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Association details:
| Biomarker: | PIK3CA mutation + HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | bireociclib (XZP 3287) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A multicenter, single-arm, open-label trial of birociclib, a CDK4/6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer.
Published date:
05/25/2023
Excerpt:
The investigator-assessed confirmed ORR was 22.9% (95% CI: 16.0-31.1); DCR was 66.4% (95% CI: 57.6-74.4); CBR was 39.7% (95% CI: 31.3-48.6), among which 1 (0.8%) patient was with confirmed complete response (CR) and 29 (22.1%) patients were with confirmed partial response (PR)....In patients who have limited treatment options with refractory HR+/HER2- metastatic breast cancer, continuous dosing of single-agent Birociclib exhibited promising and sustaining clinical activity with acceptable safety profile, thus it provided an alternative orally administered therapy option.
DOI:
10.1200/JCO.2023.41.16_suppl.1072
Trial ID:
