PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
This study is looking at how well a treatment plan works for people with Stage II-III triple-negative breast cancer (TNBC). You would receive chemotherapy drugs called paclitaxel and carboplatin, along with an immunotherapy drug called pembrolizumab. Doctors will use PET scans to see how your tumor responds after the first treatment cycle. If the initial treatment doesn't completely shrink the tumor, you might receive additional chemotherapy with doxorubicin and cyclophosphamide before surgery. The main goal is to see if changes in your PET scan can predict how well the treatment shrinks the tumor (pathologic complete response, or pCR). This study is for women aged 18 or older with TNBC and good overall health. About 30 people are expected to join.
- Study design
- This is an interventional study, meaning participants receive specific treatments. It plans to enroll 30 participants.
- What's involved
- You would undergo baseline bloodwork, MRI, and PET scans, then receive one cycle of paclitaxel, carboplatin, and pembrolizumab. After this, you'd have repeat bloodwork and a PET scan, and continue treatment for three more cycles, with ctDNA collected at the start of each cycle. An MRI will be performed at the end of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, SULmax in relation to pCR, is measured at 8 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
At a glance
Conditions
NCT06245889
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Marylandstudy coordinator listed
Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Cesar A Santa-Maria, MD · STUDY_CHAIR · Johns Hopkins University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- SULmax in relation to pCR8 months
Evaluate if lack of decrease in fluorodeooxyglucose (FDG) / positron emission tomography (PET) standardized uptake value corrected for lean body mass (SULmax) by \<40% after 1 cycle of neoadjuvant therapy correlates with residual disease at the time of surgery.