Study on Pembrolizumab, IRX-2, and Chemotherapy for Triple Negative Breast Cancer
Sponsor: Providence Health & Services
ClinicalTrials ID:NCT04373031
This clinical trial is testing a combination of pembrolizumab, IRX-2, and chemotherapy to see if it can effectively treat triple negative breast cancer (TNBC) before surgery. The study aims to evaluate the safety and effectiveness of these treatments when used together.
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Program Overview
This study is exploring whether a combination of pembrolizumab, a type of immunotherapy, and chemotherapy can help treat triple negative breast cancer (TNBC) before surgery. The trial will compare different treatment combinations to see which works best. Participants will receive either pembrolizumab with chemotherapy or pembrolizumab with IRX-2 and chemotherapy. The goal is to find out if these combinations can shrink tumors and improve outcomes for patients with TNBC.
Description
This clinical trial is designed to test the effectiveness of combining pembrolizumab, an immunotherapy drug, with chemotherapy for treating triple negative breast cancer (TNBC) before surgery. The study will compare different treatment combinations to see which is most effective.
Participants will be randomly assigned to one of the following treatment groups:
- Control Group: Receive pembrolizumab and chemotherapy (paclitaxel followed by doxorubicin and cyclophosphamide) before surgery.
- Group A: Receive pembrolizumab, IRX-2, and chemotherapy (paclitaxel followed by doxorubicin and cyclophosphamide) before surgery.
The study will monitor the safety and effectiveness of these treatments in shrinking tumors and improving patient outcomes. Participants will undergo regular health checks and assessments to track their progress throughout the trial.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older and able to provide informed consent.
- Have a confirmed diagnosis of triple negative breast cancer (TNBC) that has not spread to other parts of the body.
- Have not received prior treatment for TNBC.
- Have a tumor that meets specific size and location criteria.
- Provide a tumor sample for research purposes.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ function and a heart function of at least 50%.
- Agree to use effective contraception during the study and for a specified period after the last dose of treatment.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
Exclusion Criteria
- Have had another invasive cancer within the past 5 years, except for certain skin or cervical cancers.
- Have received chemotherapy, targeted therapy, or radiation therapy in the past 12 months.
- Have previously been treated with certain immunotherapy drugs or participated in related clinical trials.
- Are currently participating in another clinical trial or have recently received an investigational treatment.
- Have received a live vaccine within 30 days before starting the study treatment.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have a diagnosis of immunodeficiency or are receiving immunosuppressive therapy.
- Have active infections like HIV, Hepatitis B, or Hepatitis C.
- Have a history of lung inflammation or current lung issues.
- Have significant heart disease or recent heart events.
- Have any condition or situation that might pose a risk or interfere with the study.
- Are pregnant or breastfeeding, or planning to become pregnant during the study.
- Have allergies to the study drugs or their components.
- Have a history of active tuberculosis.
- Are allergic to ciprofloxacin or similar antibiotics.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Portland Medical Center | 97213 | Portland | Oregon |
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