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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

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Pyrotinib Maleate combine with Docetaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pyrotinib Maleate combine with Docetaxel
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase II Open Label Study of Pyrotinib Maleate Combined With Docetaxel in the First-line Treatment of HER2-positive Metastatic Breast Cancer
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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.

Drug: Pyrotinib Maleate combine with Docetaxel
Pyrotinib Maleate combine with Docetaxel as the first-line treatment to HER2-positive Metastatic Breast Cancer




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. PFS [ Time Frame: from enrollment to progression or death (for any reason),assessed up to 100 months ]
    Progression-Free Survival

  2. 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

  3. 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

  4. OS [ Time Frame: from enrollment to death (for any reason).assessed up to 100 months ]
    Overall Survival


Other Outcome Measures:
  1. 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



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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:

  • 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.

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): NCT03876587


Contacts
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Contact: Xiaojia Wang, PhD 86 13906500190 wxiaojia0803@163.com
Contact: Jian Huang, chief doctor 86 13588048995 huang_jian22@aliyun.com

Locations
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China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Study Director: Jian Huang, chief doctor Zhejiang Cancer Hospital

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Responsible Party: Xiaojia Wang(xj wang), Director, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03876587     History of Changes
Other Study ID Numbers: HR-BLTN-001
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the data will be shared from the trial begin and for 10 years.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: from the trial begin and for 10 years.
Access Criteria: every one

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaojia Wang(xj wang), Zhejiang Cancer Hospital:
Metastatic Breast Cancer
Pyrotinib Maleate
HER2 Targeted Therapy

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Maleic acid
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors