Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-04)

Overview

About this study

The purpose of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Individuals with locally advanced, inoperable, or metastatic triple-negative breast
cancer (TNBC) who have not received previous systemic therapy for advanced disease and
whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.

- Individuals must have completed treatment for Stage I to 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 for this study.

- TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed
centrally on a recent or archival tumor specimen.

- Individuals must have measurable disease by computed tomography (CT) or magnetic
resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors
(RECIST) Version 1.1 criteria as evaluated locally.

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

- Demonstrates adequate organ function.

- Male and female individuals of childbearing potential who engage in heterosexual
intercourse must agree to use protocol-specified method(s) of contraception.

- Individuals with HIV must be on antiretroviral therapy (ART) and have a
well-controlled HIV infection/disease.

Exclusion Criteria:

- Positive serum pregnancy test or women who are lactating.

- Received prior therapy with an agent directed to another stimulatory or coinhibitory
T-cell receptor.

- Individuals may not have received systemic anticancer treatment within the previous 6
months or radiation therapy within 2 weeks prior to enrollment.

- Individuals 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.

- Have previously received topoisomerase 1 inhibitors or antibody drug conjugates
containing a topoisomerase inhibitor.

- Have an active second malignancy.

- Have active serious infection requiring antibiotics.

- Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or
Multicentric Castleman Disease.

- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

- Has an active autoimmune disease that has required systemic treatment in the past 2
years.

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

Eligibility last updated 6/10/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Roberto Leon-Ferre, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions