Trials Sponsors Conditions Drugs Pricing

Conditions

ER Positive, HER2 Negative Breast Cancer Estrogen-receptor-low Breast Cancer Metastatic Breast Cancer Triple Negative Breast Cancer

Keywords

Breast CancerPhase II

Outcome Measures

Primary Outcomes (3)

Overall response rate
through study completion (i.e. up to 2 years)
Efficacy of tocilizumab biosimilar in Black and non-Black patients
efficacy defined as using the difference in difference approach across race based cohorts
through study completion (i.e. up to 2 years)
Progression-free survival
through study completion (i.e. up to 2 years)

Secondary Outcomes (3)

Study Arms (4)

Black Monotherapy

ACTIVE COMPARATOR

Drug: SOC Chemotherapy

Black Combination treatment

EXPERIMENTAL

Drug: SOC ChemotherapyDrug: Tocilizumab/Tocilizumab Biosimilar

Non-Black Monotherapy

ACTIVE COMPARATOR

Drug: SOC Chemotherapy

Interventions

SOC ChemotherapyDrug

SOC Chemotherapy will be given AUC 6 IV q3 weeks for a maximum of 9 infusions.

Black Combination treatmentBlack MonotherapyNon-Black Combination treatmentNon-Black Monotherapy

Tocilizumab/Tocilizumab BiosimilarDrug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

≥ 18 years old at the time of informed consent
Ability to provide written informed consent and HIPAA authorization

Sponsors & Collaborators

Kathy Miller
Otherlead
Breast Cancer Research Foundation
Othercollaborator
Susan G. Komen Breast Cancer Foundation

Study Sites (7)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Carlos Aguilera, BACONTACT404-778-1868 winshipcto@emory.edu

Shipra Gandhi, MDPRINCIPAL INVESTIGATOR

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032, United States

RECRUITING

Xin Bryan, RNCONTACT317-274-5495

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Kathy Miller, MD
Indiana University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Bryan, RN

CONTACT

317-274-5495 zhongx@iupui.edu

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Ballvé-Lantero Professor of Medicine

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 6, 2023

Study Start

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (4)

Black Monotherapy

Black Combination treatment

Non-Black Monotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Non-Black Combination treatment

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (4)

Black Monotherapy

Black Combination treatment

Non-Black Monotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Non-Black Combination treatment

You may not qualify if:

Source record

Locations