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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HER2-positive Breast Cancer; Targeted Therapy; Cardiac Toxicity; High Altitude
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 132

Contacts and Locations

Study Locations

• China
  • Qinghai
    • Xining, Qinghai, China, 810000
      • Affiliated Hospital of Qinghai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All enrolled patients are from four centers of Qinghai province.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR rate	Pathologic complete response (pCR) rate in patients received neoadjuvant therapy	4 years
ORR	Objective remission rate in patients received neoadjuvant and palliative therapy	4 years
DCR	Disease control rate in patients received neoadjuvant and palliative therapy	4 years
OS	Overall survival of the enrolled patients	5 years
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

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Qinghai University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Targeted therapy; HER2-positive breast cancer; Cardiotoxicity; High Altitude
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Skin Diseases; Respiratory Tract Diseases; Neoplasms; Respiration Disorders; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Breast Neoplasms; Altitude Sickness; Cardiotoxicity
• Other Study ID Numbers: SL-2020076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No