Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2022-06-30

Brief Summary

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The aim of the study is to analyze the protective impact on the cardiac damage of beta blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based chemotherapy with or without trastuzumab.

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Detailed Description

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Over the years, due to the use of new generation therapeutic regimens, as well as the use of advanced radiation techniques, the curability of breast cancer reached an overall 10-year survival rate of approximately 80%.

Anthracyclines have a key role in the treatment of breast cancer. Many published studies showed a benefit of disease-free survival in patients with positive lymph nodes treated with anthracyclines-based regimens. Many anthracyclines and taxanes-based regimens are currently used in clinical practice in the treatment of breast cancer. Numerous randomized trials have confirmed the benefit of the addition of taxanes to anthracyclines.

Trastuzumab is a recombinant humanized monoclonal antibody with specificity for the extracellular domain of human epidermal growth factor receptor 2 (HER2). The use of trastuzumab administered sequentially or concurrently with adjuvant chemotherapy compared to chemotherapy in patients with HER2 positive was evaluated in several randomized trials. Many data concerning the incidence of adverse cardiovascular events acute, subacute and late are now available. The cardiac toxicity of anthracyclines may be acute, subacute and chronic. The acute toxicity occurs during or shortly after the infusion of the drug with arrhythmias, which in some cases leads to heart failure, pericarditis-myocarditis and electrocardiographic abnormalities. The acute toxicity is usually reversible in a dose-dependent manner. The acute and subacute toxicity are rare (1-4%). Data are available concerning clinically relevant cardiac toxicity with a chronic progressive deterioration of ventricular function up to heart failure.

Beside the cumulative dose risk factor, other unfavourable features such as advanced age, female sex, and the combination of anthracyclines and trastuzumab should be evaluated. In most cases, the late toxicity occurs within the first year following completion of chemotherapy but nevertheless the clinical manifestations can occur even after 10-20 years. This fact suggests that in women treated in (neo)adjuvant setting is strongly necessary an echocardiographic monitoring even after a longer time.

The aim of the study is to analyze the protective impact on the cardiac damage of beta blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based chemotherapy with or without trastuzumab, using myocardial strain imaging monitoring.

Conditions

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Breast Cancer Cardiotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Both participants and Care Providers are not aware of intervention allocation.

Study Groups

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Arm 1

bisoprolol plus ramipril

Group Type EXPERIMENTAL

Bisoprolol

Intervention Type DRUG

5 mg daily

Ramipril

Intervention Type DRUG

5 mg daily

Arm 2

Bisoprolol plus placebo

Group Type ACTIVE_COMPARATOR

Bisoprolol

Intervention Type DRUG

5 mg daily

Placebo

Intervention Type DRUG

1 capsule daily

Arm 3

Ramipril plus placebo

Group Type ACTIVE_COMPARATOR

Ramipril

Intervention Type DRUG

5 mg daily

Placebo

Intervention Type DRUG

1 capsule daily

Arm 4

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 capsule daily

Interventions

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Bisoprolol

5 mg daily

Intervention Type DRUG

Ramipril

5 mg daily

Intervention Type DRUG

Placebo

1 capsule daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female
* Age \>18 years
* Non-metastatic histologically confirmed primary invasive breast cancer
* Scheduled to receive neoadjuvant and/or adjuvant anthracyclines with or without anti-HER2 therapy
* Provided informed consent
* Able to swallow capsules
* LVEF \> 50%

Exclusion Criteria

* Pregnant or lactating women
* Treatment with ACE-inhibitors or beta blockers at diagnosis
* History of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) (version 4.0) Grade \>2 symptomatic congestive heart failure (CHF), previous myocardial infarction, significant symptoms (Grade\>2) relating to LVEF dysfunction, valvular disease, cardiac arrhythmia (Grade\>3)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No