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

Breast Cancer Clinical Trial

Official title:

Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer: A Real World Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04899128
• Other study ID #: POLAR-01
• Status: Active, not recruiting
• Start date: August 1, 2018
• Est. completion date: June 2021

Study information

• Verified date: May 2021
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pyrotinib
Pyrotinib-based therapy

Locations

Country	Name	City	State
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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	2 years
Secondary	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).	2 years