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NCT02993198 · ClinicalTrials.gov registry record · Phase 2
A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging
A Phase 2 study of HER2-positive Breast Cancer and Cardiovascular Abnormalities, sponsored by Northwestern University.
- Active
- Registry status
- Phase 2
- Development phase
- 134
- Enrollment target
- 1
- Study location
NCT02993198 is a Phase 2 study of HER2-positive Breast Cancer and Cardiovascular Abnormalities that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 134 participants, below the 237-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02993198, a Phase 2 study of HER2-positive Breast Cancer and Cardiovascular Abnormalities, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 134 participants
- Enrollment target
- 1
- Study location
Study Summary
The Cardio-Oncology program at Northwestern offers care to cancer patients who develop cardiac toxicities from chemotherapy. Breast cancer patients with the tumor marker for HER2 necessitate treatment with anthracycline and/or trastuzumab and pertuzumab-based chemotherapies, which are known to cause cardiac toxicities. Breast cancer patients will undergo a "cardio-oncology echocardiogram" which incorporates advanced left ventricular assessment by utilizing deformation or strain imaging during chemotherapy treatment for surveillance of cardiac toxicities. The aims of this project are: 1. To create a registry of both clinical, and echocardiographic variables, biomarkers, and genetic analysis that will be used to develop a risk model to predict LV dysfunction in early stage breast cancer patients undergoing chemotherapy with anthracycline and/or trastuzumab and pertuzumab-based chemotherapy regimens. 2. To propose a new management algorithm for initiation of prophylactic beta-blocker therapy for early stage breast cancer patients with preclinical cardiac toxicities demonstrated by strain parameters. 3. To determine if initiation of prophylactic beta-blocker therapy in patients with early cardiac toxicity can delay or prevent a drop in LV EF and the development of clinical heart failure. 4. To explore serial measurements of a suite of novel biomarkers during ongoing anticancer treatment that are presumed but not yet proven to be predictive of cardiac dysfunction in women with breast cancer. 5. To identify DNA biomarkers of predilection to cardiotoxicity. 6. To generate hiPSC to validate markers predictive of cardiotoxicity.
Conditions Studied
Interventions
- DRUG Carvedilol
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2015-04 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02993198
The ClinicalTrials.gov registry entry for NCT02993198 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 237-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (43% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Carvedilol is the first listed.
NCT02993198 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT02993198 about?
NCT02993198 is a clinical study titled "A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging". The Cardio-Oncology program at Northwestern offers care to cancer patients who develop cardiac toxicities from chemotherapy. Breast cancer patients with the tumor marker for HER2 necessitate treatment with anthracycline and/or trastuzumab and pertuzumab-based chemotherapies, which are known to cause...
What is the current status of trial NCT02993198?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2015-04. Estimated completion is 2025-12.
What conditions does trial NCT02993198 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer, Cardiovascular Abnormalities.
What interventions are being tested in trial NCT02993198?
The interventions under investigation include: Carvedilol (DRUG).
Who is sponsoring clinical trial NCT02993198?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02993198 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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