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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pyrotinib 400mg/day

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

Group Type EXPERIMENTAL

Pyrotinib

Intervention Type DRUG

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

Interventions

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Pyrotinib

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No