Efficacy and Safety Study With MYL-1401H and Neulasta

February 10, 2022 updated by: Mylan Inc.

Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and European Sourced Neulasta® in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy

This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After successful screening, eligible patients will be randomly allocated to one of the two study arms, either receiving MYL-1401H or Neulasta.

Randomization is 2:1 to MYL-1401H or Neulasta, respectively.

Subjects will receive first of six cycles of background therapy (Docetaxel, Doxorubicin, Cyclophosphamide [TAC]) on day 1. Treatment with study drug (either MYL-1401H or Neulasta) is scheduled on Day 2 of each cycle, at least 24 hours after chemotherapy administration.

Duration of each cycle is 3 weeks.

Follow-up visit is scheduled 24 weeks after the first administration of study drug.

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria
        • Mylan Investigational Site 3502
      • Plovdiv, Bulgaria
        • Mylan Investigational Site 3506
      • Plovdiv, Bulgaria
        • Mylan Investigational Site 3507
      • Sofia, Bulgaria
        • Mylan Investigational Site 3503
      • Sofia, Bulgaria
        • Mylan Investigational Site 3505
      • Tarnovo, Bulgaria
        • Mylan Investigational SIte 3501
      • Varna, Bulgaria
        • Mylan Investigational Site 3504
  • Georgia
      • Tbilisi, Georgia
        • Mylan Investigational Site 9901
      • Tbilisi, Georgia
        • Mylan Investigational Site 9902
      • Tbilisi, Georgia
        • Mylan Investigational Site 9903
      • Tbilisi, Georgia
        • Mylan Investigational Site 9904
      • Tbilisi, Georgia
        • Mylan Investigational Site 9905
      • Tbilisi, Georgia
        • Mylan Investigational Site 9906
      • Tbilisi, Georgia
        • Mylan Investigational Site 9907
  • Germany
      • Bonn, Germany
        • Mylan Investigational site 4905
  • Hungary
      • Budapest, Hungary
        • Mylan Investigational Site 3604
      • Budapest, Hungary
        • Mylan Investigational SIte 3606
      • Budapest, Hungary
        • Mylan Investigational Site 3607
      • Debrecen, Hungary
        • Mylan Investigational Site 3609
      • Gyula, Hungary
        • Mylan Investigational Site 3601
      • Nyiregyhaza, Hungary
        • Mylan Investigational SIte 3605
      • Szombathely, Hungary
        • Mylan Investigational Site 3603
      • Zalaegerszeg, Hungary
        • Mylan Investigational Site 3602
  • Poland
      • Bydgoszcz, Poland
        • Mylan Investigational site 4802
      • Koscierzyna, Poland
        • Mylan Investigational Site 4805
      • Krakow, Poland
        • Mylan Investigational SIte 4804
  • Ukraine
      • Chernivtsi, Ukraine
        • Mylan Investigational SIte 3804
      • Dniepropetrovsk, Ukraine
        • Mylan Investigational site 3801
      • Dniepropetrovsk, Ukraine
        • Mylan Investigational Site 3805
      • Kharkiv, Ukraine
        • Mylan Investigational Site 3808
      • Kyiv, Ukraine
        • Mylan Investigational Site 3810
      • Lutsk, Ukraine
        • Mylan Investigatational Site 3802
      • Lviv, Ukraine
        • Mylan Investigational SIte 3807
      • Odesa, Ukraine
        • Mylan Investigational SIte 3803
      • Sumy, Ukraine
        • Mylan Investigational Site 3809
      • Uzhgorod, Ukraine
        • Mylan Investigational Site 3806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated written informed consent.
  • Patients ≥18 years.
  • Women of child-bearing potential must agree to use effective methods of birth control during the treatment period from the first dose of study drug until 6 months following the last dose of study drug.
  • Newly diagnosed, pathologically confirmed breast cancer.
  • Stage II or III breast cancer with adequate staging workup and adequate surgery if receiving adjuvant therapy.
  • Patients planned/eligible to receive neoadjuvant or adjuvant treatment with (Docetaxel, Doxorubicin, Cyclophosphamide [TAC]) for their breast cancer.
  • Cancer Chemotherapy and Radiotherapy naïve.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Absolute neutrophil count ≥ 1.5 × 109/L ; Platelet count ≥ 100 × 109/L ;
  • Hemoglobin > 10 g/dL without blood transfusions or cytokine support during the two weeks previous to the hemoglobin level.
  • Adequate cardiac function (including left ventricular ejection fraction ≥ 50% as assessed by echocardiography) within 4 weeks prior to start of chemotherapy.
  • Adequate renal function, i.e., creatinine < 1.5 × upper limit of normal (ULN).

