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AzTrials

Breast CancerPhase 3NCT02768714

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

A Phase 3 study testing Eurofarma's pegfilgrastim and Neulastim in people with Breast Cancer, run by Eurofarma Laboratorios S.A..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Eurofarma's pegfilgrastim and Neulastim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2018to Oct 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

About this study

Official title: 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).

Conditions
Breast Cancer
Being tested
Eurofarma's pegfilgrastim, Neulastim
Keywords
Breast Cancer High risk Stage II or Stage III / IV
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eurofarma's pegfilgrastimDrug

    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

  • NeulastimDrug

    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

Study groups in NCT02768714
Study groupRoleWhat they receive
Eurofarma's pegfilgrastimExperimentalA single 6 mg dose on Day 2 of each chemotherapy cycle of Eurofarma's pegfilgrastim (subcutaneous injection)
Receives: Drug: Eurofarma's pegfilgrastim
NeulastimActive comparatorA single 6 mg dose on Day 2 of each chemotherapy cycle of Neulastim (subcutaneous injection)
Receives: Drug: Neulastim

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Within the 21 Days of the first chemotherapy cycle

Secondary outcomes (5)

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

    Measured: Four months

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

    Measured: Four months

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

    Measured: Four months

  4. Use of IV antibiotics to treat febril neutropenia or associated infections

    Measured: Four months

  5. Overall survival

    Measured: one year after the last chemotherapy cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2016 (estimated)
  2. Study startJan 2018 (estimated)
  3. Primary completionOct 2019 (estimated)
  4. Study completionOct 2019 (estimated)

Why it stopped: Strategic changes regarding the product development

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02768714
Sponsor's protocol ID
EF141
Status last verified
Sep 2017
First submitted
9 May 2016
Last updated
15 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eurofarma's pegfilgrastim and Neulastim in people with Breast Cancer, run by Eurofarma Laboratorios S.A..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of severe neutropenia (grade 4) in days during chemotherapy cycle 1. (time frame: Within the 21 Days of the first chemotherapy cycle). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02768714.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.

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