Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer

The First Affiliated Hospital with Nanjing Medical University100 enrolled

Overview

This is a multicenter, observational, single-arm real world study to evaluate the efficacy and safety of pyrotinib after lapatinib progression.

HER2-positive breast cancers account for 15%-20% of all breast cancers. The development of HER2 targeted therapies have greatly improved the survival of HER2-positive breast cancer patients. Lapatinib has shown effectiveness in treating HER2-positive metastatic breast cancers, but therapies after lapatinib progression are still controversial. This study is aimed to evaluate the efficacy and safety of pyrotinib after lapatinib progression.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Breast Cancer

Interventions

PyrotinibDRUG

Pyrotinib-based therapy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female and 18-70 years old * Metastatic or locally recurrent HER2-positive breast cancer * Patients received pyrotinib-based therapy after lapatinib failure in treatment for metastasis * Complete and accurate medical data Exclusion Criteria: \- Incomplete medical data

Locations (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

Time frame: 2 years

Objective Response Rate (ORR)

The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set

Time frame: 2 years

Secondary Outcomes

The Number of Participants Who Experienced Adverse Events (AE)

Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).

Time frame: 2 years

Data from ClinicalTrials.gov

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