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NCT06245889 · ClinicalTrials.gov registry record · Phase 2
PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
A Phase 2 study of Triple Negative Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT06245889: Recruiting Phase 2 study of Triple Negative Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT06245889 is a Phase 2 study of Triple Negative Breast Cancer that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 30 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06245889, a Phase 2 study of Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Doxorubicin
- DRUG Paclitaxel
Study Locations (2)
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-05-01 |
| Est. Completion | 2030-06 |
| Phase | Phase 2 |
What NCT06245889 shows while recruiting
NCT06245889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06245889 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06245889 about?
NCT06245889 is a clinical study titled "PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC". 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 comple...
What is the current status of trial NCT06245889?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-05-01. Estimated completion is 2030-06.
What conditions does trial NCT06245889 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer.
What interventions are being tested in trial NCT06245889?
The interventions under investigation include: Pembrolizumab (DRUG), Cyclophosphamide (DRUG), Carboplatin (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT06245889?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06245889 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06245889's enrollment target sits among peer trials
30 93rd of 118 higher than 21 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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