← Back to Search

Alkylating agents

Carboplatin +/- Tocilizumab for Breast Cancer

Phase 2

Recruiting

Led By Kathy Miller, MD

Research Sponsored by Kathy Miller

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years old at the time of informed consent

Disease amenable to and consent for study-specific biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (i.e. up to 2 years)

Awards & highlights

Study Summary

This trial compares two treatments for advanced breast cancer, one on its own and one combined with a drug to see which works best.

Who is the study for?

This trial is for adults with metastatic triple negative or ER-low breast cancer who have completed prior therapy at least a year ago. They must be in good physical condition, have adequate organ function, and not be pregnant. Participants need to consent to biopsies and agree to use effective contraception. Those with treated brain metastases may join if stable.Check my eligibility

What is being tested?

The study compares carboplatin alone versus carboplatin combined with tocilizumab in patients with certain types of advanced breast cancer. It's randomized, meaning participants are assigned to one of the two treatment groups by chance.See study design

What are the potential side effects?

Potential side effects include allergic reactions, liver enzyme elevation, blood cell count changes (which can increase infection risk), fatigue, and possible infusion-related reactions from Tocilizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I agree to a biopsy for this study.

Select...

I have not had chemotherapy for cancer that has spread.

Select...

My breast cancer has returned, cannot be cured with surgery or radiation, and lacks certain hormone receptors.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (i.e. up to 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (i.e. up to 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (i.e. up to 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of tocilizumab in Black and non-Black patients

Overall response rate

Progression-free survival

Secondary outcome measures

Evaluate the differences in inflammatory pathways between Black and non-Black patients

Evaluate the impact of Duffy genotype on efficacy in Black patients

Safety of carboplatin monotherapy compared to carboplatin combined with tocilizumab using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Non-Black Combination treatmentExperimental Treatment2 Interventions

Group II: Black Combination treatmentExperimental Treatment2 Interventions

Group III: Black MonotherapyActive Control1 Intervention

Group IV: Non-Black MonotherapyActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Tocilizumab

2012

Completed Phase 4

~1840

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kathy MillerLead Sponsor

7 Previous Clinical Trials

134 Total Patients Enrolled

1 Trials studying Breast Cancer

42 Patients Enrolled for Breast Cancer

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

567,975 Total Patients Enrolled

97 Trials studying Breast Cancer

23,218 Patients Enrolled for Breast Cancer

Kathy Miller, MDPrincipal InvestigatorIndiana University

16 Previous Clinical Trials

1,186 Total Patients Enrolled

6 Trials studying Breast Cancer

886 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05846789 — Phase 2

Breast Cancer Research Study Groups: Black Monotherapy, Black Combination treatment, Non-Black Combination treatment, Non-Black Monotherapy

Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05846789 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05846789 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Black Combination therapy been given the go-ahead by the FDA?

"Although no efficacy data exists yet, the safety of the Black Combination treatment was rated a 2 on our team's scale due to prior Phase 2 trial findings."

Answered by AI

Is recruitment still active for this research trial?

"According to information on clinicaltrials.gov, this trial has ceased recruitment since its last edit on April 27th 2023. Nonetheless, there are still 2412 other trials actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial of Carboplatin +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers

Kathy Miller 2024. "Phase II Trial of Carboplatin +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05846789.