Other protocol specific inclusion/exclusion criteria may apply

Exclusion Criteria:

  • Participation in a clinical trial in which they received an investigational drug within 28 days before randomization.
  • Previous exposure to filgrastim, pegfilgrastim, lenograstim, lipegfilgrastim, or other filgrastim forms on the market or in clinical development.
  • Received blood transfusions or erythroid growth factors within 2 weeks prior to first dose of chemotherapy.
  • Known hypersensitivity to any drugs or excipients that patients will be receiving during the study.
  • Known hypersensitivity to E. coli-derived products.
  • Known fructose intolerance (related with sorbitol excipient).
  • Underlying neuropathy of grade 2 or higher.
  • Active infectious disease or any other medical condition which might put the patient at significant risk to tolerate 6 courses of TAC chemotherapy (e.g., recent myocardial infarction).
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × Upper limit of normal (ULN), ALT and/or AST > 1.5 × ULN with alkaline phosphatase (ALP) > 2.5 × ULN; any bilirubin > ULN.
  • Treatment with systemically active antibiotics within 5 days before first dose of chemotherapy.
  • Patients under treatment with lithium.
  • Chronic use of oral corticosteroids.
  • Splenomegaly of unknown origin by physical examination and/or computerized tomography scan or ultrasound and any condition which can cause splenomegaly, e.g., thalassemia, glandular fever, hemolytic anemias, and malaria.
  • Myeloproliferative or myelodysplastic disorders, sickle cell disorders, and any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint.
  • Increase potential risk of Adult Respiratory Distress Syndrome.
  • Pregnant or nursing women.
  • Patients known to be seropositive for human immunodeficiency virus (HIV), or who have had an acquired immunodeficiency syndrome (AIDS) defining illness or a known immunodeficiency disorder.
  • A known active abuse of drugs or alcohol should preclude patient participation and evaluation in the study.
  • Any known psychiatric conditions.
  • Any disease or physical condition that may not allow for the adequate performance of study assessments, such as lack of access to patient's domiciliary, and distance of patient's domiciliary from clinic site.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MYL-1401H
Biological: MYL-1401H
During each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy.
Other Names:
  • Pegfilgrastim
  • Recombinant human granulocyte colony-stimulating factor (G-CSF)
Active Comparator: Neulasta
Biological: Neulasta
During each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy.
Other Names:
  • Pegfilgrastim
  • Recombinant human granulocyte colony-stimulating factor (G-CSF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Duration of Severe Neutropenia (DSN), defined as consecutive days with absolute neutrophil count (ANC) < 0.5 × 109/L
Time Frame: Cycle 1 of chemotherapy (approx 21 days)
Cycle 1 of chemotherapy (approx 21 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of febrile neutropenia (FN)
Time Frame: Week 24 (End of the study)
Week 24 (End of the study)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence, nature, and severity of adverse events (AEs)
Time Frame: Week 24
Rate of FN listed by cycles and across cycles
Week 24
Presence of antibodies against MYL-1401H and Pegfilgrastim
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Inc.

Collaborators

Mylan GmbH

Investigators

  • Study Chair: Rasmus Rojkjaer, MD, Mylan GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYL-1401H-3001
  • 2014-002324-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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