A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2

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

Study Overview

• Status: Unknown
• Conditions: HER2 Positive Breast Carcinoma

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Pan Yueyin; Phone Number: 13805695536; Email: yueyinpan1965@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival is defined as the length of time from random assignment to death or to last contact.	1 year
AE	adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.	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	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	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	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	1 year

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 10, 2019
• Primary Completion (Anticipated): April 10, 2020
• Study Completion (Anticipated): October 10, 2020

Study Registration Dates

• First Submitted: April 7, 2019
• First Submitted That Met QC Criteria: April 7, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 7, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Efficacy; HER-2; Pyrotinib Maleate Tablets; Real word study
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: AnhuiPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No