A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm Pyrotinib Intervention: Drug: Pyrotinib |
Drug: Pyrotinib
pyrotinib 400 mg, orally once daily for one year
|
| Placebo Comparator: Arm Placebo Intervention: Drug: Placebo |
Drug: Placebo
placebo 400mg, orally once daily for one year
|
Outcome Measures
Primary Outcome Measures
- Invasive Disease-free Survival (iDFS) [From randomization until time of event up to 2 years]
Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
Secondary Outcome Measures
- Disease-free Survival (DFS) [From randomization until time of event up to 2 years]
Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ(DCIS),or distant recurrence and death from any cause.
- Overall Survival (OS) [up to 2 years]
Overall survival is defined as the time from randomization to death from any cause.
- Distance Disease-free Survival (DDFS) [distant recurrence From randomization until time of event up to 2 years]
Distance Disease-free Survival is defined as the time from date of randomization until the first distant recurrence and death from any cause.
Eligibility Criteria
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.
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Known hormone receptor status.
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Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by Echocardiogram.
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Been treated for early breast cancer with standard of care duration of trastuzumab.
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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.
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History of heart disease.
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Bilateral breast cancer.
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Corrected QT (QTc) interval ≥0.47 seconds.
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History of gastrointestinal disease with diarrhea as the major symptom.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Cancer Hospital | Shanghai | China |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
- Study Chair: Zhimin Shao, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HR-BLTN-III-EBC