A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03980054|
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Pyrotinib Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1192 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Pyrotinib versus Placebo|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab|
|Estimated Study Start Date :||June 15, 2019|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||July 31, 2024|
Experimental: Arm Pyrotinib
Intervention: Drug: Pyrotinib
pyrotinib 400 mg, orally once daily for one year
Placebo Comparator: Arm Placebo
Intervention: Drug: Placebo
placebo 400mg, orally once daily for one year
- Invasive Disease-free Survival (iDFS) [ Time Frame: 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.
- Disease-free Survival (DFS) [ Time Frame: 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) [ Time Frame: up to 2 years ]Overall survival is defined as the time from randomization to death from any cause.
- Distance Disease-free Survival (DDFS) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980054
|Contact: Xiaoyu Zhu, PH.Demail@example.com|
|Contact: Fei Wu, M.Dfirstname.lastname@example.org|
|Study Chair:||Zhimin Shao||Fudan University|