PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC," is studying a new treatment approach for women with stage 2 and 3 triple negative breast cancer (TNBC). Participants will receive a combination of three medications—paclitaxel, carboplatin, and pembrolizumab—over four cycles before their surgery. To monitor how well the treatment is working, patients will undergo a PET scan before starting therapy and after the first cycle, with an additional breast MRI after completing the treatment. Depending on their response, patients either proceed to surgery or receive additional treatment before surgery.

To be eligible for this trial, women must be at least 18 years old and have a specific type of breast cancer (TNBC) that is not too advanced. They should also be healthy enough to receive standard chemotherapy and immunotherapy. This means having good organ function and no serious health issues that could interfere with treatment. The trial is currently recruiting participants, and it’s important for potential participants to understand the treatment process and the tests involved. This study aims to find out how best to customize treatment based on how the cancer responds, which could lead to better outcomes for patients.

Gender

FEMALE

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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