PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
Recruiting now · Phase 2
Conditions studied: Triple Negative Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT06245889
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 30
- Starts
- 2024-05-01
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2025-09-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Eligible for standard chemo-immunotherapy as determined by treating physician, including consideration of:
- Adequate marrow and organ function
- Co-morbid conditions do not preclude the use of chemo-immunotherapy (such as uncontrolled autoimmune disease, or the use of immunosuppressive medications)
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
You may not qualify if…
- Patients unable to undergo PET or MRI
- Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence)
- Inflammatory breast cancer
- Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors
Where it is running
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (enrolling)
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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