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
Public ClinicalTrials.gov record NCT03584009. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03584009
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 103 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 6, 2018 (Actual)
- Primary completion
- Aug 5, 2020 (Actual)
- Completion
- May 6, 2021 (Actual)
- Last update posted
- Jun 28, 2022
2018 – 2021
United States locations
- U.S. sites
- 21
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | — |
| UC San Deigo Moores Cancer Center | La Jolla | California | 92037 | — |
| Comprehensive Cancer Center at Desert Regional Medical Center | Palm Springs | California | 92262 | — |
| St. Joseph Health Medical Group - Annadel Medical Group | Santa Rosa | California | 95403-1757 | — |
| Sylvester Comprehensive Cent. | Miami | Florida | 33136 | — |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | — |
| Kaiser Permanente - Moanalua Medical Center | Honolulu | Hawaii | 96819-1469 | — |
| Ashland-Bellefonte Cancer Center | Ashland | Kentucky | 41101-7016 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114 | — |
| Mass General/North Shore Cancer | Peabody | Massachusetts | 01960 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Nebraska Hematology Onco, PC | Lincoln | Nebraska | 68506 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Sanford Health System | Sioux Falls | South Dakota | 57105 | — |
| The University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| The Center for Cancer and Blood Disorders - Fort Worth | Fort Worth | Texas | 76104 | — |
| Millennium Research & Clinical Development | Houston | Texas | 77090 | — |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03584009, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 28, 2022 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03584009 live on ClinicalTrials.gov.