OncoMatch/Clinical Trials/NCT04434040
Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
Is NCT04434040 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Atezolizumab and Sacituzumab govitecan for breast cancer.
Treatment: Atezolizumab · Sacituzumab govitecan — The purpose of this study is to determine if a combination of two drugs sacituzumab govitecan and atezolizumab works as a treatment for residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood. This research study involves the following investigational drugs: * Sacituzumab govitecan * Atezolizumab
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) wild-type (IHC 0 or 1+ OR ISH non-amplified (ratio HER2/CEP17 < 2.0 or copy number < 4 signals/cell))
HER2 negative in primary tumor pre-treatment by local pathology assessed according to current ASCO/CAP guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell), OR Immunohistochemistry (IHC) 0 or IHC 1+.
Required: ESR1 wild-type (< 10% of cells expressing hormonal receptors via IHC)
ER and PR negative in primary tumor pre-treatment defined as < 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
Required: PR (PGR) wild-type (< 10% of cells expressing hormonal receptors via IHC)
ER and PR negative in primary tumor pre-treatment defined as < 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
Patients must have received neoadjuvant chemotherapy prior to breast surgery.
Must have received: definitive breast surgery — adjuvant
Definitive breast surgery must have been performed and includes lumpectomy or mastectomy with pathologically clear margins (i.e. no ink on tumor). For patients undergoing lumpectomy, this must be followed by whole breast irradiation. Definitive surgery also includes axillary surgery, either sentinel lymph node biopsy or axillary lymph node dissection at the discretion of the attending surgeon.
Cannot have received: sacituzumab govitecan (sacituzumab govitecan)
Prior therapy with sacituzumab govitecan, irinotecan, or any topoisomerase I-containing antibody-drug conjugates at any time for early stage disease.
Cannot have received: irinotecan (irinotecan)
Prior therapy with sacituzumab govitecan, irinotecan, or any topoisomerase I-containing antibody-drug conjugates at any time for early stage disease.
Cannot have received: topoisomerase I-containing antibody-drug conjugate
Prior therapy with sacituzumab govitecan, irinotecan, or any topoisomerase I-containing antibody-drug conjugates at any time for early stage disease.
Cannot have received: adjuvant chemotherapy
Receipt of adjuvant chemotherapy (all chemotherapy prior to registration must have occurred in the preoperative setting)
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (1500/μL) without G-CSF support; WBC count ≥ 2.5 × 10^9/L (2500/μL); Absolute Lymphocyte count ≥ 0.5 × 10^9/L (500/μL); Platelet count ≥ 100 × 10^9/L (100,000/μL); Hemoglobin ≥ 90 g/L (9.0 g/dL), with or without transfusion
Kidney function
Serum creatinine < 1.5 x institutional ULN; Creatinine clearance ≥30 mL/min (Cockcroft-Gault)
Liver function
AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 × institutional ULN; Serum bilirubin ≤ 1.5 × institutional ULN (≤ 3 × ULN if Gilbert syndrome)
Adequate hematologic and organ function defined by the following: ANC ≥ 1.5 × 10^9/L (1500/μL) without granulocyte colony-stimulating factor support; WBC count ≥ 2.5 × 10^9/L (2500/μL); Absolute Lymphocyte count ≥ 0.5 × 10^9/L (500/μL); Platelet count ≥ 100 × 10^9/L (100,000/μL); Hemoglobin ≥ 90 g/L (9.0 g/dL), with or without transfusion; AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 × institutional upper limit of normal (ULN). Serum bilirubin ≤ 1.5 × institutional ULN with the following exception: Patients with known Gilbert syndrome: serum bilirubin level ≤ 3 × institutional ULN; Serum creatinine < 1.5 x institutional ULN; Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation; Serum albumin ≥ 25 g/L (2.5 g/dL); For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 × institutional ULN; For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Francisco · San Francisco, California
- University of Chicago Medical Center · Chicago, Illinois
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital · New Lenox, Illinois
- University of Chicago Medical Center for Advanced Care Orland Park · Orland Park, Illinois
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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