Study on Pembrolizumab and Chemotherapy Before Surgery for Triple Negative Breast Cancer

Sponsor: University of Kansas Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03639948

Provider View

This clinical trial is exploring whether adding the immunotherapy drug Pembrolizumab to standard chemotherapy before surgery can improve outcomes for women with stage I, II, or III triple-negative breast cancer, which is known to be more aggressive and harder to treat.

Patient Parameters

Program Overview

The study aims to find out if using Pembrolizumab, an immunotherapy drug that helps the immune system fight cancer, along with chemotherapy before surgery, can improve treatment results for women with stage I, II, or III triple-negative breast cancer (TNBC). TNBC is a more aggressive type of breast cancer that is harder to treat and more likely to return, leading to poorer long-term survival rates compared to other breast cancer types. Researchers hope this new combination of treatments will lead to better outcomes for patients.

Eligibility Criteria

Inclusion Criteria

  • Understand the study and agree to sign a written consent form.
  • Have stage I, II, or III triple-negative breast cancer confirmed by lab tests.
  • Have not had surgery on the affected breast for the current cancer.
  • Have not received chemotherapy, hormone therapy, or radiation for this cancer.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have good organ and heart function.
  • Women must not be pregnant or breastfeeding and must either not be of childbearing potential or agree to use contraception if they are.

Exclusion Criteria

  • Currently using or planning to use other experimental treatments during the study.
  • Have already received chemotherapy, radiation, or surgery for breast cancer.
  • Have cancer that has spread to other parts of the body (metastatic disease).
  • Have inflammatory breast cancer.
  • Have had another cancer within the last 5 years, except for certain skin cancers or carcinoma in situ that have been treated.
  • Have allergies or reactions to similar drugs used in this study.
  • Have previously been treated with drugs targeting PD-1, PD-L1, or PD-L2, or similar immune therapies.
  • Have received a live vaccine within 30 days before starting the study treatment.
  • Are participating in another study or have used an investigational device within 4 weeks before starting the study treatment.
  • Have an immune deficiency or are on long-term steroid or immunosuppressive therapy within 7 days before starting Pembrolizumab.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have a history of lung inflammation (pneumonitis) needing steroids or have current pneumonitis.
  • Have an active infection needing treatment.
  • Have a known history of HIV.
  • Have a known history of Hepatitis B or active Hepatitis C infection.

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