Efficacy and Safety Study With MYL-1401H and Neulasta

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467868
• Other study ID #: MYL-1401H-3001
• Secondary ID: 2014-002324-27
• Status: Completed
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: February 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Chemotherapy-Induced Febrile Neutropenia
• Febrile Neutropenia
• Neutropenia

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Mylan GmbH

Countries where clinical trial is conducted

Bulgaria,  Georgia,  Germany,  Hungary,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence, nature, and severity of adverse events (AEs)	Rate of FN listed by cycles and across cycles	Week 24
Other	Presence of antibodies against MYL-1401H and Pegfilgrastim		Week 24
Primary	Mean Duration of Severe Neutropenia (DSN), defined as consecutive days with absolute neutrophil count (ANC) < 0.5 × 109/L		Cycle 1 of chemotherapy (approx 21 days)
Secondary	The rate of febrile neutropenia (FN)		Week 24 (End of the study)