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

HER2-positive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05063643
• Other study ID #: SL-2020076
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Altitude Sickness
• Breast Neoplasms
• Cardiac Toxicity
• Cardiotoxicity
• HER2-positive Breast Cancer
• High Altitude
• Targeted Therapy

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