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.
Primary:
To compare invasive disease-free survival (iDFS) between SG and pembrolizumab versus treatment of physician s choice (TPC).
Secondary:
- To compare OS between the 2 arms
- To compare distant disease-free survival (dDFS) as assessed by investigator between the 2 arms
- To compare safety and tolerability between them2 arms
- To compare time to worsening (TTW) quality of life (QoL) outcomes as measured by Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) between the 2 arms
Exploratory:
- To assess PD-L1 expression and its correlation to clinical outcomes
- To assess residual cancer burden (RCB) and its correlation to clinical outcomes
- To assess the presence of TILs and its correlation to clinical outcomes
- To assess tumor expression of Trop-2 as a potential predictive biomarker of response to SG plus pembrolizumab
- To explore blood and tumor biomarkers including ctDNA that may be associated with response to SG plus pembrolizumab
- To explore mechanisms underlying the development of resistance to SG plus pembrolizumab
- To explore the relationship of AEs to uridine diphosphate glucuronosyltransferase A1A (UGT1A1) status
- To characterize PK and immunogenicity of SG
- To compare additional QoL outcomes as measured by FACT-B, the 5-level version of the EuroQol 5-dimension (EQ-5D-5L), and the Patient-Reported
Sacitzumab govitecan/IMMU-132
Pembrolizumab (MK-3475)
Chemotherapy multiple agents systemic
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Monmouth Medical Center
- Monmouth Medical Center Vantage Point Center
- Rutgers Cancer Institute of New Jersey-University Hospital
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.