PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
Recruiting · NCT06245889 · Interventional (participants receive a specific treatment) · Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
2 locations listed across 1 US state.
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore, Maryland, United States
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore, Maryland, United States