drugset / Trial / NCT05498896
Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC
Phase 2
Active not recruiting
146 enrolled
Queen Mary University of London
Hoffmann-La Roche · collabMedSIR · collabWestdeutsche Studiengruppe GmbH (WSG) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
International, randomised, open label, neo-adjuvant phase II trial in women with newly diagnosed, non-metastatic, high-risk (node positive and/or tumour size ≥ 2cm), triple negative breast cancer. The study aims to evaluate the effects of adding ipatasertib to chemotherapy and atezolizumab in patients with and without PI3CA/AKT1/PTEN genetic alterations.
Timeline
- Start
- 2018-12-19
- Primary completion
- 2026-08-31
- Completion
- 2026-08-31
Publications
- Results P. Schmid, F.J. Salvador Bofill, B. Bermejo, et al. BARBICAN: A randomized, phase II study to determine the contribution of ipatasertib to neoadjuvant chemotherapy plus atezolizumab in women with triple-negative breast cancer. Annals of Oncology (2021) 32 (suppl_5): S407-S446. 10.1016/annonc/annonc687
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipatasertib | Small molecule | 400 mg | Oral |
| Background | Atezolizumab | Monoclonal antibody | 840 mg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |