Cardiotoxicity of Cancer Therapy (CCT)

NCT01173341 | Enrolling By Invitation DMC

• 1 other identifier: UPCC 09110
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to define the clinical significance of mechanistic biomarkers (including Neuregulin-1Beta) and novel echocardiographic measures of cardiac function in predicting the incident risk of cancer therapy cardiotoxicity.

Conditions

Breast Cancer

Keywords

Chemotherapy-induced cardiotoxicity; Anthracycline; Trastuzumab

Outcome Measures

Primary Outcomes (1)

• Cardiac dysfunction or signs or symptoms of heart failure

  Cardiac dysfunction. as defined according to the Cardiac Review and Evaluation Committee (CREC) criteria as a decline in LVEF of 10% to less than 55% without signs or symptoms

  15 years

Secondary Outcomes (1)

• Change in quantitated Left Ventricular Ejection Fraction (LVEF)

  15 years

Study Arms (3)

Subgroup 2

Subgroup2 represents will undergo trastuzumab therapy only

Diagnostic Test: Echocardiography; Other: Blood Collection; Other: Symptoms Questionnaire

Subgroup 1

Subgroup 1 are anthracycline only treated patients.

Diagnostic Test: Echocardiography; Other: Blood Collection; Other: Symptoms Questionnaire

Subgroup 3

Subgroup 3 are patients that will undergo trastuzumab therapy with anthracyclines.

Diagnostic Test: Echocardiography; Other: Blood Collection; Other: Symptoms Questionnaire

Interventions

Echocardiography DIAGNOSTIC_TEST

Prior to chemotherapy, prior to and after anthracyclines, every 6 weeks during trastuzumab, and yearly for up to 10 years.

Subgroup 1; Subgroup 2; Subgroup 3

Blood Collection OTHER

Drawn at first chemo treatment and periodically during treatment (exact schedule varies with clinically ordered treatment plan), then annually for up to 10 years. Blood is banked for future biomarker testing.

Subgroup 1; Subgroup 2; Subgroup 3

Symptoms Questionnaire OTHER

Survey collected at first chemotherapy, periodically during therapy (exact schedule determined by clinically ordered treatment regimen), and annually for up to 10 years.

Subgroup 1; Subgroup 2; Subgroup 3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with breast cancer will enter the cohort prior to chemotherapy initiation and be evaluated at baseline and at regular intervals during the first approximately 15 months after chemotherapy is initiated. Patients will have study visits at 2 years, 3 years, 5, years, 7 years, 9 years, 11 years, 13 years, and 15 years following initiation of cancer therapy.

You may qualify if:

• Age 18 years or older
• HER-2 positive breast cancer designated to receive trastuzumab chemotherapy with or without prior exposure to anthracycline-based chemotherapy
• Non-HER-2 positive breast cancer designated to receive treatment with an anthracycline-containing regimen

You may not qualify if:

• Other contraindications to trastuzumab or anthracycline chemotherapy.
• Vulnerable populations

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Demissei BG, Hubbard RA, Zhang L, Smith AM, Sheline K, McDonald C, Narayan V, Domchek SM, DeMichele A, Shah P, Clark AS, Fox K, Matro J, Bradbury AR, Knollman H, Getz KD, Armenian SH, Januzzi JL, Tang WHW, Liu P, Ky B. Changes in Cardiovascular Biomarkers With Breast Cancer Therapy and Associations With Cardiac Dysfunction. J Am Heart Assoc. 2020 Jan 21;9(2):e014708. doi: 10.1161/JAHA.119.014708. Epub 2020 Jan 21.

  PMID: 31959034 DERIVED

• Upshaw JN, Finkelman B, Hubbard RA, Smith AM, Narayan HK, Arndt L, Domchek S, DeMichele A, Fox K, Shah P, Clark A, Bradbury A, Matro J, Adusumalli S, Carver JR, Ky B. Comprehensive Assessment of Changes in Left Ventricular Diastolic Function With Contemporary Breast Cancer Therapy. JACC Cardiovasc Imaging. 2020 Jan;13(1 Pt 2):198-210. doi: 10.1016/j.jcmg.2019.07.018. Epub 2019 Sep 18.

  PMID: 31542526 DERIVED

• Garcia-Pavia P, Kim Y, Restrepo-Cordoba MA, Lunde IG, Wakimoto H, Smith AM, Toepfer CN, Getz K, Gorham J, Patel P, Ito K, Willcox JA, Arany Z, Li J, Owens AT, Govind R, Nunez B, Mazaika E, Bayes-Genis A, Walsh R, Finkelman B, Lupon J, Whiffin N, Serrano I, Midwinter W, Wilk A, Bardaji A, Ingold N, Buchan R, Tayal U, Pascual-Figal DA, de Marvao A, Ahmad M, Garcia-Pinilla JM, Pantazis A, Dominguez F, John Baksi A, O'Regan DP, Rosen SD, Prasad SK, Lara-Pezzi E, Provencio M, Lyon AR, Alonso-Pulpon L, Cook SA, DePalma SR, Barton PJR, Aplenc R, Seidman JG, Ky B, Ware JS, Seidman CE. Genetic Variants Associated With Cancer Therapy-Induced Cardiomyopathy. Circulation. 2019 Jul 2;140(1):31-41. doi: 10.1161/CIRCULATIONAHA.118.037934. Epub 2019 Apr 16.

  PMID: 30987448 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Echocardiography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Bonnie Ky, MD

  Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 2, 2010
• Study Start: July 1, 2010
• Primary Completion (Estimated): April 1, 2037
• Study Completion (Estimated): April 1, 2037
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)