A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy
Summary
This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, locally advanced or Metastatic Breast Cancer (MBC) who experienced disease recurrence or progression during or after treatment with CDK4/6i therapy for at least 8 weeks. As of 9th October 2020, participants in the Venetoclax + Fulvestrant arm, have all discontinued Venetoclax treatment and have continued on Fulvestrant treatment alone.
Timeline
- Start
- 2018-09-06
- Primary completion
- 2020-08-05
- Completion
- 2021-05-06
Outcome
Missed primary endpoint
Stopped: “Sponsor's decision, no safety concerns.”
registry analysis (superiority test); Venetoclax + Fulvestrant vs Fulvestrant; p = 0.7286; Risk Difference (RD) -1.96 (95% CI -16.86 to 12.94) NCT03584009 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | 500 mg | Oral |
| Subject | Venetoclax | Small molecule | 800 mg | Oral |