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Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04605575
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
wang shusen, Sun Yat-sen University

Brief Summary:

The purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer.

The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of pyrotinib and vinorelbine in patients with advanced solid tumors. In the second part of the study, we will explore the safety and efficacy of Pyrotinib + vinorelbine in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination.


Condition or disease Intervention/treatment Phase
Breast Cancer Pyrotinib Breast Diseases Vinorelbine HER2-positive Breast Cancer Drug: Pyrotinib 320mg + Vinorelbine Drug: Pyrotinib 400mg + Vinorelbine Drug: Pyrotinib plus Vinorelbine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Multi-center Phase II Clinical Study of Pyrotinib Combined With Vinorelbine in the Treatment of HER2-positive and Treated Metastatic Breast Cancer
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Pyrotinib plus vinorelbine Drug: Pyrotinib 320mg + Vinorelbine
pyrotinib 320mg tablets administered daily by mouth, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle. Treatment lasts for two cycles

Drug: Pyrotinib 400mg + Vinorelbine
pyrotinib 400mg tablets administered daily by mouth, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle. Treatment lasts for two cycles

Drug: Pyrotinib plus Vinorelbine
pyrotinib administered daily by mouth(MTD), vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle, or vinorelbine(iv) 25 mg/m2 on day 1 and day 8 of 21 day cycle. Treatments will lasts until disease progression (as assessed by the investigator) or unmanageable toxicity.




Primary Outcome Measures :
  1. PFS as Assessed by the Investigator [ Time Frame: from enrollment to progression or death (for any reason), assessed up to 3 years ]
    Progression-Free Survival


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Ratio of CR and PR in all subjects ]
    from enrollment to progression or death (for any reason), assessed up to 3 years

  2. OS [ Time Frame: from enrollment to progression or death (for any reason), assessed up to 3 years ]
    OS was defined as the time from the date of randomization to the date of death from any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed invasive breast cancer
  • HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results
  • Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent. Patients who have previously used pertuzumab will be allowed.
  • Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator
  • Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded
  • Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • History of treatment with pyrotinib
  • Prior treatment with lapatinib or neratinib
  • History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma
  • History of receiving any anti-cancer drug/biologic or investigational treatment within 28 days prior to randomization except hormone therapy
  • Recovery of treatment-related toxicity consistent with other eligibility criteria
  • History of radiation therapy within 28 days of randomization
  • Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization
  • History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
  • History of myocardial infarction or unstable angina
  • Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)
  • Pregnancy or lactation
  • Current known active infection with human immunodeficiency virus (HIV) or hepatitis C virus
  • Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis

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): NCT04605575


Contacts
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Contact: wang shusen +86-13926168469 wangshs@sysucc.org.cn
Contact: zhang jingmin +8618826246924 zhangjm1@sysucc.org.cn

Locations
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China
Zhang Jingmin Recruiting
Guangzhou, China
Contact: zhang jingmin    +8618826246924    zhangjm1@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Publications:
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Responsible Party: wang shusen, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04605575    
Other Study ID Numbers: MA-BC-II-002
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
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
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases
Vinorelbine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action