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NCT03123263

Echocardiographic Changes During Adjuvant Therapy in Hispanic Women With Her-2 Neu Expressing Breast Cancer

Completed Results posted Last updated 9 September 2019
What this trial tests

trial in Breast Cancer in 60 participants. Completed in 26 February 2019.

Timeline
11 April 2017
Primary endpoint
26 February 2019
26 February 2019

Quick facts

Lead sponsorTexas Tech University Health Sciences Center, El Paso
StatusCompleted
Study typeOBSERVATIONAL
Enrollment60
Start date11 April 2017
Primary completion26 February 2019
Estimated completion26 February 2019
Sites1 location across United States

Conditions studied

Sponsor

Texas Tech University Health Sciences Center, El Paso

Who can join

Adults 18 to 90, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

LVEF Primary · Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy)

LV ejection fraction

GroupValue95% CI
Patients65.4± .844
LVEF at 3-6months64.7± .724
LVEF End of Therapy62.2± .81
Number of Participants Hospitalized for Cardiac Issues. Secondary · 1 year

any hospitalization for cardiac issues

GroupValue95% CI
Hospitalizations Due to Cardiac Complications0

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Trastuzumab-treated Breast Cancer Patients
Serious: 2/60 (3%)
Deaths: 0/60

Serious adverse events (1 terms)

ReactionSystemTrastuzumab-treated Breast…
LVEF declineCardiac disorders

Most-reported serious reactions: LVEF decline.

Data from ClinicalTrials.gov NCT03123263 adverse events section.

Sponsor's own description

This study retrospectively looks at changes in Echocardiographic parameters while using transtuzumab

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Texas Tech University Health Sciences Center, El Paso trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03123263.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing