PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexFemale
• Healthy volunteersNo

You may be able to join 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 cannot join 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

pembrolizumab. A humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells. The ligands for PD-1 include programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs. Activated PD-1 negatively regulates T-cell activation and plays a key role in in tumor evasion from host immunity. NCI Drug Dictionary

Treatments listed in the registry

• Paclitaxel (Drug): chemotherapy
• Carboplatin (Drug): chemotherapy
• Pembrolizumab (Drug): immunotherapy
• Doxorubicin (Drug): additional chemotherapy - neoadjuvant or adjuvant rescue
• Cyclophosphamide (Drug): additional chemotherapy - adjuvant rescue
• Olaparib (Drug): adjuvant rescue
• Capecitabine (Drug): adjuvant rescue

Na · Sequential · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Part of the study plan
• MRI: Part of the study plan
• PET scans: Part of the study plan
• surgery: Part of the study plan

Main goals

• SULmax in relation to pCR (8 months)

Other goals

• Pathologic complete response (pCR)
• Circulating tumor deoxyribonucleic acid (ctDNA) clearance

Planned enrollment: 30 (estimated).

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland

Site status as of Oct 30, 2026. Check the live record before contacting a site.

These papers are listed in the registry record. Unless a paper is marked as about this trial, it is background research on the treatment or disease, not results from this study.

• Linked by the registry; not confirmed as results from this trialSchmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.
• Linked by the registry; not confirmed as results from this trialMittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020 Oct 10;396(10257):1090-1100. doi: 10.1016/S0140-6736(20)31953-X. Epub 2020 Sep 20.

• ClinicalTrials.gov NCT06245889
• NCI Drug Dictionary: C106432

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 2, 2026. Public record; not medical advice.