HER2 Positive Breast CarcinomaNCT03908749
A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2
An observational study of HER2 Positive Breast Carcinoma, run by Anhui Provincial Hospital.
Trial summary
To evaluate the efficacy and safety of Pyrotinib Maleate Tablets in the treatment of advanced breast cancer patients with positive her-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 Positive Breast Carcinoma
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2019to 10 Oct 2020
- 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: Patients with locally advanced her-2 positive breast cancer who are not treated with standard neoadjuvant regimens or who are not treated with standard neoadjuvant regimens.
Who may be able to join
- Male or female patients .
- Confirmed by pathological examination of breast cancer patients with positive her-2 expression
- The researchers determined that the standard neoadjuvant regimen was ineffective in the treatment of patients with locally advanced her-2 positive breast cancer or that the standard neoadjuvant regimen was not applicable.
- Patients should be voluntary to the trial and provide with signed informed consent
- The researchers believe patients can benefit from the study.
Who cannot join
- Patients with a known history of allergic reactions and/or hypersensitivity attributed to Pyrotinib maleate tablets or its accessories
- Pregnant or lactating women
- Patients with Pyrotinib maleate tablets contraindications
- Patients of doctors considered unsuitable for the trial
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the efficacy and safety of Pyrotinib Maleate Tablets in the treatment of advanced breast cancer patients with positive her-2.
Read the detailed description
This study intends to carry out multicenter, observational cohort clinical research, using maleic acid pyrrole for his piece of HER-2 positive treatment of advanced breast cancer treatment, observation and verification maleic acid pyrrole for his piece for a line or a single drug resistance by bead in the real diagnosis and treatment in patients with advanced breast cancer environment and the efficacy and safety of new treatments. Biomarkers of breast cancer prognosis are of great significance in predicting the degree of malignancy, metastasis and recurrence of breast cancer, as well as guiding clinical treatment programs.This study will explore the prognostic factors and curative effect of breast cancer patients from multiple aspects, explore the dominant population of breast cancer patients with pyrrolidone maleate, and provide the theoretical basis for individualized treatment for clinical treatment practice.
- Conditions
- HER2 Positive Breast Carcinoma
- Keywords
- Pyrotinib Maleate Tablets, HER-2, Real word study, Efficacy, Safety
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
Measured: 1 year
pCR
Pathological complete response is the breast primary focus and axillary lymph node surgery specimen pathological examination without invasive tumor cell residual
Measured: 1 year
Secondary outcomes (6)
OS
overall survival is defined as the length of time from random assignment to death or to last contact.
Measured: 1 year
AE
adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Measured: 1 year
ORR
Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments
Measured: 1 year
DCR
Disease control rate (DCR) refers to the percentage of cases with remission and disease stability after treatment in the total number of evaluable cases
Measured: 1 year
DFS
Disease-free survival (DFS) is defined as the time from the beginning of randomization to recurrence or death due to Disease progression
Measured: 1 year
DDFS
Disease /recurrence free survival (DDFS) refers to a period of time after treatment for a tumor patient where no metastatic lesions were found anywhere else in the body except for the accident of the primary lesion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start10 Apr 2019 (estimated)
- Primary completion10 Apr 2020 (estimated)
- Study completion10 Oct 2020 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yue-Yin Pan, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908749
- Sponsor's protocol ID
- AnhuiPH
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2019
- Last updated
- 9 Apr 2019
- 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 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2
- ClinicalTrials.gov ID
- NCT03908749
- Acronym / sponsor ID
- AnhuiPH
- Conditions
- HER2 Positive Breast Carcinoma
- Keywords
- Pyrotinib Maleate Tablets, HER-2, Real word study, Efficacy, Safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 10 Apr 2019 (estimated)
- Primary completion
- 10 Apr 2020 (estimated)
- Study completion
- 10 Oct 2020 (estimated)
- First posted
- 9 Apr 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.
To evaluate the efficacy and safety of Pyrotinib Maleate Tablets in the treatment of advanced breast cancer patients with positive her-2.
Detailed description
This study intends to carry out multicenter, observational cohort clinical research, using maleic acid pyrrole for his piece of HER-2 positive treatment of advanced breast cancer treatment, observation and verification maleic acid pyrrole for his piece for a line or a single drug resistance by bead in the real diagnosis and treatment in patients with advanced breast cancer environment and the efficacy and safety of new treatments. Biomarkers of breast cancer prognosis are of great significance in predicting the degree of malignancy, metastasis and recurrence of breast cancer, as well as guiding clinical treatment programs.This study will explore the prognostic factors and curative effect of breast cancer patients from multiple aspects, explore the dominant population of breast cancer patients with pyrrolidone maleate, and provide the theoretical basis for individualized treatment for clinical treatment practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced her-2 positive breast cancer who are not treated with standard neoadjuvant regimens or who are not treated with standard neoadjuvant regimens.
Key inclusion criteria (5 listed)
- Male or female patients .
- Confirmed by pathological examination of breast cancer patients with positive her-2 expression
- The researchers determined that the standard neoadjuvant regimen was ineffective in the treatment of patients with locally advanced her-2 positive breast cancer or that the standard neoadjuvant regimen was not applicable.
- Patients should be voluntary to the trial and provide with signed informed consent
- The researchers believe patients can benefit from the study.
Key exclusion criteria (4 listed)
- Patients with a known history of allergic reactions and/or hypersensitivity attributed to Pyrotinib maleate tablets or its accessories
- Pregnant or lactating women
- Patients with Pyrotinib maleate tablets contraindications
- Patients of doctors considered unsuitable for the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS
Time frame: 1 year
Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
pCR
Time frame: 1 year
Pathological complete response is the breast primary focus and axillary lymph node surgery specimen pathological examination without invasive tumor cell residual
6 secondary outcomes
OS
Time frame: 1 year
AE
Time frame: 1 year
ORR
Time frame: 1 year
DCR
Time frame: 1 year
DFS
Time frame: 1 year
DDFS
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for HER2 Positive Breast Carcinoma
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingObservational study
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
HR+/HER2- Early Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
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.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2 Positive Breast Carcinoma, run by Anhui Provincial Hospital.
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 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 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Pan Yueyin (13805695536, yueyinpan1965@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 1 year). The study lists 2 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 9 Apr 2019.