Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer
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.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2021-09-30
- Completion
- 2022-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palbociclib | Small molecule | 125 mg | Oral |
| Comparator | Letrozole | Other / unclassified | 2.5 mg | Oral |