Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

Pfizer's innovative drug palbociclib (trade name: Ibrance®) got China National Drug Administration (CNDA) approval on July 31, 2018. Palbociclib combined with an aromatase inhibitor can be used to treat hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer or metastatic breast cancer. This brings more treatment options for hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer. How to scientifically evaluate the efficacy, tolerability, and safety of palbociclib combined with an aromatase inhibitor and to establish a more suitable treatment strategy for Chinese patients is one of the questions that need to be answered in clinical practice. This multi-center parallel-group randomized controlled trial will address on this issue.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shengjing Hospital
• Treatments: Aromatase Inhibitors; Letrozole; Palbociclib

Criteria

Inclusion Criteria:

• Patients with histological and imaging findings-confirmed hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer;

• postmenopausal patients;

• eligible patients receiving one or more treatment strategies who are followed up in the center where they receive treatment;

• provision of written informed consent.

Exclusion Criteria:

• Age < 18 years;

• pregnant woman;

• participating in other clinical trials.