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

NCT ID: NCT05231863

Last Updated: 2022-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observational Group

Patients receive TKIs after T-DM1 progression.

TKIs

Intervention Type DRUG

tyrosine kinase inhibitors based therapy

Interventions

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TKIs

tyrosine kinase inhibitors based therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongmei Yin

Role: CONTACT

02568307102

Wei Li

Role: CONTACT

02568307102

Facility Contacts

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Jinhai Tang

Role: primary

Other Identifiers

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THALIA-01

Identifier Type: -

Identifier Source: org_study_id

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