Home › Triple-Negative Breast Cancer › NCT06245889

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

A Pilot Study of Neoadjuvant Response-Adapted Chemotherapy With Pembrolizumab in Patients With Stage 2 and 3 Triple Negative Breast Cancer to Determine Early PET and Biomarker Dynamics

Who can join

Ages 18 and older · Women

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

About the study

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).

What is being tested

• Paclitaxel (drug)
• Carboplatin (drug)
• Pembrolizumab (drug)
• Doxorubicin (drug)
• Cyclophosphamide (drug)
• Olaparib (drug)

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Participants: 30 · Started: May 1, 2024

Contact the study team

• Cesar A Santa-Maria, MD · Phone: 410-614-0874
• Hopkins Breast Trials · Phone: 410-614-1361

Official record on ClinicalTrials.gov — NCT06245889

Locations in the U.S.

Conditions

• Triple-Negative Breast Cancer
• Breast Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.