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Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer

Breast Cancer Clinical Trial

Official title:
Pilot Trial of Anastrozole and Palbociclib as First-Line Therapy and as Maintenance Therapy After First Line Chemotherapy in Hormone Receptor Positive, HER2-Negative Postmenopausal Metastatic Breast Cancer

Clinical Trial Summary

This is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal patients with HR-positive, HER2-negative metastatic breast cancer. Pre- and perimenopausal women must receive therapy with an LHRH agonist. The LHRH agonist will be by choice for an approved LHRH agonist administered according to its respective prescribing information. Following informed consent and eligibility check, subjects will be enrolled to either Cohort A or Cohort B.

Clinical Trial Description

A total of 40 subjects will be enrolled over an enrollment period of 18-24 months. The study is planned to enroll up to 25 patients in Cohort A (upfront) and 15 patients in Cohort B (maintenance). Subjects will be recruited through Levine Cancer Institute locations and through referrals. Women of any race or ethnic origin who meet the study criteria may participate in this clinical trial. Males will not be eligible for this study. Breast cancer in men is rare and the efficacy of aromatase inhibitors in males is limited. Children are not included in this clinical trial because the effects of palbociclib are not known in the pediatric population, but may be eligible for other pediatric trials. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02942355
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 7, 2016
Completion date June 30, 2026
View Details
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