Breast Neoplasms, Chemotherapy-Induced Febrile Neutropenia
Conditions
Keywords
Pegfilgrastim, Granulocyte Colony Stimulating Factor (G-CSF), Breast Cancer, Neutropenia
Brief 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.
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.
Interventions
Sponsors
Mylan GmbH
Mylan Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The rate of febrile neutropenia (FN) | Week 24 (End of the study) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence, nature, and severity of adverse events (AEs) | Week 24 | Rate of FN listed by cycles and across cycles |
| Presence of antibodies against MYL-1401H and Pegfilgrastim | Week 24 | — |
Countries
Bulgaria, Georgia, Germany, Hungary, Poland, Ukraine
Outcome results
None listed