OncoMatch/Clinical Trials/NCT05846789
SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers
Is NCT05846789 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including SOC Chemotherapy and Tocilizumab for metastatic breast cancer.
Treatment: SOC Chemotherapy · Tocilizumab — This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab in in Black and non-Black patients with metastatic triple negative or ER low breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 low expression (ER ≤ 9% weak staining) (≤ 9% weak staining)
ER-low (ER and PR ≤ 9% weak staining)
Required: PR (PGR) low expression (PR ≤ 9% weak staining) (≤ 9% weak staining)
ER-low (ER and PR ≤ 9% weak staining)
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ with FISH ratio > 2.0 or > 6 total HER2 gene copies per cell)
HER2 will be considered positive if scored 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of > 2.0 or > 6 total HER2 gene copies per cell
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: IL-6/IL-6R targeted agent (tocilizumab)
Prior treatment with or known contraindication to treatment with tocilizumab or other IL-6/IL-6R targeted agent
Cannot have received: PARP inhibitor (olaparib)
Planned treatment with Olaparib or other PARP inhibitor.
Lab requirements
Blood counts
ANC > 1.2 K/mm3; Platelets > 75 K/mm3; Hgb > 9.0 g/dL
Kidney function
Creatinine clearance > 50 mL/min using Cockcroft-Gault formula
Liver function
Total bilirubin < ULN (except Gilbert's disease: < 3.0 mg/dL); AST and ALT < 5.0 x ULN
Adequate organ function as indicated by: Total bilirubin < ULN (except in patients with documented Gilbert's disease, who must have a total bilirubin < 3.0 mg/dL); AST and ALT < 5.0 x ULN; Creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula; ANC > 1.2 K/mm3; Platelets > 75 K/ mm3; Hgb > 9.0 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University · Atlanta, Georgia
- IU Health Joe and Shelly Schwarz Cancer Center · Carmel, Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center · Indianapolis, Indiana
- Sidney and Lois Eskenazi Hospital · Indianapolis, Indiana
- Roswell Park Comprehensive Cancer Center · Buffalo, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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