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

NCT05231863 | Unknown FDA Drug

• 1 other identifier: THALIA-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• The Number of Participants Who Experienced Adverse Events (AE)

  2 years

Study Arms (1)

Observational Group

Patients receive TKIs after T-DM1 progression.

Drug: TKIs

Interventions

TKIs DRUG

tyrosine kinase inhibitors based therapy

Observational Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2-positive metastatic breast cancer patients who failed by T-DM1 received TKIs

You may qualify if:

• 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

You may not qualify if:

• \- Incomplete medical data

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yongmei Yin

CONTACT

02568307102; ymyin@njmu.edu.cn

Wei Li

CONTACT

02568307102; real.lw@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 9, 2022
• Study Start: August 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)