Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Progesterone Receptor Negative
- Breast Adenocarcinoma
- Estrogen Receptor Negative Breast Cancer
- Estrogen Receptor Positive Breast Cancer
- HER2/Neu Negative
- Invasive Breast Carcinoma
- Progesterone Receptor Positive Tumor
- Stage IIIB Breast Cancer
- Stage II Breast Cancer
- Stage IIA Breast Cancer
- Triple-Negative Breast Carcinoma
- Stage IIB Breast Cancer
- Stage IIIA Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Both cohorts will receive the identical doses and treatment schedules of decitabine and pembrolizumab followed by a standard neoadjuvant chemotherapy regimen. Both cohorts will receive 4 cycles of dose-dense AC followed by 12 doses of weekly paclitaxel. Paclitaxel will be combined with carboplatin f...
Both cohorts will receive the identical doses and treatment schedules of decitabine and pembrolizumab followed by a standard neoadjuvant chemotherapy regimen. Both cohorts will receive 4 cycles of dose-dense AC followed by 12 doses of weekly paclitaxel. Paclitaxel will be combined with carboplatin for Cohort A (TNBC). The primary safety objective will be to evaluate the safety and toxicity of sequential decitabine plus pembrolizumab followed by dose-dense AC, weekly paclitaxel (or paclitaxel plus carboplatin) administered as neoadjuvant therapy. If the breast tumor is resectable following completion of all protocol therapy, breast-conserving surgery or mastectomy and axillary surgical staging (either sentinel node biopsy and/or axillary dissection) will be performed.
Tracking Information
- NCT #
- NCT02957968
- Collaborators
- Merck Sharp & Dohme Corp.
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Harry D. Bear, M.D., Ph.D. Massey Cancer Center
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