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

Sponsor

Affiliated Hospital of Qinghai University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05063643

Collaborator

(none)

132

Enrollment

Location

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HER2-positive Breast Cancer Targeted Therapy Cardiac Toxicity High Altitude	Other: High altitude

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 Design

Study Type:

Observational

Anticipated Enrollment :

132 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High altitude-a Multicenter, Prospective Cohort Study

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

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

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
DCR [4 years]
Disease control 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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