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Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers

Name: Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers — clinical trial record (NCT05846789)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 2

SponsorKathy Miller

Started2024-07-02

View on ClinicalTrials.gov ↗

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.

Amendment history 4 changes detected by DataLookout

2026-09-04

Primary endpoint(s) modified

WasEfficacy of tocilizumab in Black and non-Black patients, Overall response rate, Progression-free survival

NowEfficacy of tocilizumab biosimilar in Black and non-Black patients, Overall response rate, Progression-free survival

2026-09-04

Primary completion pushed: 2026-12 → 2027-12

2026-09-04

Completion pushed: 2026-12 → 2027-12

2026-09-04

Interventions modified

Trial Details

NCT Number	NCT05846789
Lead Sponsor	Kathy Miller Collaborators: Genentech, Inc., Breast Cancer Research Foundation, Susan G. Komen Breast Cancer Foundation
Conditions	Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-low Breast Cancer, ER Positive, HER2 Negative Breast Cancer
Enrollment	168 participants
Start Date	2024-07-02
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-09-03