Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Chemo-Immunotherapy with Pembrolizumab Before Surgery
18 Years and older, Female
WINSHIP5818-22 (primary)
NCI-2023-02943
STUDY00005452
Summary
This study evaluates immune and clinical responses in patients with early stage triple negative breast cancer undergoing combination chemotherapy and immunotherapy. Using blood and tissue samples may explain what changes occur in the immune system and the breast cancer when a patient receives standard of care chemotherapy and immunotherapy prior to surgery and how these changes are associated with response (how much cancer is still present) at the time of surgery.
Objectives
PRIMARY OBJECTIVE:
I. To determine whether standard of care neoadjuvant chemo-immunotherapy leads to the induction of a pro-inflammatory cytokine milieu in the blood, which is induced with 24 hours of treatment initiation, persists through the course of the therapy and is associated with pathologic complete response in the tissue.
OUTLINE: This is an observational study.
Patients undergo collection of blood and tissue samples on study. Patients also have their medical records reviewed on study.
Eligibility
- Female subjects, age >= 18 years
- Newly diagnosed, previously untreated, non-metastatic stage II-III invasive breast cancer
- Estrogen receptor immunohistochemistry (IHC) expression =< 10%; progesterone receptor IHC expression =< 10%; HER2 negative
* HER2 negativity is defined as either of the following by local laboratory assessment:
** IHC 0, 1+, or 2+ and In situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell)
- Willingness and ability of the subject to comply with scheduled visits, standard of care drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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