NCT06245889RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 23 Jan 2024
- Start date
- 1 May 2024
- Primary completion date
- Jun 2029
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06245889
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 May 2024 to the primary completion date, Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors
Other illness
- Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence)
- Inflammatory breast cancer
Other
- Patients unable to undergo PET or MRI
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.