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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880927
• Other study ID #: PERSIST
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Taizhou Hospital
• Contact: Feilin Cao, Master
• Phone: 13806562998
• Email: drcfl[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pyrotinib
Patients receive pyrotinib 400mg/day for half or one year

Locations

Country	Name	City	State
China	Taizhou Hospital	Taizhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Taizhou Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iDFS	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	OS	Overall Survival	From date of receiving drug until the date of death from any cause, assessed up to 60 months
Secondary	Adverse events	frequency of adverse events	through study completion, an average of 5 years