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

Taizhou Hospital150 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Breast Cancer

Interventions

PyrotinibDRUG

Patients receive pyrotinib 400mg/day for half or one year

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Taizhou Hospital

Taizhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

iDFS

INVASIVE DISEASE FREE SURVIVAL

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

Secondary Outcomes

Overall Survival

Time frame: From date of receiving drug until the date of death from any cause, assessed up to 60 months

Adverse events

frequency of adverse events

Time frame: through study completion, an average of 5 years

Central Contacts

Feilin Cao, Master

CONTACT

13806562998 drcfl@126.com

Zhiqiang Xiao, Master

CONTACT

17757194561 zhiqiang.xiao@hengrui.com

Data from ClinicalTrials.gov

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