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PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

NCT06245889 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-23

No results posted yet for this 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).

Conditions

Interventions

DRUG

Paclitaxel

chemotherapy

DRUG

Carboplatin

chemotherapy

DRUG

Pembrolizumab

immunotherapy

DRUG

Doxorubicin

additional chemotherapy - neoadjuvant or adjuvant rescue

DRUG

Cyclophosphamide

additional chemotherapy - adjuvant rescue

DRUG

Olaparib

adjuvant rescue

DRUG

Capecitabine

adjuvant rescue

Sponsors & Collaborators

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2029-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06245889 on ClinicalTrials.gov