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Proteasome Inhibitor

Bortezomib + Pembrolizumab/Cisplatin for Metastatic Breast Cancer

Q: Are there any opportunities to join this medical investigation right now?

Indeed, the clinicaltrials.gov listing indicates that this study is actively enrolling patients. Initially posted on October 15th 2020, it has recently been updated as of October 7th 2021 and seeks to recruit 20 individuals across one site.

Q: What findings have emerged from experiments utilizing a combination of Bortezomib, pembrolizumab and cisplatin injections with bortezomib prior to the other two?

Currently, there are 1,688 active clinical trials exploring the efficacy of Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis. Specifically, 389 studies have reached Phase 3 development with most being hosted in Shanghai. Across 78356 locations worldwide, researchers are leveraging this new treatment to improve outcomes for patients everywhere.

Q: What conditions are the Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis treatment regimen commonly used to treat?

Bortezomib joined with pembrolizumab and cisplatin injections are often used to treat malignant neoplasms, but it's also frequently prescribed for unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, microsatellite instability high, and cases of heightened risk of recurrence.

Q: How many participants are being recruited into this trial?

Affirmative. Data hosted on clinicaltrials.gov displays that this medical experiment, which was posted initially on October 15th 2020, is in the process of recruiting participants. Approximately 20 volunteers are expected to be sourced from a single trial centre.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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

Secondary outcome measures

Calculate response

Other outcome measures

evaluate research biopsy for homologous recombination deficiency via Next Generation Sequencing

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bortezomib followed by pembro/cisExperimental Treatment1 Intervention

There is only one arm.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor

200 Previous Clinical Trials

203,206 Total Patients Enrolled

3 Trials studying Breast Cancer

230 Patients Enrolled for Breast Cancer

Joyce O'Shaughnessy, MDPrincipal InvestigatorTexas Oncology

7 Previous Clinical Trials

117 Total Patients Enrolled

1 Trials studying Breast Cancer

10 Patients Enrolled for Breast Cancer

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04265872 — Phase < 1

Breast Cancer Research Study Groups: Bortezomib followed by pembro/cis

Breast Cancer Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT04265872 — Phase < 1

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04265872 — Phase < 1

Frequently Asked Questions

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

Are there any opportunities to join this medical investigation right now?

"Indeed, the clinicaltrials.gov listing indicates that this study is actively enrolling patients. Initially posted on October 15th 2020, it has recently been updated as of October 7th 2021 and seeks to recruit 20 individuals across one site."

Answered by AI

What findings have emerged from experiments utilizing a combination of Bortezomib, pembrolizumab and cisplatin injections with bortezomib prior to the other two?

"Currently, there are 1,688 active clinical trials exploring the efficacy of Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis. Specifically, 389 studies have reached Phase 3 development with most being hosted in Shanghai. Across 78356 locations worldwide, researchers are leveraging this new treatment to improve outcomes for patients everywhere."

Answered by AI

What conditions are the Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis treatment regimen commonly used to treat?

"Bortezomib joined with pembrolizumab and cisplatin injections are often used to treat malignant neoplasms, but it's also frequently prescribed for unresectable melanoma, microsatellite instability high, and cases of heightened risk of recurrence."

Answered by AI

How many participants are being recruited into this trial?

"Affirmative. Data hosted on clinicaltrials.gov displays that this medical experiment, which was posted initially on October 15th 2020, is in the process of recruiting participants. Approximately 20 volunteers are expected to be sourced from a single trial centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC

2020. "Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04265872.

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