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PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
Eligible patients with stage 2 and 3 triple negative breast cancer will be treated with 4 cycles of neoadjuvant paclitaxel/carboplatin/pembrolizumab. A PET scan will be performed at baseline and after 1 cycle of therapy. A breast MRI will be performed after treatment completion. Patients with complete clinical response will proceed to surgery. Patients with clinical residual disease will complete neoadjuvant rescue with 4 cycles of doxorubicin/cyclophosphamide prior to surgery. If residual disease identified after surgery, adjuvant therapy to be determined by the treating oncologist (may include doxorubicin/cyclophosphamide/pembrolizumab, capecitabine etc).
Official title: A Pilot Study of Neoadjuvant Response-Adapted Chemotherapy With Pembrolizumab in Patients With Stage 2 and 3 Triple Negative Breast Cancer to Determine Early PET and Biomarker Dynamics
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-05-01
Completion Date
2030-06
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
Paclitaxel
chemotherapy
Carboplatin
chemotherapy
Pembrolizumab
immunotherapy
Doxorubicin
additional chemotherapy - neoadjuvant or adjuvant rescue
Cyclophosphamide
additional chemotherapy - adjuvant rescue
Olaparib
adjuvant rescue
Capecitabine
adjuvant rescue
Locations (2)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States