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
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
II
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Johns Hopkins at Greenspring Station
10755 Falls Road Timonium, MD 21093
Sibley Memorial Hospital
5255 Loughboro Road, N.W., Washington, D.C., 20016
Keywords
Contact Us
(410) 955-8964Brief Summary
Eligible participants will undergo baseline procedures including research bloodwork, MRI and PET scan. Participants will then be treated with one cycle of paclitaxel, carboplatin and pembrolizumab. At the end of Cycle One (C1D15 +7days) patients will undergo repeat procedures (bloodwork, PET scan), and then continue with treatment for an additional three cycles. At the end of treatment patients will undergo repeat MRI. Patients achieving a cCR will be encouraged to proceed with surgery. Patients with clinical residual disease (RD) on MRI will be recommended a biopsy, if feasible and felt to be clinically ndicated, and proceed with “rescue” neoadjuvant doxorubicin and cyclophosphamide (AC) with pembrolizumab for four additional cycles, and then proceed with surgery. Tissue will be collected from the surgical product. Patients achieving a pCR may proceed with adjuvant pembrolizumab per standard of care, and treating physician discretion. Patients with pathological RD may proceed with “rescue” adjuvant AC with pembrolizumab for four additional cycles (if not received neoadjuvantly), per treating physician discretion. They may also receive adjuvant capecitabine or olaparib as indicated and per treating physician discretion.
Eligibility
Inclusion Criteria:
Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Eligible for standard chemo-immunotherapy as determined by treating physician, including consideration of:
- Adequate marrow and organ function
- Co-morbid conditions do not preclude the use of chemo-immunotherapy (such as uncontrolled autoimmune disease, or the use of immunosuppressive medications)
Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Exclusion Criteria:
- Patients unable to undergo PET or MRI
- Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence)
- Inflammatory breast cancer
- Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors