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Clinical Trial Summary

Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with neo-adjuvant chemotherapy. The sensitivity of breast cancer to chemotherapy is often determined by the underlying gene expression pattern and the molecular subtype of the tumor. The luminal subtype (A/B) which includes most of the ER+ tumors are less sensitive to chemotherapy with lower pathologic complete responses compared to ER- tumors. In addition, not all patients tolerate chemotherapy well. Due to these factors, pre-operative endocrine therapy emerged as an effective strategy to improve outcomes in patients with early stage hormone receptor positive breast cancer. Palbociclib, an oral CDK 4/6 inhibitor in combination with anastrazole was recently shown to achieve cell cycle arrest (defined as Ki-67 <2.7%) at cycle 1, day 15 in 85% of the studied population. This supports the evaluation of this combination further in the neo-adjuvant and adjuvant settings. Hence, we propose to conduct a study at the University of Nebraska Medical Center to assess the role of neo-adjuvant palbociclib (CDK 4/6 inhibitor) in combination with letrozole (aromatase inhibitor) +/-Goserelin (GnRH analogue) to improve overall response and surgical feasibility in post and pre-menopausal hormone receptor positive and Her-2 negative subjects with stage IIA-IIIC breast cancer.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05069038
Study type Interventional
Source University of Nebraska
Contact Shara Graalfs
Phone 402-596-3151
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date November 1, 2021
Completion date April 1, 2031

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