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Proteasome Inhibitor

Bortezomib + Pembrolizumab/Cisplatin for Metastatic Breast Cancer

Phase < 1

Recruiting

Led By Joyce O'Shaughnessy, MD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

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

Must have

Adequate coagulation function

Have locoregional or pulmonary or hepatic metastatic disease that is amenable to core needle biopsy

Must not have

Known history of Hepatitis B or active Hepatitis C virus infection

Active autoimmune disease requiring systemic treatment in the past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing whether a drug called bortezomib can help treat a type of breast cancer that has spread to other parts of the body. The trial will look at the cancer cells before and after treatment to see how well the drug works.

Who is the study for?

This trial is for women over 18 with metastatic triple-negative breast cancer (TNBC) that's progressed after standard treatments. They must be in good physical condition, have normal blood, liver, and kidney functions, and not have had more than three prior chemo regimens for metastatic disease. Exclusions include severe health issues, active infections like hepatitis or tuberculosis, recent vaccines or radiotherapy, autoimmune diseases treated within two years, HIV infection or other cancers.

What is being tested?

The study tests if Bortezomib can make TNBC sensitive to Pembrolizumab and Cisplatin by inhibiting a DNA repair process called NHEJ. Patients' tumor genomes will be analyzed before and after Bortezomib treatment to see changes in HR-deficiency (a state where cells can't properly repair DNA) which could make the cancer more treatable.

What are the potential side effects?

Bortezomib may cause nerve damage leading to pain or numbness. Pembrolizumab might trigger immune-related side effects affecting organs like lungs causing pneumonitis or skin problems. Cisplatin can lead to kidney damage, hearing loss, nausea and vomiting.

Eligibility Criteria

Inclusion Criteria

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

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My blood clotting function is normal.

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My cancer has spread to my lungs or liver and can be biopsied with a needle.

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I am a woman aged 18 or older.

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I am fully active or can carry out light work.

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I have had brain metastasis but meet specific criteria.

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I have had 3 or fewer chemotherapy treatments for my advanced cancer.

Exclusion Criteria

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

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I have a history of Hepatitis B or currently have Hepatitis C.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I have not received a live vaccine in the last 30 days.

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I have a serious heart condition.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I am currently on medication for an infection.

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I have an immune system disorder or I'm on long-term steroids.

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I have an active case of tuberculosis.

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I have been diagnosed with HIV.

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I have another active cancer besides the one being treated.

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I have had lung inflammation treated with steroids or have it now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Calculate objective response rate (CR+PR) associated with bortezomib followed at disease progression with pembrolizumab and cisplatin in metastatic TNBC

Secondary study objectives

Calculate response

Other study objectives

evaluate research biopsy for homologous recombination deficiency via Next Generation Sequencing