NCT01724450

Brief Summary

The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after chemotherapy in breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

4.2 years

First QC Date

June 11, 2012

Last Update Submit

January 31, 2018

Conditions

Breast CancerHeart FailureCardiotoxicity

Keywords

Breast CancerHeart FailureCardiotoxicityBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle.

    96 weeks

Secondary Outcomes (1)

  • Prevention of myocardial injury measured by the levels of biomarkers (ultrasensitive troponin, BNP and miRNA-208) Effect of carvedilol in the prevention of diastolic dysfunction.

    96 weeks

Study Arms (2)

Carvedilol

ACTIVE COMPARATOR
Drug: Carvedilol

Control

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CarvedilolDRUG

50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day

Carvedilol
PlaceboDRUG

Placebo similar to the carvedilol up titration but wit no active drug.

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with breast cancer, with an indication of chemotherapy that includes anthracycline.

You may not qualify if:

  • Failure analysis of ventricular function; History of chemotherapy or radiotherapy; Previous symptoms of heart failure; Presence of cardiomyopathy; Presence of Coronary Artery Disease; Aortic valve disease or moderate to severe mitral regurgitation; Contraindication to the use of β-blocker; Use of inhibitors of angiotensin converting enzyme, angiotensin receptor blockers or β-blockers.
  • Patients with HER 2 expression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute University of Sao Paulo

São Paulo, 05403-000, Brazil

Location

Related Publications (2)

  • Wanderley MRB Jr, Avila MS, Fernandes-Silva MM, Cruz FDD, Brandao SMG, Rigaud VOC, Hajjar LA, Filho RK, Cunha-Neto E, Bocchi EA, Ayub-Ferreira SM. Plasma biomarkers reflecting high oxidative stress in the prediction of myocardial injury due to anthracycline chemotherapy and the effect of carvedilol: insights from the CECCY Trial. Oncotarget. 2022 Jan 25;13:214-223. doi: 10.18632/oncotarget.28182. eCollection 2022.

    PMID: 35087624DERIVED

  • Avila MS, Ayub-Ferreira SM, de Barros Wanderley MR Jr, das Dores Cruz F, Goncalves Brandao SM, Rigaud VOC, Higuchi-Dos-Santos MH, Hajjar LA, Kalil Filho R, Hoff PM, Sahade M, Ferrari MSM, de Paula Costa RL, Mano MS, Bittencourt Viana Cruz CB, Abduch MC, Lofrano Alves MS, Guimaraes GV, Issa VS, Bittencourt MS, Bocchi EA. Carvedilol for Prevention of Chemotherapy-Related Cardiotoxicity: The CECCY Trial. J Am Coll Cardiol. 2018 May 22;71(20):2281-2290. doi: 10.1016/j.jacc.2018.02.049. Epub 2018 Mar 11.

    PMID: 29540327DERIVED

MeSH Terms

Conditions

Breast NeoplasmsHeart FailureCardiotoxicity

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Officials

  • Edimar Alcides Bocchi, PHD

    Heart Institute of University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phd

Study Record Dates

First Submitted

June 11, 2012

First Posted

November 9, 2012

Study Start

April 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

February 5, 2018

Record last verified: 2018-01

Locations

BR(1)