Examining the effects of an immunotherapy drug on chemotherapy for triple negative breast cancer
Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
This study is testing if adding an immunotherapy drug called pembrolizumab to standard chemotherapy helps improve the treatment effects for people with triple negative breast cancer who didn't fully respond to chemotherapy alone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | Pembrolizumab, chemotherapy, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05910710 on ClinicalTrials.gov |
What this trial studies
This study investigates the changes in the tumor microenvironment of patients with triple negative breast cancer who did not achieve a pathologic complete response after receiving neoadjuvant chemotherapy with or without the immuno-oncologic agent pembrolizumab. It involves analyzing samples from patients who have undergone treatment with a combination of weekly paclitaxel, carboplatin, and doxorubicin, with some receiving pembrolizumab and others not. The study utilizes advanced techniques such as Visium and whole genome/transcriptome sequencing to assess the impact of the treatment on the tumor microenvironment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with triple negative breast cancer who have received neoadjuvant chemotherapy and are scheduled for surgery.
Not a fit: Patients who have difficulty in obtaining sufficient samples or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how immunotherapy can enhance the effectiveness of chemotherapy in treating triple negative breast cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, particularly in the context of combining immunotherapy with chemotherapy for various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Triple negative breast cancer * Subjects administered neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab or not * Non pCR patients who are undergoing surgery after neoadjuvant chemotherapy * Sign to informed consent Exclusion Criteria: * Patients with difficulty in obtaining sufficient samples
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Yeon Hee Park, MD, Ph.D
- Email: yeonh.park@samsung.com
- Phone: 82-2-3410-1780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.