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Monoclonal Antibodies

Carboplatin + Atezolizumab for Stage IV Triple Negative Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

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

Must have

ER and PR negativity defined as =< 5% of cells expressing hormonal receptors via IHC analysis

Willing to undergo biopsy of a metastatic lesion

Must not have

GENERAL MEDICAL: Significant cardiovascular disease

GENERAL MEDICAL: Active tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is testing whether carboplatin works better with or without atezolizumab to treat patients with stage IV triple negative breast cancer.

Who is the study for?

This trial is for adults with stage IV triple negative breast cancer who have had zero or one prior chemo treatments and no previous carboplatin. They must have a certain level of blood cells, liver function, and kidney clearance. Participants need to be relatively healthy (ECOG 0-1), not pregnant, willing to use contraception if necessary, able to provide consent, and agree to a biopsy.

What is being tested?

The study compares the effectiveness of chemotherapy drug Carboplatin alone versus combined with Atezolizumab (a monoclonal antibody) in treating advanced breast cancer. It's randomized: patients are put into groups by chance. The goal is to see if adding Atezolizumab improves outcomes.

What are the potential side effects?

Carboplatin can cause nausea, fatigue, low blood counts leading to infection risk or bleeding problems. Atezolizumab may lead to immune-related side effects like inflammation in various organs, infusion reactions similar to allergic responses, and potential worsening of pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is not driven by estrogen or progesterone.

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I am willing to have a biopsy of my cancer that has spread.

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My alkaline phosphatase levels are within the limit, considering my liver metastases.

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My cancer is not driven by estrogen or progesterone.

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My white blood cell count is healthy without needing medication in the last 2 weeks.

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I am fully active or can carry out light work.

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My breast cancer is stage IV and lacks ER, PR, and HER2 receptors.

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I have had at most one chemotherapy treatment for my advanced cancer.

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I am considered postmenopausal based on my age and hormone levels.

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I have never been treated with carboplatin.

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My cancer is not HER2 positive according to the latest tests.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I have active tuberculosis.

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I have previously been treated with specific immune-targeting cancer drugs.

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I have untreated or worsening spinal cord compression due to cancer.

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My brain or spinal cord cancer does not meet certain criteria.

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I have not had major surgery in the last 4 weeks.

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I am allergic to certain medications made in Chinese hamster ovary cells or any part of atezolizumab.

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My cancer has spread to the lining of my brain and spinal cord.

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I have active hepatitis B or C.

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My cancer causes me severe pain that isn't managed well.

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I have high calcium levels in my blood that are causing symptoms.

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I have a history of lung scarring or currently have lung inflammation.

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I haven't taken steroids or immunosuppressants in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Clinical Benefit Rate (CBR)

Duration of Response (DOR)

Overall Response Rate (ORR)

+1 more

Other study objectives

Assignment of a Triple Negative Subtype in Tumor Tissue as Assessed by Ribonucleic Acid-sequencing (RNA-seq)

Changes in Gene Expression in Tumor Tissue as Assessed by Ribonucleic Acid-sequencing (RNA-seq)

Define Mutations Present in the Tumors as Assessed by Ribonucleic Acid-sequencing (RNA-seq)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 (atezolizumab, carboplatin)Experimental Treatment4 Interventions

Patients receive carboplatin as in Arm 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may cross-over to Arm 1 upon disease progression.

Group II: Arm 1 (atezolizumab, carboplatin)Experimental Treatment4 Interventions

Patients receive atezolizumab IV over 30-60 minutes and carboplatin IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

FDA approved

Carboplatin

FDA approved

0 / 25Eligibility criteria met