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

NCT05063643 | Unknown

• 1 other identifier: SL-2020076
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HER2-positive breast cancer; Targeted therapy; Cardiotoxicity; High Altitude

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• pCR rate

  4 years

• ORR

  4 years

• DCR

  4 years

• OS

  5 years

• the incidence of treatment-related adverse events

  5 years

Interventions

High altitude OTHER

High altitude is defined as \>2000m.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All enrolled patients are from four centers of Qinghai province.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead

Study Sites (1)

Affiliated Hospital of Qinghai University

Xining, Qinghai, 810000, China

Location

MeSH Terms

Conditions

Cardiotoxicity; Altitude Sickness

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: October 1, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

CN (1)