Using PET scans to guide treatment for triple negative breast cancer
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
This study tests if using PET scans can help doctors tailor treatment for people with stage 2 and 3 triple negative breast cancer to improve their chances of a successful surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | immunotherapy, pembrolizumab, cyclophosphamide, doxorubicin |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT06245889 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with stage 2 and 3 triple negative breast cancer (TNBC) who will receive a combination of paclitaxel, carboplatin, and pembrolizumab as neoadjuvant therapy. Participants will undergo PET scans and MRIs at various stages to assess their response to treatment. Those achieving a complete clinical response will proceed to surgery, while those with residual disease will receive additional neoadjuvant therapy before surgery. The study aims to optimize treatment based on individual responses to therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage II-III triple negative breast cancer.
Not a fit: Patients with metastatic disease, inflammatory breast cancer, or those who have previously received certain treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with triple negative breast cancer.
How similar studies have performed: Other studies have shown promise in using imaging to adapt treatment strategies, making this approach both innovative and supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland and 1 other locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Cesar A Santa-Maria, MD
- Email: csantam2@jhmi.edu
- Phone: 410-614-0874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.