NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Active Not RecruitingPhase 3

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Conditions: Breast Cancer

Interventions: Pyrotinib, Placebo

Countries: China

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Shanghai, China