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Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer

NCT03084237

Description:

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.

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: HLX02-BC01
  • SECONDARY ID: 2016-000206-10
  • NCT ID: NCT03084237

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
HLX02HLX02+docetaxel
Herceptin®Herceptin®+docetaxel
docetaxelHLX02+docetaxel

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
HLX02+docetaxelExperimental
  • HLX02
  • docetaxel
Herceptin®+docetaxelActive Comparator
  • Herceptin®
  • docetaxel

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:ORR 24 weeks
Time Frame:From time of First treatment to week 24
Safety Issue:
Description: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

Measure:PFS up to 12 months
Time Frame:From time of first treatment to 12 months
Safety Issue:
Description:
Measure:Overall survival at 12, 24, and 36 months
Time Frame:From time of first treatment to 36 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Shanghai Henlius Biotech

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