This study will compare the efficacy of MYL-1401H versus Neulasta® for the treatment of chemotherapy-induced neutropenia (dangerously low levels of a type of white blood cells) in patients with stage II/III breast cancer receiving anti-cancer chemotherapy (docetaxel, doxorubicin, and cyclophosphamide)

Phase 1

Conditions: chemotherapy-induced neutropenia in patients with stage II/III breast cancer receiving docetaxel, doxorubicin, and cyclophosphamide (TAC) anti-cancer chemotherapy
MedDRA version: 18.0Level: PTClassification code 10029354Term: NeutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 18.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2014-002324-27-BG

Lead Sponsor: Mylan GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 189

Inclusion Criteria

1. Signed and dated written informed consent.
2. Patients aged = 18 years.
3. 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. Acceptable methods of contraception include nonhormonal intrauterine device and barrier methods (male condom, female condom, diaphragm or cervical cap) with spermicide. Female patients who normally abstain from sexual activity may be recruited providing they remain abstinent during the study or if they become sexually active, they must agree to use effective methods of birth control as described above.
4. Male patients without a vasectomy must agree to use a condom and their female partners of child-bearing potential must agree to use another form of contraception (hormonal contraceptives, intrauterine device, diaphragm with spermicide, or cervical cap with spermicide) during the treatment period from the first dose of study drug until 6 months following the last dose of study drug.
5. Newly diagnosed, pathologically confirmed breast cancer.
6. Stage II or III breast cancer with adequate staging workup (NCCN guidelines; Version 1.201413) and adequate surgery if receiving adjuvant therapy.
7. Patients planned/eligible to receive neoadjuvant or adjuvant treatment with TAC for their breast cancer.
8. Cancer Chemotherapy and Radiotherapy naïve.
9. Eastern Cooperative Oncology Group (ECOG) performance status = 1
10. Absolute neutrophil count = 1.5 × 10 (9)/L.
11. Platelet count = 100 × 10 (9)/L.
12. Hemoglobin > 10 g/dL without blood transfusions or cytokine support during the 2 weeks previous to the hemoglobin level.
13. Adequate cardiac function (including left ventricular ejection fraction = 50% as assessed by echocardiography) within 4 weeks prior to start of chemotherapy.
14. Adequate renal function, i.e., creatinine < 1.5 × upper limit of normal (ULN).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 189
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Participation in a clinical trial in which they received an investigational drug within 28 days before randomization.
2. Previous exposure to filgrastim, pegfilgrastim, lenograstim, lipegfilgrastim, or other filgrastims on the market or in clinical development.
3. Received blood transfusions or erythroid growth factors within 2 weeks prior to first dose of chemotherapy.
4. Known hypersensitivity to any drugs or excipients that patients will be receiving during the study.
5. Known hypersensitivity to E. coli-derived products.
6. Known fructose intolerance (related with sorbitol excipient).
7. Underlying neuropathy of grade 2 or higher.
8. 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).
9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN, ALT and/or AST > 1.5 × ULN with alkaline phosphatase (ALP) > 2.5 × ULN; any bilirubin > ULN. Any alteration of liver function and/or ALP elevation, even within acceptance limits, should be investigated before randomization to exclude any stage IV disease.
10. Treatment with systemically active antibiotics within 5 days before first dose of chemotherapy.
11. Patients under treatment with lithium.
12. Chronic use of oral corticosteroids.
13. 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.
14. 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.
15. Increase potential risk of Adult Respiratory Distress Syndrome.
16. Pregnant or nursing women.
17. 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.
18. A known active abuse of drugs or alcohol should preclude patient participation and evaluation in the study.
19. Any known psychiatric conditions.
20. 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 & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to compare the efficacy of MYL-1401H versus Neulasta® for the prophylactic treatment of chemotherapy-induced neutropenia in patients with stage II/III breast cancer receiving TAC anti-cancer chemotherapy.;Secondary Objective: - To assess the safety of MYL-1401H and Neulasta® when administered through 6 cycles of TAC anti-cancer chemotherapy<br>- To assess the potential immunogenicity of MYL-1401H and Neulasta® during chemotherapy and up to 24 weeks following the first administration;Primary end point(s): The primary endpoint of this study is the DSN in Cycle 1, defined as days with ANC < 0.5 × 10 (9) /L. ;Timepoint(s) of evaluation of this end point: Cycle 1

Secondary Outcome Measures

Name	Time	Method

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