Tyrosine Kinase Inhibitors (TKIs) in Trastuzumab Emtansine (T-DM1) Resistant HER2-positive Metastatic Breast Cancer: A Real-world Study

• Conditions: Breast Cancer
• Interventions: Drug: TKIs

• Registration Number: NCT05231863
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

This is a real world study to evaluate the efficacy and safety of tyrosine kinase inhibitors after T-DM1 progression.

Detailed 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. Trastuzumab emtansine (T-DM1) has shown great effectiveness in treating HER2-positive metastatic breast cancer, but therapies subsequent to T-DM1 progression are still controversial. Here, we investigated efficacy and safety of tyrosine kinase inhibitors (TKIs) based therapy in T-DM1 resistant HER2-positive metastatic breast cancer.

Study Timeline

• Study Start: 2019-08-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-09
• Last Update Posted: 2022-02-09
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Female and 18-70 years old
• Metastatic or locally recurrent HER2-positive breast cancer
• Patients received TKIs-based therapy after T-DM1 failure in treatment for metastasis
• Complete and accurate medical data

Exclusion Criteria

• Incomplete medical data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Group	TKIs	Patients receive TKIs after T-DM1 progression.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	2 years	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.
Objective Response Rate (ORR)	2 years	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

Secondary Outcome Measures

Name	Time	Method
The Number of Participants Who Experienced Adverse Events (AE)	2 years	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).

Trial Locations

Locations (1)

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China