RECRUITING

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-05-01
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06245889

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible
  2. 2. Age ≥ 18 years
  3. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  4. 4. Eligible for standard chemo-immunotherapy as determined by treating physician, including consideration of:
  5. 1. Adequate marrow and organ function
  6. 2. Co-morbid conditions do not preclude the use of chemo-immunotherapy (such as uncontrolled autoimmune disease, or the use of immunosuppressive medications)
  7. 5. Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
  1. 1. Patients unable to undergo PET or MRI
  2. 2. Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence)
  3. 3. Inflammatory breast cancer
  4. 4. Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors

Contacts and Locations

Study Contact

Cesar A Santa-Maria, MD
CONTACT
410-614-0874
csantam2@jhmi.edu
Hopkins Breast Trials
CONTACT
410-614-1361
HopkinsBreastTrials@jhmi.edu

Principal Investigator

Cesar A Santa-Maria, MD
STUDY_CHAIR
Johns Hopkins University

Study Locations (Sites)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2030-06

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • triple negative
  • neoadjuvant

Additional Relevant MeSH Terms

  • Triple Negative Breast Cancer