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

HER2 Positive Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03908749
• Other study ID #: AnhuiPH
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2 Positive Breast Carcinoma

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