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Pyrotinib Combined With Docetaxel in the First-line Treatment of HER2-positive MBC

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ClinicalTrials.gov Identifier: NCT03876587
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Xiaojia Wang(xj wang), Zhejiang Cancer Hospital

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date March 15, 2019
Estimated Study Start Date  ICMJE March 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
Objective Response Rate [ Time Frame: from enrollment to progression or death (for any reason), assessed up to 100 months ]
Ratio of CR and PR in all subjects
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • PFS [ Time Frame: from enrollment to progression or death (for any reason),assessed up to 100 months ]
    Progression-Free Survival
  • DoR [ Time Frame: The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months ]
    Duration of Response
  • Clinical Benefit Rate [ Time Frame: from enrollment to progression or death (for any reason),assessed up to 100 months ]
    Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects
  • OS [ Time Frame: from enrollment to death (for any reason).assessed up to 100 months ]
    Overall Survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2019)
adverse event [ Time Frame: from enrollment to 30 days after the last dose administrate ]
Adverse events are described in terms of CTC AE 5.0
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Pyrotinib Combined With Docetaxel in the First-line Treatment of HER2-positive MBC
Official Title  ICMJE A Multicenter, Phase II Open Label Study of Pyrotinib Maleate Combined With Docetaxel in the First-line Treatment of HER2-positive Metastatic Breast Cancer
Brief Summary To explore the efficacy and safety of pyrotinib combined with docetaxel regimen in the first-line treatment of HER2-positive metastatic breast cancer.
Detailed Description A multi-center, one-arm, open label design study,which is planned to enroll 79 patients with HER2-positive metastatic breast cancer receiving first-line treatment with pyrotinib and docetaxel. The main purpose of this study was to observe the efficacy and safety of first-line treatment with pyrrolidine and docetaxel for HER2-positive metastatic breast cancer.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Pyrotinib Maleate combine with Docetaxel
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE Drug: Pyrotinib Maleate combine with Docetaxel
Pyrotinib Maleate combine with Docetaxel as the first-line treatment to HER2-positive Metastatic Breast Cancer
Study Arms  ICMJE Experimental: Pyrotinib Maleate combine with Docetaxel

Pyrotinib Maleate combine with Docetaxel should be administrate to all subjects.

Initial dose: Pyrotinib Maleate 400mg oral administration everyday plus Docetaxel 75mg per square of BSA every three weeks intravenous injection.

Intervention: Drug: Pyrotinib Maleate combine with Docetaxel
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
79
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
  • HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
  • do not chemotherapy for recurrent and metastatic lesions, but local treatment for local symptoms, such as radiotherapy for relieving bone pain, is allowed.
  • if the patient is bilateral breast cancer, metastasis lesions must be HER2-positive.
  • 18-70 years old.
  • ECOG PS 0~1.
  • life expectancy is not less than 12 weeks.
  • at least one measurable lesion according to RECIST 1.1.
  • Endocrine therapy is allowed to relapse/metastasis disease; patients with previous adjuvant/neoadjuvant use of Taxus and trastuzumab, disease-free interval from the end of last adjuvant/neoadjuvant Taxus therapy to the progression of tumors (≥12 months), and disease-free interval from the end of last adjuvant/neoadjuvant trastuzumab to the progression of tumors (≥ 6 months).
  • ANC ≥ 1.5×109/L,PLT ≥ 75×109/L,Hb ≥ 100 g/L;TBIL≤1.0ULN;ALT and AST≤3×ULN(ALT and AST≤5×ULN if liver metastasis);BUN and Cr≤1.5×ULN and CCr≥50 mL/min.
  • LVEF ≥ 50% and QTc≤480 ms.
  • known hormone receptor status.
  • Signed informed

Exclusion Criteria:

  • Central nervous system metastasis.
  • Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
  • patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period
  • Participated in other drug clinical trials within 4 weeks before admission
  • Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past.
  • Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
  • Receive other antitumour treatment at the same time
  • A history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
  • Has suffered from any heart disease
  • Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
  • According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
  • The patient did not recover from the toxicity of previous treatment to grade 0-1 (except hair loss).
  • History of neurological or psychiatric disorders
  • Along with CYP3A4 inhibitors or inducers or drugs that are using to prolong the QT interval
  • Researchers believe that patients are not suitable for any other situation in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaojia Wang, PhD 86 13906500190 wxiaojia0803@163.com
Contact: Jian Huang, chief doctor 86 13588048995 huang_jian22@aliyun.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03876587
Other Study ID Numbers  ICMJE HR-BLTN-001
Has Data Monitoring Committee No
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: Yes
Plan Description: the data will be shared from the trial begin and for 10 years.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: from the trial begin and for 10 years.
Access Criteria: every one
Responsible Party Xiaojia Wang(xj wang), Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Investigators  ICMJE
Study Director: Jian Huang, chief doctor Zhejiang Cancer Hospital
PRS Account Zhejiang Cancer Hospital
Verification Date March 2019

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