A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage 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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2024-07-31

Brief Summary

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This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pyrotinib versus Placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm Pyrotinib

Intervention: Drug: Pyrotinib

Group Type EXPERIMENTAL

Pyrotinib

Intervention Type DRUG

pyrotinib 400 mg, orally once daily for one year

Arm Placebo

Intervention: Drug: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo 400mg, orally once daily for one year

Interventions

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Pyrotinib

pyrotinib 400 mg, orally once daily for one year

Intervention Type DRUG

Placebo

placebo 400mg, orally once daily for one year

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female patients, 18 years ≤ age ≤ 75 years；
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
* Histologically confirmed invasive HER2 positive breast cancer.
* Known hormone receptor status.
* Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by Echocardiogram.
* Been treated for early breast cancer with standard of care duration of trastuzumab.
* If been not treated neoadjuvantly, lymph node metastases need to be confirmed by postoperative pathology; if been treated neoadjuvantly , have not reached totally pathologic complete response.
* Signed informed consent form (ICF) .

Exclusion Criteria

* Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
* History of heart disease.
* Bilateral breast cancer.
* Corrected QT (QTc) interval ≥0.47 seconds.
* History of gastrointestinal disease with diarrhea as the major symptom.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No