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Testing the Addition of a Blood Pressure Medication, Carvedilol, to HER-2 Targeted Therapy for Metastatic Breast Cancer to Prevent Cardiac Toxicity


Active: Yes
Cancer Type: Breast Cancer NCT ID: NCT03418961
Trial Phases: Phase III Protocol IDs: S1501 (primary)
S1501
SWOG-S1501
NCI-2016-01047
Eligibility: 18 Years and older, Male and Female Study Type: Supportive care
Study Sponsor: SWOG
NCI Full Details: http://clinicaltrials.gov/show/NCT03418961

Summary

This phase III trial studies compares prophylactic beta blocker therapy with carvedilol versus no prophylaxis in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body (metastatic). A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may protect the heart from the side effects of chemotherapy.

Objectives

PRIMARY OBJECTIVE:
I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no prophylaxis reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab–based HER-2 targeted therapy.

SECONDARY OBJECTIVES:
I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no prophylaxis reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab–based HER-2 targeted therapy.
II. To evaluate if prophylactic carvedilol compared with no prophylaxis results in a longer time to first interruption of trastuzumab–based HER-2 targeted therapy due to either cardiac dysfunction or events.
III. To assess whether prophylactic beta blocker therapy with carvedilol compared with no prophylaxis reduces the risk of subsequent cardiac dysfunction OR events in this population.
IV. To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction.
V. To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons.
VI. To compare the local and central reads of left ventricular ejection fraction (LVEF) and strain and assess if strain changes can predict drop in ejection fraction.
VII. Assess if strain can be used in the community as a marker of cardiotoxicity.

TRANSLATIONAL OBJECTIVES:
I. To evaluate the isoleucine (lle) 655 valine (Val) and alanine (Ala)ll70 proline (Pro) single nucleotide polymorphisms (SNPs) of the HER-2 gene as a predictive biomarker of study-defined cardiac dysfunction.
II. To evaluate plasma neuregulin-1 at baseline and over study time as a predictive biomarker of study-defined cardiac dysfunction.
III. To evaluate the feasibility of local labs performing serial left ventricular strain in a National Clinical Trials Network (NCTN) group setting, with the goal of 75% of patients contributing both a baseline and at least one follow-up strain measurement.
IV. To bank blood for future translational medicine studies such as brain natriuretic peptide (BNP), additional SNPs, and high sensitivity troponin.

OUTLINE: Patients are randomized to 1 of 2 arms. Patients taking beta blocker, ARB, or ACE inhibitor at registration are assigned to Arm III.

ARM I: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive carvedilol orally (PO) twice daily (BID). Cycles repeat every 12 weeks for 108 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks.

ARM III (CLOSED TO ACCRUAL 7/7/21): Patients undergo observation for up to 108 weeks.

After completion of study, patients are followed up every 12 weeks for up to 108 weeks.

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta
3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
770-777-1315
www.atlantacancercare.com



Atlanta Cancer Care - Conyers
1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com



Atlanta Cancer Care - Cumming
1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041
www.atlantacancercare.com



Atlanta Cancer Care - Decatur
2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Doctors:


Atlanta Cancer Care - Stockbridge
7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com



Atlanta Cancer Care - Tower
5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com



Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org



Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org



Georgia Cancer Specialists - Athens
125 King Avenue
Suite 200
Athens, GA 30606
www.gacancer.com



Georgia Cancer Specialists - Canton
228 Riverstone Drive
Canton, GA 30114
www.gacancer.com



Georgia Cancer Specialists - CenterPointe
1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com



Georgia Cancer Specialists - Kennestone
790 Church Street
Suite 335
Marietta, GA 30060
www.gacancer.com



Georgia Cancer Specialists - Macon-Coliseum
308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com



Georgia Cancer Specialists - Stemmer
2712 Lawrenceville Highway
Decatur, GA 30033
770-496-5555
www.gacancer.com



Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org



Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com



Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.