germany, Ireland, South Korea, Spain, United Kingdom, United States

Contacts

CONTACTGilead Clinical Study Information Center

GileadClinicalTrials@gilead.com1-833-445-3230 (GILEAD-0)

STUDY_DIRECTORGilead Study Director

Gilead Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026