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

Overview

About this study

The purose 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.

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.

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.

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

Eligibility last updated 6/27/23. 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.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Lida Mina, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Pooja Advani, M.B.B.S., M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available