OncoMatch/Clinical Trials/NCT05846789
Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers
Is NCT05846789 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including SOC Chemotherapy and Tocilizumab/Tocilizumab Biosimilar for metastatic breast cancer.
Treatment: SOC Chemotherapy · Tocilizumab/Tocilizumab Biosimilar — This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab biosimilar in Black and non-Black patients with metastatic triple negative and ER-positive, HER2-negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) wild-type
Patients with HER2+ disease [excluded]. 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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: hormone therapy + CDK4/6 inhibitor — adjuvant or metastatic
Must have received prior hormone therapy + CDKi in the adjuvant or metastatic setting. There is no limit on the number of prior hormone therapy regimens.
Cannot have received: tocilizumab or other IL-6/IL-6R targeted agent
Prior treatment with or known contraindication to treatment with tocilizumab biosimilar 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 of > 50 mL/min using the Cockcroft-Gault formula
Liver function
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
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
- University of Kentucky-Lexington · Lexington, Kentucky
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05846789 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior tocilizumab or other IL-6/IL-6R targeted agent, PARP inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify