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Breast NeoplasmsPhase 3NCT02467868

Efficacy and Safety Study With MYL-1401H and Neulasta

A Phase 3 study testing MYL-1401H and Neulasta in people with Breast Neoplasms and Chemotherapy-Induced Febrile Neutropenia, run by Mylan Inc. at 36 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MYL-1401H and Neulasta
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
36 sitesin 6 countries
Study dates
Mar 2015to Feb 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

36 sites in 6 countries.

36 sites in 6 countries

Ukraine10 sites

  • Mylan Investigational SIte 3804

    Chernivtsi

  • Mylan Investigational site 3801

    Dniepropetrovsk

  • Mylan Investigational Site 3805

    Dniepropetrovsk

  • Mylan Investigational Site 3808

    Kharkiv

  • Mylan Investigational Site 3810

    Kyiv

  • Mylan Investigatational Site 3802

    Lutsk

  • Mylan Investigational SIte 3807

    Lviv

  • Mylan Investigational SIte 3803

    Odesa

  • Mylan Investigational Site 3809

    Sumy

  • Mylan Investigational Site 3806

    Uzhhorod

Other trials in Ukraine

Hungary8 sites

  • Mylan Investigational Site 3604

    Budapest

  • Mylan Investigational SIte 3606

    Budapest

  • Mylan Investigational Site 3607

    Budapest

  • Mylan Investigational Site 3609

    Debrecen

  • Mylan Investigational Site 3601

    Gyula

  • Mylan Investigational SIte 3605

    Nyíregyháza

  • Mylan Investigational Site 3603

    Szombathely

  • Mylan Investigational Site 3602

    Zalaegerszeg

Other trials in Hungary

Bulgaria7 sites

  • Mylan Investigational Site 3502

    Plovdiv

  • Mylan Investigational Site 3506

    Plovdiv

  • Mylan Investigational Site 3507

    Plovdiv

  • Mylan Investigational Site 3503

    Sofia

  • Mylan Investigational Site 3505

    Sofia

  • Mylan Investigational Site 3504

    Varna

  • Mylan Investigational SIte 3501

    Veliko Tarnovo

Other trials in Bulgaria

Georgia7 sites

  • Mylan Investigational Site 9901

    Tbilisi

  • Mylan Investigational Site 9902

    Tbilisi

  • Mylan Investigational Site 9903

    Tbilisi

  • Mylan Investigational Site 9904

    Tbilisi

  • Mylan Investigational Site 9905

    Tbilisi

  • Mylan Investigational Site 9906

    Tbilisi

  • Mylan Investigational Site 9907

    Tbilisi

Other trials in Georgia

Poland3 sites

  • Mylan Investigational site 4802

    Bydgoszcz

  • Mylan Investigational Site 4805

    Kościerzyna

  • Mylan Investigational SIte 4804

    Krakow

Other trials in Poland

Germany1 site

  • Mylan Investigational site 4905

    Bonn

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
MYL-1401H, Neulasta
Keywords
Pegfilgrastim, Granulocyte Colony Stimulating Factor (G-CSF), Breast Cancer, Neutropenia
Medical subject headings
Breast Neoplasms, Chemotherapy-Induced Febrile Neutropenia, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MYL-1401HBiological

    Also called Pegfilgrastim, Recombinant human granulocyte colony-stimulating factor (G-CSF)

    During each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy.

  • NeulastaBiological

    Also called Pegfilgrastim, Recombinant human granulocyte colony-stimulating factor (G-CSF)

    During each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy.

Study groups in NCT02467868
Study groupRoleWhat they receive
MYL-1401HExperimentalMYL-1401H
Receives: Biological: MYL-1401H
NeulastaActive comparatorNeulasta
Receives: Biological: Neulasta

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Duration of Severe Neutropenia (DSN), defined as consecutive days with absolute neutrophil count (ANC) < 0.5 × 109/L

    Measured: Cycle 1 of chemotherapy (approx 21 days)

Secondary outcomes (1)

  1. The rate of febrile neutropenia (FN)

    Measured: Week 24 (End of the study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionSep 2015
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02467868
Sponsor's protocol ID
MYL-1401H-3001
Other IDs
2014-002324-27, 2014
Status last verified
Feb 2022
First submitted
8 Jun 2015
Last updated
14 Feb 2022
Results posted
No
Data monitoring committee
No

Publications

  • Waller CF, Ranganna GM, Pennella EJ, Blakeley C, Bronchud MH, Mattano LA Jr, Berzoy O, Voitko N, Shparyk Y, Lytvyn I, Rusyn A, Popov V, Lang I, Beckmann K, Sharma R, Baczkowski M, Kothekar M, Barve A. Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia. Ann Hematol. 2019 May;98(5):1217-1224. doi: 10.1007/s00277-019-03639-5. Epub 2019 Mar 1.

    PubMed 30824956

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MYL-1401H and Neulasta in people with Breast Neoplasms and Chemotherapy-Induced Febrile Neutropenia, run by Mylan Inc. at 36 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Ukraine, Hungary, Bulgaria, Georgia, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02467868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.

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