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

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Pyrotinib

• Registration Number: NCT05880927
• Lead Sponsor: Taizhou Hospital

Brief 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.

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 Timeline

• Study Start: 2019-01-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-26
• Last Update Submitted: 2023-05-26
• Study First Posted: 2023-05-30
• Last Update Posted: 2023-05-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pyrotinib 400mg/day	Pyrotinib	High risk HER2 positive patients receive pyrotinib 400mg/day for half or one year

Primary Outcome Measures

Name	Time	Method
iDFS	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taizhou Hospital; 🇨🇳 Taizhou, Zhejiang, China