HER2-positive Breast Cancer Clinical Trial
Official title:
Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High altitude-a Multicenter, Prospective Cohort Study
Verified date | September 2021 |
Source | Affiliated Hospital of Qinghai University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 132 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Qinghai University | Xining | Qinghai |
Lead Sponsor | Collaborator |
---|---|
Affiliated Hospital of Qinghai University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence rate of cardiotoxicity | Cardiotoxicity includes death from cardiac cause, severe congestive heart failure (New York Heart Association Class III or IV), more than 10% decrease of left ventricular ejection fraction (LVEF) and to below 50%, and an asymptomatic or mildly symptomatic (NYHA class II) substantial decrease in LVEF. | 5 years | |
Secondary | pCR rate | Pathologic complete response (pCR) rate in patients received neoadjuvant therapy | 4 years | |
Secondary | ORR | Objective remission rate in patients received neoadjuvant and palliative therapy | 4 years | |
Secondary | DCR | Disease control rate in patients received neoadjuvant and palliative therapy | 4 years | |
Secondary | OS | Overall survival of the enrolled patients | 5 years | |
Secondary | the incidence of treatment-related adverse events | Incidence and Severity of adverse events according to the CTC AE V4.03 Incidence and Severity of adverse events according to the CTC AE V4.03 Incidence and severity of adverse events according to the CTC AE V4.03 | 5 years |
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