^
Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | tibremciclib (BPI-16350) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer
Excerpt:
...- Has the pathologically-confirmed diagnosis of locally advanced, recurrent or metastatic, HR positive, HER2 negative Breast Cancer...
Trial ID:
Source:
Title:
BPI-16350, a novel promising CDK4/6 inhibitor for HR+/HER2- metastatic breast cancer (MBC): Results from a phase I study.
Published date:
05/25/2023
Excerpt:
In Part B, 46 pts with HR+/HER2- MBC were enrolled (300 mg, n=9; 400 mg, n=37), and 63.0% (29/46) of pts were still on treatment...Among the 46 pts, 43 pts were evaluable for efficacy. The DCR was 97.7% (42/43, 95% CI: 87.7%-99.9%). The confirmed overall response rate was as high as 60.5% (26/43, 95% CI: 44.4%-75%)...To our knowledge, BPI-16350 plus FUL demonstrated numerically highest antitumor activity compared with the already approved CDK4/6 inhibitors and less Grade ≥ 3 diarrhea than abemaciclib.
Secondary therapy:
fulvestrant
DOI:
10.1200/JCO.2023.41.16_suppl.e13051
Trial ID:
