drugset / Trial / NCT05894239
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
Timeline
- Start
- 2023-09-08
- Primary completion
- 2026-12-31
- Completion
- 2032-12-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inavolisib | Small molecule | — | Oral |
| Background | Anastrozole | Other / unclassified | — | — |
| Background | Exemestane | Small molecule | — | — |
| Background | Fulvestrant | Small molecule | — | — |
| Background | Letrozole | Other / unclassified | — | — |
| Background | Phesgo | Unknown | — | Subcutaneous |
| Background | Tamoxifen | Small molecule | — | — |