Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude

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

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-31

Study Completion Date

2024-12-31

Brief Summary

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This is a prospective, multicenter, cohort study aiming to explore the cardiotoxicity of targeted therapy for HER-2 positive breast cancer patients who lives in high altitude area. One hundred and thirty two HER-2 positive breast cancer patients who will receive neoadjuvant, adjuvant, or palliative targeted therapy will be enrolled. The cardiotoxicity of targeted therapy will be observed and recorded during the treatment and one year after the end of treatment. The subjects will be stratified by age, baseline cardiac risk factors, and anthracyclines.

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Detailed Description

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HER-2 positive breast cancer patients who live at high altitudes greater than 2000 meters for long periods of time and will receive trastuzumab-based targeted therapy will be enrolled. The subjects included early and advanced patients. Treatment regimens includes chemotherapy combined with trastuzumab, chemotherapy combined with trastuzumab and pertuzumab, trastuzumab alone, and trastuzumab plus pertuzumab. Electrocardiogram, cardiac ultrasound, NT-proBNP, and TNI will be tested every 3 months when the treatment begins. The primary endpoint is cardiotoxity. The second endpoints is pathologic complete response (pCR) rate in neoadjuvant therapy, objective remission rate (ORR) and disease control rate (DCR) in neoadjuvant and palliative therapy.

Conditions

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HER2-positive Breast Cancer Targeted Therapy Cardiac Toxicity High Altitude

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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High altitude

High altitude is defined as \>2000m.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Histologically confirmed invasive HER2-positive breast cancer.
2. The baseline left ventricular ejection fraction \>55%.
3. Living at high altitude area （\>2000 meters）for at least 10 years.
4. ECOG score 0-2.
5. Expected survival time ≥ 12 months.

Exclusion Criteria

1. Patients with previous breast cancer or other malignant tumor within 5 years.
2. Patients who had accepted previous anti-HER2 or anthracyclines-based therapy.
3. Patients with severe heart disease or discomfort.
4. Patients who are pregnant.
5. Patients with other conditions considered not suitable to be enrolled by the investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No