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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03908749
Other study ID # AnhuiPH
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 10, 2019
Est. completion date October 10, 2020

Study information

Verified date April 2019
Source Anhui Provincial Hospital
Contact Pan Yueyin
Phone 13805695536
Email yueyinpan1965@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the efficacy and safety of Pyrotinib Maleate Tablets in the treatment of advanced breast cancer patients with positive her-2.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date October 10, 2020
Est. primary completion date April 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female patients .

2. Confirmed by pathological examination of breast cancer patients with positive her-2 expression

3. 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.

4. Patients should be voluntary to the trial and provide with signed informed consent

5. The researchers believe patients can benefit from the study.

Exclusion Criteria:

1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to Pyrotinib maleate tablets or its accessories

2. Pregnant or lactating women

3. Patients with Pyrotinib maleate tablets contraindications

4. Patients of doctors considered unsuitable for the trial

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Anhui Provincial Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
Primary pCR Pathological complete response is the breast primary focus and axillary lymph node surgery specimen pathological examination without invasive tumor cell residual 1 year
Secondary OS overall survival is defined as the length of time from random assignment to death or to last contact. 1 year
Secondary AE adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. 1 year
Secondary 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 1 year
Secondary 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 1 year
Secondary DFS Disease-free survival (DFS) is defined as the time from the beginning of randomization to recurrence or death due to Disease progression 1 year
Secondary 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 1 year
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