Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer

May 26, 2023 updated by: Haihua Yang, Taizhou Hospital

Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer: an Open-label, Multi-center Trial

This trial is a multicenter, open-label, phase II trial conducted at 23 centers in China. High-risk HER2 positive patients receive pyrotinib 400mg/day for one year or half year for extented adjuvant therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients must meet one of the following criteria: N stage ≥1; T stage ≥2; did not achieve pathological complete response (pCR) after neoadjuvant therapy; had pCR after neoadjuvant therapy but with tumor size ≥ 5cm or N stage ≥2; or tumor size less than 2cm but with high Ki67; histologic grade 3 or with lymph node micrometastasis.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Feilin Cao, Master
  • Phone Number: 13806562998
  • Email: drcfl@126.com

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women aged 18-75 years old
  2. HER2 positive breast cancer
  3. ECOG PS 0-1
  4. Known hormone receptor status
  5. Completed 1 year of trastuzumab-based adjuvant therapy within 6 months
  6. Patients at high risk

Exclusion Criteria:

  1. Serious heart disease or discomfort
  2. Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption
  3. Known allergic history of drug components of this regimen
  4. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation
  5. Pregnant and lactating female patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pyrotinib 400mg/day
High risk HER2 positive patients receive pyrotinib 400mg/day for half or one year
Drug: Pyrotinib
Patients receive pyrotinib 400mg/day for half or one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iDFS
Time Frame: From date of receiving drug until the date of first documented invasive disease or date of death from any cause, whichever came first, assessed up to 60 months
INVASIVE DISEASE FREE SURVIVAL
From date of receiving drug until the date of first documented invasive disease or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From date of receiving drug until the date of death from any cause, assessed up to 60 months
Overall Survival
From date of receiving drug until the date of death from any cause, assessed up to 60 months
Adverse events
Time Frame: through study completion, an average of 5 years
frequency of adverse events
through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taizhou Hospital

Investigators

  • Principal Investigator: Feilin Cao, Master, Taizhou Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERSIST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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