30May

Phase II trial of bicalutamide in combination with palbociclib for the treatment of androgen receptor (+) metastatic breast cancer.


Abstract No : 1017

Abstract Type : Poster Discussion Session

Indication : Triple Negative Breast Cancer

Intervention : bicalutamide + palbociclib

Company : Pfizer

Technology : Small Molecule


Results:

As of 1.1.20 33 pts were enrolled on study with median (med) age 67 (42-79), performance status 0 (0-1). Number of pts with visceral metastases: 20, measurable disease: 22. AR% 1-9: 3, 10-50: 6; 51-100: 24. Med prior lines for MBC: 3 (0-9). Best response: (31 evaluable pts): 11 pts PF at 6mo: 10 SD . 6mo, 1 PR. Med wks on study: 14 (2-101). Toxicity . 10% grade .3 related: Number of pts with leukopenia: 21, neutropenia: 21, lymphocytopenia: 6, thrombocytopenia: 3. One pt with febrile neutropenia. One death due to disease progression within 30 days off study


Conclusion:

In this selected subset of pts with AR+ TN MBC, this study met its prespecified endpoint with 11 pts PF at 6 mo on B 150 mg + P 125 mg. B+P has been well tolerated with no unexpected toxicity observed.


Commentary:

Finally there is some development in AR+ metastatic Triple Negative Breast Cancer as bicalutamide + palbociclib has shown activity in these patient sub group with high unmet need. Further studies are needed to develop predictive biomarker.


Refer to Triple Negative Breast Cancer Market report for detailed Insights.