Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT03939897. 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 Randomized Phase I/II Trial of Fulvestrant and Abemaciclib in Combination With Copanlisib (FAC) Versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine-Resistant, Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (FAC vs FA)
Study identification
- NCT ID
- NCT03939897
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- National Cancer Institute (NCI)
- NIH
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Interventions
- Abemaciclib Drug
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Copanlisib Hydrochloride Drug
- Diagnostic Imaging Testing Procedure
- Echocardiography Test Procedure
- Fulvestrant Drug
- Multigated Acquisition Scan Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Jun 16, 2020
- Primary completion
- Jun 21, 2023
- Completion
- Aug 13, 2026
- Last update posted
- Apr 28, 2026
2020 – 2026
United States locations
- U.S. sites
- 14
- U.S. states
- 7
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| UC Irvine Health Cancer Center-Newport | Costa Mesa | California | 92627 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | — |
| Bellevue Hospital Center | New York | New York | 10016 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Wake Forest University at Clemmons | Clemmons | North Carolina | 27012 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03939897, 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 Apr 28, 2026 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03939897 live on ClinicalTrials.gov.