Actively Recruiting
PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-09-23
30
Participants Needed
2
Research Sites
317 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
B
Breast Cancer Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of stage II to III triple negative breast cancer (ER and PR up to 10% allowed)
- Female aged 18 years or older
- ECOG performance status between 0 and 2
- Eligible for standard chemo-immunotherapy based on physician assessment
- Adequate bone marrow and organ function
- No uncontrolled autoimmune diseases or use of immunosuppressive medications
- Ability to understand and sign informed consent prior to study registration
You will not qualify if you...
- Inability to undergo PET or MRI scans
- Evidence of metastatic disease or loco-regional recurrence
- Diagnosis of inflammatory breast cancer
- Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Cesar A Santa-Maria, MD
CONTACT
H
Hopkins Breast Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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