Efficacy and Safety Study With MYL-1401H and Neulasta

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT02467868
• Date of registration: 08/06/2015
• Prospective Registration: No
• Primary sponsor: Mylan Inc.
• Public title: Efficacy and Safety Study With MYL-1401H and Neulasta
• Scientific 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
• Date of first enrolment: March 2015
• Target sample size: 193
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02467868
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Georgia, Germany, Hungary, Poland, Ukraine

Contacts

• Name: Rasmus Rojkjaer, MD
• Affiliation: Mylan GmbH

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chemotherapy-Induced Febrile Neutropenia

Breast Neoplasms

Intervention(s)

Biological: MYL-1401H

Biological: Neulasta

Primary Outcome(s)

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)]

Secondary Outcome(s)

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

Secondary ID(s)

2014-002324-27

MYL-1401H-3001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mylan GmbH