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

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04899128
Collaborator
(none)
100
1
34
2.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer: A Real World Study
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Observational Group

Patients receive pyrotinib-based therapy after lapatinib progression.

Drug: Pyrotinib
Pyrotinib-based therapy

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jiangsu Provincial People's Hospital Nanjing Jiangsu China

Sponsors and Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT04899128
Other Study ID Numbers:
  • POLAR-01
First Posted:
May 24, 2021
Last Update Posted:
May 24, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2021