drugset / Trial / NCT02123823
BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose, and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in combination with exemestane in women with HR+/HER2- advanced breast cancer
Timeline
- Start
- 2014-05-15
- Primary completion
- 2016-11-25
- Completion
- 2021-12-14
Publications
- Dercle L, McGale J, Zhao B, Schmitt J, Peltzer A, Schwartz LH, Amend M. Artificial intelligence and radiomics biomarkers for treatment response prediction in advanced HER2-negative breast cancer. Breast. 2025 Dec;84:104571. doi: 10.1016/j.breast.2025.104571. Epub 2025 Sep 3.
- Schmid P, Sablin MP, Bergh J, Im SA, Lu YS, Martinez N, Neven P, Lee KS, Morales S, Perez-Fidalgo JA, Adamson D, Goncalves A, Prat A, Jerusalem G, Schlieker L, Espadero RM, Bogenrieder T, Huang DC, Crown J, Cortes J. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. Breast Cancer Res. 2021 Jan 15;23(1):8. doi: 10.1186/s13058-020-01382-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Xentuzumab | Monoclonal antibody | 750 mg | Intravenous |
| Subject | Xentuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Everolimus | Small molecule | 10 mg | Oral |
| Background | Exemestane | Small molecule | 25 mg | Oral |