common.study.topics.clinical

Treatment of Metastatic Breast Cancer

common.study.values.description

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

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, inoperable, locally advanced or MBC who experienced disease recurrence or progression during or after treatment with CDK4/6i therapy for at least 8 weeks.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Recruiting patients only common.study.methods.is-healthy-yes

Drug - Venetoclax

Venetoclax will be administered orally, 800-mg tablet beginning on Cycle 1 Day 1

Drug - Fulvestrant

Fulvestrant will be administered orally, 500 mg administered as two 250-mg intramuscular (IM) injections on Cycle 1 Days 1 and 15 and on Day 1 of each subsequent 28-day cycle

participant.views.study.view.additional

participant.views.study.view.scientific-title

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

common.study.values.clinical-trial-id

NCT03584009

participant.views.study.view.id

e5yy8e