A phase II clinical trial assessing the safety of neoadjuvant palbociclib in combination with endocrine therapy for post and pre-menopausal patients with early stage hormone receptor positive and Her-2/neu negative breast cancer
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Krishnamurthy, Jairam
Contact Information:
Shara Graalfs
+1 402-596-3151
shara.graalfs@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05069038?term=NCT05069038&rank=1
Summary
1.1 Primary Objective
1. To determine the overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy in patients with hormone receptor positive and Her-2/neu negative breast cancer
2. To determine the clinical benefit rate (CR+PR+SD) with neoadjuvant palbociclib in combination with endocrine therapy in patients with hormone receptor positive and Her-2/neu negative breast cancer
3. To determine the improvement in surgical feasibility with neoadjuvant palbociclib in combination with endocrine therapy in patients with hormone receptor positive and Her-2/neu negative breast cancer
1.2 Secondary Objectives
1. To determine the tumor down staging rate with neoadjuvant palbociclib in combination with endocrine therapy in patients with hormone receptor positive and Her-2/neu negative breast cancer
2. To determine the axillary down staging rate with neoadjuvant palbociclib in combination with endocrine therapy in patients with hormone receptor positive and Her-2/neu negative breast cancer
3. To determine the progression free survival therapy in patients with hormone receptor positive and Her-2/neu negative breast cancer who received neoadjuvant palbociclib in combination with endocrine therapy.
4. To assess the changes in genetic signature in the Mammaprint/Discoverprint after neoadjuvant treatment with palbociclib in combination with endocrine therapy