Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy
Status:
Not yet recruiting
Trial end date:
2031-04-01
Target enrollment:
Participant gender:
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.