Clinical trial NCT03908749: A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2
Official title: A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HER2 Positive Breast Carcinoma
Keywords: Pyrotinib Maleate Tablets
HER-2
Real word study
Efficacy
Safety
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2019-04-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PFS
timeFrame: 1 year
measure: pCR
timeFrame: 1 year
Secondary outcomes:
measure: OS
timeFrame: 1 year
measure: AE
timeFrame: 1 year
measure: ORR
timeFrame: 1 year
measure: DCR
timeFrame: 1 year
measure: DFS
timeFrame: 1 year
measure: DDFS
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: