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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05063643
Other study ID # SL-2020076
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2021
Est. completion date December 2024

Study information

Verified date September 2021
Source Affiliated Hospital of Qinghai University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
High altitude
High altitude is defined as >2000m.

Locations

Country Name City State
China Affiliated Hospital of Qinghai University Xining Qinghai

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital of Qinghai University

Country where clinical trial is conducted

China, 

Outcome

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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