Trial to Compare the Efficacy and Safety of Pegfilgrastim Biosimilar in Subjects With High Risk Stage Breast Cancer Receiving Chemotherapy

NCT02768714 | Withdrawn Phase 3 DMC

• 1 other identifier: EF141
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase III, randomised, assessor-blind, parallel group, multicentre trial. At least 180 adult subjects with high-risk Stage II or Stage III / IV breast cancer will be randomised (1:1) to receive either Eurofarma's pegfilgrastim (n = 90) or Neulastim (n = 90) in 8 to 10 sites in Brazil. Subjects will undergo a maximum of 4 cycles of myelosuppressive chemotherapy (21 days per cycle).

Conditions

Breast Cancer

Keywords

Breast Cancer High risk Stage II or Stage III / IV

Outcome Measures

Primary Outcomes (1)

• Duration of severe neutropenia (grade 4) in days during chemotherapy cycle 1.

  Within the 21 Days of the first chemotherapy cycle

Secondary Outcomes (5)

• Duration of severe neutropenia (grade 4) in days during chemotherapy Cycles 2, 3, and 4

  Four months

• Incidence of febril neutropenia during chemotherapy cycles 1, 2, 3, and 4 and across all chemotherapy cycles.

  Four months

• Incidence of infections during chemotherapy cycles 1, 2, 3, and 4 and for all chemotherapy cycles combined.

  Four months

• Use of IV antibiotics to treat febril neutropenia or associated infections

  Four months

• Overall survival

  one year after the last chemotherapy cycle

Study Arms (2)

Eurofarma's pegfilgrastim

EXPERIMENTAL

A single 6 mg dose on Day 2 of each chemotherapy cycle of Eurofarma's pegfilgrastim (subcutaneous injection)

Drug: Eurofarma's pegfilgrastim

Neulastim

ACTIVE COMPARATOR

A single 6 mg dose on Day 2 of each chemotherapy cycle of Neulastim (subcutaneous injection)

Drug: Neulastim

Interventions

Eurofarma's pegfilgrastim DRUG

Eurofarma's pegfilgrastim is a clear, colourless solution for injection (6 mg/0.6 mL) provided in a single use prefilled syringe. Subjects randomised to Eurofarma's pegfilgrastim will receive 6 mg administered as a single SC injection in the abdomen, upper arm, or thigh on Day 2 of each CTX cycle, approximately 24 hours after

Eurofarma's pegfilgrastim

Neulastim DRUG

Eurofarma's pegfilgrastim is a clear, colourless solution for injection (6 mg/0.6 mL) provided in a single use prefilled syringe. Subjects randomised to Eurofarma's pegfilgrastim will receive 6 mg administered as a single SC injection in the abdomen, upper arm, or thigh on Day 2 of each CTX cycle, approximately 24 hours after

Neulastim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Males or females ≥ 18 years of age (at the time of signing consent)
• Breast cancer high-risk Stage II, or Stage III, or Stage IV (classification according to American Joint Committee on Cancer)
• Eligible to receive 4 cycles of docetaxel and doxorubicin combination CTX for the treatment of high-risk stage II, III, or IV breast cancer
• CTX-naïve
• ECOG performance status ≤ 2
• Adequate bone marrow function:
• Leucocyte count \< 50 x 109/L
• ANC ≥ 1.5 x 109/L
• Platelet count ≥ 100 x 109/L
• Haemoglobin ≥ 10 x g/dL
• Left Ventricular Ejection Fraction (LVEF) ≥ 50% by echocardiography or equivalent method (e.g. Multi Gated Acquisition scan) within 4 weeks prior to administration of the first dose of trial medication
• Alanine aminotransferase and aspartate aminotransferase \< 2.5 x upper limit of normal (ULN), alkaline phosphatase \< 5 x ULN
• Total bilirubin ≤ ULN
• Creatinine ≤ 1.5 x ULN

You may not qualify if:

• Severe chronic neutropenia
• History of chronic myeloid leukaemia or myelodysplastic syndrome
• History of sickle cell disease
• Previous or concurrent malignancy except non-invasive non-melanomatous skin cancer, in situ carcinoma of the cervix, or other solid tumour treated curatively, and without evidence of recurrence for at least 10 years prior to trial entry
• Active uncontrolled infection
• Known human immunodeficiency virus seropositivity; active hepatitis B or hepatitis C at the Screening Visit
• Clinically significant impairment of LVEF
• Severe valvular heart disease, myocardial infarction, heart failure, unstable angina pectoris, uncontrolled hypertension, or uncontrolled arrhythmias within 6 months of the Screening Visit
• Significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent
• Concurrent or prior radiotherapy within 4 weeks of the Screening Visit
• Tumour surgery within 4 weeks prior to administration of the first dose of trial medication
• Concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
• Concurrent prophylactic antibiotics or antibiotic treatment within 72 hours before CTX
• Prior bone marrow or stem cell transplant
• Previous therapy with any recombinant human granulocyte colony stimulating factor (G CSF) product

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 11, 2016
• Study Start: January 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 15, 2017

Record last verified: 2017-09