Study on PET Scan Guided Treatment for Stage 2 and 3 Triple Negative Breast Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06245889

Provider View

This clinical trial is exploring a treatment plan for patients with stage 2 and 3 triple negative breast cancer, using PET scans to guide therapy decisions. The study involves chemotherapy, immunotherapy, and surgery, with adjustments based on how well the cancer responds to initial treatments.

Patient Parameters

Program Overview

The study aims to determine if using PET scans to guide treatment decisions can improve outcomes for patients with stage 2 and 3 triple negative breast cancer. Participants will receive a combination of chemotherapy and immunotherapy before surgery. PET scans will be used to assess the cancer's response after the first cycle of treatment. Depending on the results, patients may continue with the initial treatment plan or switch to a different chemotherapy regimen before surgery. After surgery, further treatment will be decided based on any remaining cancer.

Description

Participants in this study will start with initial tests, including bloodwork, MRI, and a PET scan. They will then receive one cycle of a treatment combination that includes paclitaxel, carboplatin, and pembrolizumab. After the first cycle, they will have another PET scan and bloodwork to check the cancer's response. If the cancer is responding well, they will continue with three more cycles of the same treatment.

If the MRI shows that the cancer has completely responded, patients will proceed to surgery. If there is still some cancer present, a biopsy may be recommended, and patients might receive additional chemotherapy with doxorubicin and cyclophosphamide, along with pembrolizumab, before surgery.

After surgery, if no cancer is found, patients may continue with pembrolizumab as part of their standard care. If cancer remains, additional chemotherapy or other treatments like capecitabine or olaparib may be considered, based on the doctor's recommendation.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage 2 or 3 triple negative breast cancer, with estrogen and progesterone receptors up to 10%.
  • Aged 18 years or older.
  • In good general health, with an ECOG performance status of 0 to 2.
  • Eligible for standard chemotherapy and immunotherapy, as determined by the doctor.
  • Must have adequate blood and organ function.
  • Must not have conditions that prevent the use of chemotherapy and immunotherapy.
  • Must be able to understand and willing to sign a consent form to participate in the study.

Exclusion Criteria

  • Unable to undergo PET or MRI scans.
  • Evidence of cancer spread to other parts of the body or recurrence in the chest wall.
  • Diagnosed with inflammatory breast cancer.
  • Previously treated with paclitaxel, carboplatin, or immune checkpoint inhibitors.

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