Clinical Trials Directory

Trials / Terminated

TerminatedNCT03584009

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

A Phase II, Multicenter, Randomized Study To Compare The Efficacy Of Venetoclax Plus Fulvestrant Versus 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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
103 (actual)
Sponsor
Hoffmann-La Roche · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGVenetoclaxVenetoclax was administered orally, 800-mg tablet beginning on Cycle 1 Day 1 until the 9th October 2020.
DRUGFulvestrantFulvestrant was administered orally, 500 mg administered as two 250-mg IM injections on Cycle 1 Days 1 and 15 and on Day 1 of each subsequent 28-day cycle

Timeline

Start date
2018-09-06
Primary completion
2020-08-05
Completion
2021-05-06
First posted
2018-07-12
Last updated
2022-06-28
Results posted
2021-09-27

Locations

40 sites across 5 countries: United States, Australia, Canada, Germany, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT03584009. Inclusion in this directory is not an endorsement.