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PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Study acronym: NeoADAPT
StatusRecruiting
PhasePhase 2
Started2024-05-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
minor
2 amendments v6-v7
2 re-verifications since 2025-09-18, no change to tracked fields
2024-09-06
minor
Study Status, Sponsor/Collaborators v5
Collaborators+33 characters
Breast Cancer Research Foundation
2024-05-06
minor
Study Status v4
Start dateestimated 2024-04→confirmed 2024-05-01
2024-04-08
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sites1→2
2024-03-22
minor
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2024-03-19
minor
Study Status v1
Start date2024-02→2024-04
2024-02-05
minor
Original filing
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).
Trial Details
NCT Number NCT06245889
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Breast Cancer Research Foundation
Conditions Triple Negative Breast Cancer
Enrollment 30 participants
Start Date 2024-05-01
Primary Completion 2029-06 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-03