Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiac Toxicity | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| High Altitude | — | UNRESOLVED | — |
| Targeted Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High altitude | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence rate of cardiotoxicity
- timeFrame
- 5 years
- description
- 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 outcomes (5)
- measure
- pCR rate
- timeFrame
- 4 years
- description
- Pathologic complete response (pCR) rate in patients received neoadjuvant therapy
- measure
- ORR
- timeFrame
- 4 years
- description
- Objective remission rate in patients received neoadjuvant and palliative therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available