Cardiotoxicity of Adjuvant Trastuzumab (CATS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shom Goel, Royal Prince Alfred Hospital, Sydney, Australia
ClinicalTrials.gov Identifier:
NCT00858039
First received: March 6, 2009
Last updated: April 14, 2013
Last verified: April 2013
  Purpose

Trastuzumab (Herceptin®) increases the chances of cure in patients with Her-2 overexpressing early breast cancer. Unfortunately, both the chemotherapy drugs used in this setting (anthracyclines) and trastuzumab are known to cause cardiac dysfunction in a proportion of patients. Patients who develop heart problems when taking trastuzumab might have to stop this treatment, which could jeopardise their chances of cure. N-terminal pro-B-type natriuretic peptide (NT pro-BNP) is a cardiac biomarker that is measured in the blood, the levels of which have been shown to indicate the presence of heart failure. Some early research has suggested that there may be a correlation between elevated NT pro-BNP and heart damage due to cancer chemotherapy and also trastuzumab. Troponin is another substance measured in the blood that can indicate heart damage. Finally, certain variations in an individual's genetic makeup (called polymorphisms) could put them at increased risk of heart damage from trastuzumab. Here we are studying whether any of these factors (NT pro-BNP levels, troponin levels, or certain genetic polymorphisms) can accurately predict who is at highest risk of trastuzumab-related cardiotoxicity.

The principal aim of this study is to evaluate the utility of NT pro-BNP as a predictive biomarker for the development of trastuzumab related cardiotoxicity (TRC). The investigators will also examine if single nucleotide polymorphisms in the HER2 gene or Fc-gamma-receptor genes predict for TRC.


Condition
Breast Neoplasms
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Cardiotoxicity Using Serum N-terminal Pro-B-type Natriuretic Peptide in Breast Cancer Patients Receiving Adjuvant Trastuzumab

Resource links provided by NLM:


Further study details as provided by Royal Prince Alfred Hospital, Sydney, Australia:

Primary Outcome Measures:
  • Cardiotoxicity (Cardiac death; grade 3/4 arrhythmia or ischaemia; NYHA Class 3 or 4 heart failure decline in LVEF by >10% to a level <55%; decline in LVEF by >5% to a level <50%) [ Time Frame: Until 6 months after completing trastuzumab ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Human serum Human whole blood


Enrollment: 220
Study Start Date: February 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Her-2 positive ESBC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting to tertiary referral medical oncology clinics

Criteria

Inclusion Criteria:

  • Female 18 years or older
  • Histologically confirmed, completely excised invasive breast cancer with Her-2 overexpression
  • Primary surgery less than twelve weeks prior to registration
  • LVEF>50% as assessed by transthoracic echocardiogram or gated heart pool scan
  • Eastern Cooperative Oncology Group Performance Status 0-2
  • Adjuvant systemic treatment plan comprises at least three cycles of anthracycline chemotherapy AND 52 weeks of trastuzumab
  • Before patient registration, informed consent must be given according to local regulations.

Exclusion Criteria:

  • Pregnancy
  • Distant metastases from breast cancer
  • Any systemic chemotherapy prior to study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858039

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Concord Hospital
Sydney, New South Wales, Australia, 2137
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
Sutherland Hospital
Sydney, New South Wales, Australia, 2232
St George Private Hospital
Sydney, New South Wales, Australia, 2217
Sydney Haematology Oncology Clinic
Sydney, New South Wales, Australia, 2077
Macarthur Cancer Therapy Centre
Sydney, New South Wales, Australia, 2560
Bankstown Hospital
Sydney, New South Wales, Australia, 2200
Nepean Cancer Care Centre
Sydney, New South Wales, Australia, 2750
Royal North Shore Private Hospital
Sydney, New South Wales, Australia, 2065
Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Australia, Queensland
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4029
Australia, Victoria
Andrew Love Cancer Centre
Geelong, Victoria, Australia, 3220
Warnambool Hospital
Warnambool, Victoria, Australia
Australia, Western Australia
The Mount Hospital
Perth, Western Australia, Australia, 6805
Sponsors and Collaborators
Royal Prince Alfred Hospital, Sydney, Australia
Investigators
Study Director: Jane Beith, MBBS FRACP PhD Sydney South West Area Health Service (Royal Prince Alfred Hospital)
  More Information

No publications provided

Responsible Party: Shom Goel, Breast Oncology Fellow, Royal Prince Alfred Hospital, Sydney, Australia
ClinicalTrials.gov Identifier: NCT00858039     History of Changes
Other Study ID Numbers: X08-0296
Study First Received: March 6, 2009
Last Updated: April 14, 2013
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Heart Failure
Neoplasms by Site
Breast Diseases
Skin Diseases
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Trastuzumab
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014