Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06245889
PHASE2

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

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

Interventions

DRUG

Paclitaxel

chemotherapy

DRUG

Carboplatin

chemotherapy

DRUG

Pembrolizumab

immunotherapy

DRUG

Doxorubicin

additional chemotherapy - neoadjuvant or adjuvant rescue

DRUG

Cyclophosphamide

additional chemotherapy - adjuvant rescue

DRUG

Olaparib

adjuvant rescue

DRUG

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