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Recruiting NCT06245889

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Conditions: Triple Negative Breast Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 30
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Location: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland

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).

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06245889). StuddyBuddy aggregates publicly available trial information.