Pyrotinib in Women With High-risk in Early Stage Breast Cancer

Phase 2RecruitingNCT05834764

The First Affiliated Hospital with Nanjing Medical University188 enrolled

Overview

ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached. However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

188

Conditions

HER2-positive Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects voluntarily participate in this study and sign the informed consent form； 2. Female or male patients, aged ≥ 18 years, and ≤75 years; 3. ECOG PS score: 0-1; 4. Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH). 5. Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery. 6. Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1. 7. Could have been treated neoadjuvantly but have not reached pathologic complete response. Exclusion Criteria: 1. metastatic disease (Stage IV) or inflammatory breast cancer 2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix. 3. Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. A history of allergy to the drugs in this study； 5. Unable or unwilling to swallow tablets 6. History of gastrointestinal disease with diarrhea as the major symptom.

Outcomes

Primary Outcomes

Invasive Disease-free Survival (iDFS) at year 2

Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.

Time frame: From enrollment until time of events up to 2 years

Secondary Outcomes

Disease-free Survival at year 2 (2y-DFS)

Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.

Time frame: From enrollment until time of events up to 2 years

Overall Survival (OS)

Randomization to death from any cause

Time frame: Enrollment until death due to any cause, up to 10 years

Invasive Disease-free Survival (iDFS) at year 5

Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.

Time frame: From enrollment until time of events up to 5 years

AEs and SAEs

Adverse events and Adverse events and serious adverse events according to CACTE 5.0

Time frame: From the first administration to one months after the last drug administration