HER2-positive Breast CancerNCT04158505
Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer
An observational study of HER2-positive Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This Non-Interventional Study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of HER2 positive breast cancer in the real world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- non-interventional
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2020to 15 Nov 2023
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HER2+ breast cancer patients whose treatment decision with pyrotinib has been made by their physician and who meet the eligibility criteria will be invited to participate in the study
Who may be able to join
- ≥18 years old with histologically confirmed HER2 positive breast cancer.
- Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive.
- Physician has determined that treatment with pyrotinib is indicated.
- Traceable medical record available.
Who cannot join
- Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent .
- Pregnant or breast feeding patients
- Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment.
- Patients not suitable for this study under investigators' consideration.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Xu Binghe, M.D., 86-10-88788826, xubinghe@medmail.com.cn
About this study
Official title: Real World Study on the Efficacy and Safety of Pyrotinib in the Treatment of HER2 Positive Breast Cancer: An Observational,Multi-center,Prospective Study (Real Pretty Study)
This Non-Interventional Study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of HER2 positive breast cancer in the real world.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- non-interventional
- Keywords
- pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionalOther
This prospective, observational study will be conducted according to each site's routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| non-interventional study | Not described Receives: Other: non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival(PFS)
Progression Free Survival(PFS)
Measured: 12 months
Pathological Complete Response（pCR）Rate
Percentage of Participants With Pathological Complete Response
Measured: through study completion, an average of 1 year
Incidences of adverse events and toxicities
Incidences of adverse events and toxicities
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start28 Feb 2020
- Primary completion15 Nov 2021 (estimated)
- Study completion15 Nov 2023 (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
- 3,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binghe Xu, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158505
- Sponsor's protocol ID
- HR-BLTN-016
- Status last verified
- Apr 2020
- First submitted
- 7 Nov 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study on the Efficacy and Safety of Pyrotinib in the Treatment of HER2 Positive Breast Cancer: An Observational,Multi-center,Prospective Study (Real Pretty Study)
- ClinicalTrials.gov ID
- NCT04158505
- Acronym / sponsor ID
- HR-BLTN-016
- Conditions
- HER2-positive Breast Cancer
- Keywords
- pyrotinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 8 Nov 2019 (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 Non-Interventional Study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of HER2 positive breast cancer in the real world.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-interventional study | – | Other: non-interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2+ breast cancer patients whose treatment decision with pyrotinib has been made by their physician and who meet the eligibility criteria will be invited to participate in the study
Key inclusion criteria (4 listed)
- ≥18 years old with histologically confirmed HER2 positive breast cancer.
- Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive.
- Physician has determined that treatment with pyrotinib is indicated.
- Traceable medical record available.
Key exclusion criteria (4 listed)
- Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent .
- Pregnant or breast feeding patients
- Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment.
- Patients not suitable for this study under investigators' consideration.
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 |
|---|---|---|
| non-interventionalThis prospective, observational study will be conducted according to each site's routine clinical practice | Other | non-interventional study |
Primary outcome
Progression Free Survival(PFS)
Time frame: 12 months
Progression Free Survival(PFS)
Pathological Complete Response（pCR）Rate
Time frame: through study completion, an average of 1 year
Percentage of Participants With Pathological Complete Response
Incidences of adverse events and toxicities
Time frame: through study completion, an average of 1 year
Incidences of adverse events and toxicities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
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, run by Chinese Academy of Medical Sciences 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 4 inclusion and 4 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 24 Apr 2020. 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?
Contact Xu Binghe (+86-10-87788120, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival(PFS) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 24 Apr 2020.