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.

NCT06245889

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~30 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:PaclitaxelCarboplatinPembrolizumabDoxorubicinCyclophosphamideOlaparib

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
SULmax in relation to pCR
Measured over 8 months
Triple Negative Breast Cancer

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.

  • Cesar A Santa-Maria, MD · STUDY_CHAIR · Johns Hopkins University

Opens a ready-to-send draft in your own email app — review before sending.

  • 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.