Trial 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/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
- Phase
- Phase 3
- Sponsor
- Gilead Sciences
- Conditions
- Triple Negative Breast Cancer
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
* Individuals must have received appropriate radiotherapy aligned with local/institutional practice 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 malignancy
* 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%Cardiac
* Active serious infections requiring anti-microbial therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Restrictions found (3)
- CardiacOutrightexclusion
MI within 6 months; LVEF < 50%
Show in the text - Performance statusOutrightinclusion
ECOG 0-1
Show in the text - Prior malignancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Tufts Medical Center · Boston, Suffolk County
- Massachusetts General Hospital · Boston, Suffolk County
- Beth Israel Deaconess Medical Center · Boston, Suffolk County
- Dana Farber Cancer Institute · Boston, Suffolk County
- Dana-Farber Cancer Institute @Foxborough · Foxborough, Norfolk County
- Dana-Farber Cancer Institude at Merrimack Valley · Methuen, Essex County
- Dana Farber Cancer Institute @ Milford Regional Hospital · Milford, Worcester County
- Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital · South Weymouth, Norfolk County