At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Triple-negative breast cancer (ER/PR ≤10%, HER2-negative) with initial clinical stage T1cN1-2 or T2-4N0-2 (Stage II-III)
- ✓No residual invasive disease after neoadjuvant therapy (DCIS allowed)
- ✓Received neoadjuvant chemotherapy with pembrolizumab for minimum 6 cycles, all completed preoperatively
- ✕Stage IV (metastatic) breast cancer
- ✕Prior invasive breast cancer (ipsilateral or contralateral); prior DCIS allowed
- ✕Evidence of recurrent disease after preoperative therapy and surgery
- ✕Known active liver disease (HBV, HCV, autoimmune hepatitis, sclerosing cholangitis)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Patient Observation, and 4 other interventions for Anatomic Stage II Breast Cancer AJCC v8 and 3 related conditions. Currently recruiting, targeting 1,295 participants across 838 sites in 3 countries.
Signals
Detailed Summary
This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks after surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation is as good as receiving pembrolizumab for 27 weeks after surgery in triple-negative breast cancer patients who achieved a pathologic complete response after preoperative treatment with chemotherapy and pembrolizumab.
Study Details
Timeline
Arms & Interventions
Patients receive pembrolizumab IV over 25-40 minutes Q3W or Q6W for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or MRI and during follow-up.
Patients undergo observation for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or MRI during follow-up.
Interventions
Given IV
Undergo observation
Undergo biopsy
Undergo collection of blood
Ancillary studies
Ancillary studies