- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02768714
Trial to Compare the Efficacy and Safety of Pegfilgrastim Biosimilar in Subjects With High Risk Stage Breast Cancer Receiving Chemotherapy
September 14, 2017 updated by: Eurofarma Laboratorios S.A.
A Randomized, Assessor-blind, Parallel Group, Multicentre Phase III Trial to Compare the Efficacy and Safety of Eurofarma's Pegfilgrastim to Neulastim® in Subjects With High Risk Stage II or Stage III / IV Breast Cancer Receiving Chemotherapy.
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of trial treatment and agree to use highly effective contraception (e.g. hormonal contraception or intra-uterine device [which should be established prior to the start of the trial], plus usage by at least 1 of the partners of an additional spermicide-containing barrier method of contraception) from 2 weeks prior to administration of the first dose of trial medication until trial completion, and for 30 days after the last dose of trial drug
- Female subjects of non-childbearing potential must have a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. A male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from 2 weeks prior to administration of the first dose of trial medication until trial completion, and for 30 days after the last dose of trial drug
- Able to comply with the trial Protocol.
Exclusion Criteria:
- 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
- Known hypersensitivity to docetaxel, doxorubicin, pegfilgrastim, filgrastim, Escherichia coli proteins, or any of the excipients used in the trial medication
- Treatment with lithium at randomization
- Known controlled drug addiction, including alcoholism
- Participation in a clinical trial within 30 days prior to the Screening Visit
- Pregnant or nursing women, women planning to become pregnant, or women of childbearing potential who do not agree to use highly effective contraception (e.g. hormonal contraception or intra-uterine device [which should be established prior to the start of the trial], plus usage by at least 1 of the partners of an additional spermicide-containing barrier method of contraception) from 2 weeks prior to administration of the first dose of trial medication until trial completion and for 30 days after the last dose of trial drug
- Male subjects with a female partner of childbearing potential who have not had a prior vasectomy and do not agree to use highly effective contraception from 2 weeks prior to administration of the first dose of trial medication until trial completion and for 30 days after the last dose of trial drug
- Any severe concurrent disease or condition, which in the judgment of the Investigator would make the subject inappropriate for trial participation.
- Peripheral neuropathy (sensory/motor) Grade 2 or higher (CTCAE, Version 4.03)
- Chronic use of corticosteroids.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eurofarma's pegfilgrastim
A single 6 mg dose on Day 2 of each chemotherapy cycle of Eurofarma's pegfilgrastim (subcutaneous injection)
|
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
|
Active Comparator: Neulastim
A single 6 mg dose on Day 2 of each chemotherapy cycle of Neulastim (subcutaneous injection)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of severe neutropenia (grade 4) in days during chemotherapy cycle 1.
Time Frame: Within the 21 Days of the first chemotherapy cycle
|
Within the 21 Days of the first chemotherapy cycle
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of severe neutropenia (grade 4) in days during chemotherapy Cycles 2, 3, and 4
Time Frame: Four months
|
Four months
|
Incidence of febril neutropenia during chemotherapy cycles 1, 2, 3, and 4 and across all chemotherapy cycles.
Time Frame: Four months
|
Four months
|
Incidence of infections during chemotherapy cycles 1, 2, 3, and 4 and for all chemotherapy cycles combined.
Time Frame: Four months
|
Four months
|
Use of IV antibiotics to treat febril neutropenia or associated infections
Time Frame: Four months
|
Four months
|
Overall survival
Time Frame: one year after the last chemotherapy cycle
|
one year after the last chemotherapy cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2018
Primary Completion (Anticipated)
October 1, 2019
Study Completion (Anticipated)
October 1, 2019
Study Registration Dates
First Submitted
May 9, 2016
First Submitted That Met QC Criteria
May 10, 2016
First Posted (Estimate)
May 11, 2016
Study Record Updates
Last Update Posted (Actual)
September 15, 2017
Last Update Submitted That Met QC Criteria
September 14, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EF141
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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