Trial · NCT01009918

Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab

NCT01009918, Phase 2, Completed, University of South Florida; results first posted 2021-03-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab. Trials, record NCT01009918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01009918

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
NCT number: NCT01009918
Status: Completed
Phases: Phase 2
Enrollment: 468 participants, actual
Lead sponsor: University of South Florida
Conditions: Breast Cancer, Cardiac Toxicity
Interventions: Coreg CR®, lisinopril, placebo
First posted: 2009-11-09
Last updated: 2021-03-30
Results first posted: 2021-03-30

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment	2 years	Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of Left Ventricular Ejection Fraction (LVEF). Number of Patients who experienced a cardiotoxicity.
Primary	Number of Participants With LVEF Decrease to <50%	2 years	Number of Participants with Left Ventricular Ejection Fraction (LVEF) drop to \<50%
Secondary	Number of Patients With Trastuzumab Course Interruption	2 years	Measure indicates the number of patients who had an interruption of trastuzumab for any reason
Secondary	Quality-of-life Changes Between Baseline and 52-weeks	52 weeks	Quality-of-life changes as assessed by North European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), which measures the quality of life of cancer patients. Higher score indicates higher quality of life. Score range is 0-100. The questionnaire was administered at baseline and at 52 weeks.
Secondary	Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline	2 years	Number of Participants with cardiotoxicity-free survival at 750 days from baseline

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment	2 years	Number of participants who experienced cardiotoxicity	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With LVEF Decrease to <50%	2 years	LVEF drop to \<50%	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Trastuzumab Course Interruption	2 years	Number of patients who had an interruption of trastuzumab for any reason	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Quality-of-life Changes Between Baseline and 52-weeks	52 weeks	Mean change from baseline to 52-week endpoint	Scores on a scale	MEAN
SECONDARY	Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline	2 years	Number of Participants with cardiotoxicity-free survival at 750 days from baseline	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment	Arm I Lisinopril	45		Participants
Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment	Arm II Coreg CR®	43		Participants
Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment	Arm III Placebo	46		Participants
Number of Participants With LVEF Decrease to <50%	Arm I Lisinopril	5		Participants
Number of Participants With LVEF Decrease to <50%	Arm II Coreg CR®	9		Participants
Number of Participants With LVEF Decrease to <50%	Arm III Placebo	15		Participants
Number of Patients With Trastuzumab Course Interruption	Arm I Lisinopril	27		Participants
Number of Patients With Trastuzumab Course Interruption	Arm II Coreg CR®	24		Participants
Number of Patients With Trastuzumab Course Interruption	Arm III Placebo	40		Participants
Quality-of-life Changes Between Baseline and 52-weeks	Arm I Lisinopril	1	Standard Deviation 23	Scores on a scale

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I Lisinopril	158
Overall Study	STARTED	Arm II Coreg CR®	156
Overall Study	STARTED	Arm III Placebo	154
Overall Study	COMPLETED	Arm I Lisinopril	134
Overall Study	COMPLETED	Arm II Coreg CR®	132
Overall Study	COMPLETED	Arm III Placebo	124
Overall Study	NOT COMPLETED	Arm I Lisinopril	24
Overall Study	NOT COMPLETED	Arm II Coreg CR®	24
Overall Study	NOT COMPLETED	Arm III Placebo	30

Source ClinicalTrials.gov

Adverse events105

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Arm I Lisinopril	8	158	21
other	Anemia	Blood and lymphatic system disorders	Arm II Coreg CR®	11	156	18
other	Anemia	Blood and lymphatic system disorders	Arm III Placebo	6	154	8
other	Arthralgia	Musculoskeletal and connective tissue disorders	Arm I Lisinopril	9	158	10
other	Arthralgia	Musculoskeletal and connective tissue disorders	Arm II Coreg CR®	8	156	8
other	Arthralgia	Musculoskeletal and connective tissue disorders	Arm III Placebo	6	154	7
other	Constipation	Gastrointestinal disorders	Arm I Lisinopril	10	158	15
other	Constipation	Gastrointestinal disorders	Arm II Coreg CR®	13	156	14
other	Constipation	Gastrointestinal disorders	Arm III Placebo	5	154	5
other	Cough	Respiratory, thoracic and mediastinal disorders	Arm I Lisinopril	21	158	22

1 to 10 of 105Source ClinicalTrials.gov

See all 105 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I Lisinopril	1	158
Total, all-cause mortality	Arm II Coreg CR®	2	156
Total, all-cause mortality	Arm III Placebo	2	154
Total, other adverse events	Arm I Lisinopril	104	158
Total, other adverse events	Arm II Coreg CR®	89	156
Total, other adverse events	Arm III Placebo	82	154
Total, serious adverse events	Arm I Lisinopril	5	158
Total, serious adverse events	Arm II Coreg CR®	4	156
Total, serious adverse events	Arm III Placebo	6	154

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31171092	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA081920	SunCoast CCOP Research Base at the University of South Florida	KRISCHER, JEFFREY P	UNIVERSITY OF SOUTH FLORIDA	NATIONAL CANCER INSTITUTE	2000 to 2015

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01009918

GET https://conductscience.org/api/trials/v1/NCT01009918/events?page=2

API reference For AI assistants