Safety and Pharmacokinetics of Vepdegestrant in Japanese Patients with Advanced Breast Cancer
Author Information
Author(s): Iwata Hiroji, Naito Yoichi, Hattori Masaya, Yoshimura Akiyo, Yonemori Kan, Aizawa Mana, Mori Yuko, Yoshimitsu Junichiro, Umeyama Yoshiko, Mukohara Toru
Primary Institution: Aichi Cancer Center Hospital
Hypothesis
The study investigates the safety, pharmacokinetics, and antitumor activity of vepdegestrant in Japanese patients with ER+/HER2- advanced breast cancer.
Conclusion
Vepdegestrant 200 mg QD was well tolerated in Japanese patients with ER+/HER2- advanced breast cancer with no notable differences in pharmacokinetics from Western patients.
Supporting Evidence
- Six female patients were treated with a median age of 58 years.
- No dose-limiting toxicities were observed.
- 66.7% of patients experienced treatment-related adverse events, all of which were grade 1 or 2.
- Two patients demonstrated stable disease at week 24.
- Vepdegestrant showed no notable differences in pharmacokinetics compared to Western patients.
Takeaway
This study tested a new medicine called vepdegestrant on six women with a type of breast cancer, and it was found to be safe and well-tolerated.
Methodology
This was an open-label, nonrandomized, phase 1 study conducted at three sites in Japan, evaluating safety, pharmacokinetics, and antitumor activity.
Limitations
The small sample size and short duration of follow-up limit the interpretation of the preliminary antitumor activity.
Participant Demographics
All participants were female, with a median age of 58 years.
Digital Object Identifier (DOI)
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