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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
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

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




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.



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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.

Information from the National Library of Medicine

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


Contacts
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Contact: Xiaoyu Zhu, PH.D +86-13774383638 zhuxiaoyu@hrglobe.cn
Contact: Fei Wu, M.D +86-15201658815 wufei@hrglobe.cn

Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Study Chair: Zhimin Shao Fudan University

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03980054     History of Changes
Other Study ID Numbers: HR-BLTN-III-EBC
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents