PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

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).

Conditions

Triple Negative Breast Cancer

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Study Overview

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Study Details

Study overview

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).

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

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Condition
Triple Negative Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Baltimore

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

Baltimore

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible
  • 2. Age ≥ 18 years
  • 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • 4. Eligible for standard chemo-immunotherapy as determined by treating physician, including consideration of:
  • 1. Adequate marrow and organ function
  • 2. Co-morbid conditions do not preclude the use of chemo-immunotherapy (such as uncontrolled autoimmune disease, or the use of immunosuppressive medications)
  • 5. Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
  • 1. Patients unable to undergo PET or MRI
  • 2. Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence)
  • 3. Inflammatory breast cancer
  • 4. Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,

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

Study Record Dates

2030-06