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Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin® in HER2-Positive, Locally Recurrent or Previously Untreated Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT03084237
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Brief Summary:
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: HLX02 Biological: Herceptin® Drug: docetaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 608 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin® in HER2-Positive, Locally Recurrent or Previously Untreated Metastatic Breast Cancer
Actual Study Start Date : November 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: HLX02+docetaxel Biological: HLX02
8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles.

Drug: docetaxel
75 mg/m2 will be administered on Day 2, Cycle 1.then be given every 3 weeks on Day 1 of each subsequent cycle

Active Comparator: Herceptin®+docetaxel Biological: Herceptin®
8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles

Drug: docetaxel
75 mg/m2 will be administered on Day 2, Cycle 1.then be given every 3 weeks on Day 1 of each subsequent cycle




Primary Outcome Measures :
  1. ORR 24 weeks [ Time Frame: From time of First treatment to week 24 ]
    calculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1.


Secondary Outcome Measures :
  1. PFS up to 12 months [ Time Frame: From time of first treatment to 12 months ]
  2. Overall survival at 12, 24, and 36 months [ Time Frame: From time of first treatment to 36 months ]


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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female ≥18 years of age on day of signing the informed consent form (ICF)
  • Histologically or cytologically confirmed adenocarcinoma of the breast
  • Locally recurrent disease not amenable to curative surgery or radiation therapy, or metastatic disease with an indication for a taxane-containing therapy
  • Availability of formalin-fixed paraffin-embedded tissue block from the primary tumor, or a metastatic lesion, to confirm HER2-positivity by the central laboratory, based on FISH amplification ratio ≥2.0 or IHC score 3+, and for hormone status (ER/PgR) determination (local or central laboratory). If not possible, a fresh biopsy is required
  • No prior systemic chemotherapy, biological or targeted agent for recurrent or metastatic disease. Prior neo-/adjuvant hormone therapy must be stopped at least 4 weeks before randomization. Use of herbal remedies or traditional Chinese medicines for anticancer, hematologic or liver function, or anti-infective treatment must be stopped at least 2 weeks before randomization or at time of the ICF signature at the latest
  • Prior neo-/adjuvant therapy containing trastuzumab and/or lapatinib (excluding other HER2-targeting agents) must have been stopped at least 12 months before the ICF signature. If trastuzumab was not used, prior neo-/adjuvant therapy with a taxane must have been stopped at least 6 months before the ICF signature. Prior neo-/adjuvant therapy with other cytotoxics and/or hormone therapy must have been stopped at least 4 weeks before the ICF signature
  • Measurable disease (at least one measurable target lesion assessed by CIR; bone-only or central nervous system [CNS]-only metastases are not allowed)
  • Eastern Cooperative Oncology Group performance status of 0-1
  • Left ventricular ejection fraction (LVEF) within institutional range of normal at baseline (within 42 days before randomization) as determined by either echocardiography (ECHO) or multigated acquisition (MUGA) scan
  • Adequate hematologic, hepatic and renal function
  • Estimated life expectancy ≥3 months
  • Female patients are eligible to enter and participate in the study if they are of:

    • Non-childbearing potential
    • Childbearing potential, have a negative serum pregnancy test at Screening (within 7 days of the first investigational product administration), are not breast feeding, and use highly-effective contraceptive measures before study entry and throughout the study until 6 months after the last investigational product administration.

Exclusion Criteria:

  • Previously- or currently-treated (systemic chemotherapy, biological, or targeted agent, or any other anticancer agent) recurrent or metastatic breast cancer
  • Known brain metastasis or other CNS metastasis that is either symptomatic or untreated. Central nervous system metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by computed tomography (CT) scan for at least 4 weeks before Screening without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants
  • Underlying medical conditions or current severe, uncontrolled systemic disease that, in the Investigator's opinion, will make the administration of study drug hazardous. A major surgical procedure (defined as a procedure that would require more than 3 weeks without study treatment) within 4 weeks prior to enrolment or anticipation of the need for major surgery during the course of study
  • Current uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) or unstable angina. History of chronic heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia). History of myocardial infarction within 6 months of randomization. History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy
  • History of prior exposure to doxorubicin >360 mg/m² (or equivalent)
  • Use of oral, injected or implanted hormonal methods of contraception
  • Known hypersensitivity to any of the study drugs
  • Residual non-hematologic toxicity ≥ Grade 2 from prior therapy.

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): NCT03084237


Contacts
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Contact: Binghe Xu, Doctor +86 1087788826

Locations
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China
Cancer Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Binghe Xu, Doctor    +86 1087788826      
Sponsors and Collaborators
Shanghai Henlius Biotech

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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT03084237     History of Changes
Other Study ID Numbers: HLX02-BC01
2016-000206-10 ( EudraCT Number )
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

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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
Docetaxel
Trastuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological