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NCT03939897 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer
A Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 14
- Study locations
NCT03939897: Active Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03939897 is a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (86% lower). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03939897, a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 14
- Study locations
Study Summary
This phase I trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread from where it first started (breast) to other places in the body (metastatic). Some breast cancer cells have receptors for the hormones estrogen or progesterone. These cells are hormone receptor positive and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Abemaciclib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding copanlisib to the usual therapy of fulvestrant and abemaciclib may work better than giving fulvestrant and abemaciclib alone in treating patients with breast cancer.
Primary Outcome
DLT will be determined based on the incidence, intensity and duration of adverse events (AEs) that are related to the drug combinations and occur within 28 days of drug administration. The severity of AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized by counts and percentages, overall as well as by dose levels and by patient characteristics.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- DRUG Abemaciclib
- PROCEDURE Diagnostic Imaging Testing
- DRUG Copanlisib Hydrochloride
Study Locations (14)
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
California
- UC Irvine Health Cancer Center-Newport - Costa Mesa
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
New York
- Bellevue Hospital Center - New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
North Carolina
- Wake Forest University at Clemmons - Clemmons
- Wake Forest University Health Sciences - Winston-Salem
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-06-17 |
| Est. Completion | 2026-08-14 |
| Phase | Phase 1 |
What the registry record for NCT03939897 still lists
NCT03939897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (86% lower).
The record links to 5 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03939897 lists 14 locations in 7 states (Missouri, California, New York).
Frequently Asked Questions
What is clinical trial NCT03939897 about?
NCT03939897 is a clinical study titled "Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer". This phase I trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread from where it first started (breast) to other places in the body (metasta...
What is the current status of trial NCT03939897?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-06-17. Estimated completion is 2026-08-14.
What conditions does trial NCT03939897 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma.
What interventions are being tested in trial NCT03939897?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Abemaciclib (DRUG), Diagnostic Imaging Testing (PROCEDURE), Copanlisib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03939897?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03939897 being conducted?
This trial has 14 study locations across Alabama, California, Kentucky, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03939897's enrollment target sits among peer trials
24 42nd of 59 higher than 17 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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