HER2-positive Breast CancerNCT05063643
Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude
An observational study of HER2-positive Breast Cancer and Targeted Therapy, run by Affiliated Hospital of Qinghai University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer, Targeted Therapy, Cardiac Toxicity
- What is being tested?
- High altitude
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All enrolled patients are from four centers of Qinghai province.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- High altitude
- Keywords
- HER2-positive breast cancer, Targeted therapy, Cardiotoxicity, High Altitude
- Medical subject headings
- Cardiotoxicity, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High altitudeOther
High altitude is defined as >2000m.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (5)
pCR rate
Pathologic complete response (pCR) rate in patients received neoadjuvant therapy
Measured: 4 years
ORR
Objective remission rate in patients received neoadjuvant and palliative therapy
Measured: 4 years
DCR
Disease control rate in patients received neoadjuvant and palliative therapy
Measured: 4 years
OS
Overall survival of the enrolled patients
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063643
- Sponsor's protocol ID
- SL-2020076
- Status last verified
- Sep 2021
- First submitted
- 26 Jul 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High altitude-a Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05063643
- Acronym / sponsor ID
- SL-2020076
- Keywords
- HER2-positive breast cancer, Targeted therapy, Cardiotoxicity, High Altitude
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All enrolled patients are from four centers of Qinghai province.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High altitudeHigh altitude is defined as >2000m. | Other | – |
Primary outcome
Incidence rate of cardiotoxicity
Time frame: 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.
5 secondary outcomes
pCR rate
Time frame: 4 years
ORR
Time frame: 4 years
DCR
Time frame: 4 years
OS
Time frame: 5 years
the incidence of treatment-related adverse events
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer and Targeted Therapy, run by Affiliated Hospital of Qinghai University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of cardiotoxicity (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.