Recruiting

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

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…

ClinicalTrials.gov IDNCT06245889

PhasePHASE2

Enrollment30

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Age18 Years and older

SexFEMALE

I'm interested View official listing

Conditions studied

Triple Negative Breast Cancer

About this study

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

Primary outcomes

SULmax in relation to pCR (8 months)

Eligibility information

Inclusion Criteria: 1. Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible 2. Age ≥ 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 4. Eligible for standard chemo-immunotherapy as determined by treating physician, including consideration of: 1. Adequate marrow and organ function 2. Co-morbid conditions do not preclude the use of chemo-immunotherapy (such as uncontrolled autoimmune disease, or the use of immunosuppressive medications) 5. Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study Exclusion Criteria: 1. Patients unable to undergo PET or MRI 2. Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence) 3. Inflammatory breast cancer 4. Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors

Study locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21287 United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21287 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-01.