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出境医 / 临床实验 / A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

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

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
Breast Cancer Drug: Pyrotinib Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pyrotinib versus Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2024
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 :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Overall Survival (OS) [ Time Frame: up to 2 years ]
    Overall survival is defined as the time from randomization to death from any cause.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
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China
Fudan University Cancer Hospital
Shanghai, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Study Chair: Zhimin Shao Fudan University
Tracking Information
First Submitted Date  ICMJE June 6, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date May 24, 2021
Actual Study Start Date  ICMJE July 12, 2019
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • 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 invisive cancer, 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pyrotinib versus Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Pyrotinib
    pyrotinib 400 mg, orally once daily for one year
  • Drug: Placebo
    placebo 400mg, orally once daily for one year
Study Arms  ICMJE
  • Experimental: Arm Pyrotinib
    Intervention: Drug: Pyrotinib
    Intervention: Drug: Pyrotinib
  • Placebo Comparator: Arm Placebo
    Intervention: Drug: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 6, 2019) 		1192
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2024
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03980054
Other Study ID Numbers  ICMJE HR-BLTN-III-EBC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhimin Shao Fudan University
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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