A Real-world Efficacy and Safety Study of Amlotinib for HER2-negative Advanced Breast Cancer

NCT06340165 | Recruiting

• 1 other identifier: 2023-KS-151
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

This study analyses the efficacy and safety of amlotinib as a study drug in the treatment of HER-2 negative advanced breast cancer in the real world, including the number of treatment lines, monotherapy, combination therapy, and different molecular subtypes of breast cancer. Evidence-based medicine evidence for clinicians. Although the clinical application of amlotinib in breast cancer treatment is a supra-indication drug, in view of its high safety and possible good efficacy for advanced breast cancer, some patients have been clinically adopted to try the treatment after communicating with their families. This study provides evidence for the further use of amlotinib in breast cancer treatment by analysing the efficacy and safety of amlotinib in real-world applications.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-FreeSurvival

  Incorporation January 2021 through November 2023

Interventions

Anlotinib DRUG

Anrotinib is available in 12 mg, 10 mg, and 8 mg doses. The recommended dose of Anrotinib is 12 mg taken by mouth once daily, continuously, for 2 weeks on and 1 week off, in a 21-day cycle.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective cohort study to collect clinical data of patients with HER-2 negative advanced breast cancer treated with amrutinib at four centers four centers at the First Hospital of Jilin University, Liaoning Provincial Cancer Hospital, Shandong Provincial Cancer Hospital, and Peking University Cancer Hospital between 2019.1 and 2022.9

You may qualify if:

• Imaging or tissue/cell puncture, etc. confirmed recurrent, metastatic breast cancer
• Pathologically confirmed HER-2 negative
• Application of amlotinib treatment until disease progression or toxicity intolerable, or voluntarily give up the continuation of amlotinib treatment,amlotinib application for at least 2 cycles
• The clinical data are basically complete

You may not qualify if:

• Patients receiving local treatment means such as surgery and radiotherapy
• Patients with combined second primary breast cancer and other primary malignant tumors
• Patients with symptomatic brain metastases

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Affiliated Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jiuwei Cui

CONTACT

15843073215; jdyycjw@163.com

Zheng Lv

CONTACT

15804301705; lvz@jlu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: April 1, 2024
• Study Start: February 4, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-02

Locations

CN (1)