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

Not yet recruiting

• Conditions: HER2-positive Breast Cancer; Targeted Therapy; Cardiac Toxicity; High Altitude

• Registration Number: NCT05063643
• Lead Sponsor: Affiliated Hospital of Qinghai University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-07-26
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-30
• Last Update Submitted: 2021-09-30
• Study Start: 2021-10
• Study First Posted: 2021-10-01
• Last Update Posted: 2021-10-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 132

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of cardiotoxicity	5 years	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.

Secondary Outcome Measures

Name	Time	Method
DCR	4 years	Disease control rate in patients received neoadjuvant and palliative therapy
pCR rate	4 years	Pathologic complete response (pCR) rate in patients received neoadjuvant therapy
ORR	4 years	Objective remission rate in patients received neoadjuvant and palliative therapy
OS	5 years	Overall survival of the enrolled patients
the incidence of treatment-related adverse events	5 years	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

Trial Locations

Locations (1)

Affiliated Hospital of Qinghai University; 🇨🇳 Xining, Qinghai, China