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Chemotherapy-induced NeutropeniaPhase 3PROTECT2NCT01516736

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

A Phase 3 study testing LA-EP2006 and Neulasta® in people with Chemotherapy-induced Neutropenia and Breast Cancer, run by Sandoz at 53 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
LA-EP2006 and Neulasta®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
53 sitesin 8 countries
Study dates
Mar 2012to Dec 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically proven breast cancer
  • eligible for six cycles of neoadjuvant or adjuvant chemotherapy

Who cannot join

  • concurrent or prior chemotherapy for breast cancer
  • concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
  • concurrent prophylactic antibiotics
  • previous therapy with any G-CSF (granulocyte-colony stimulating factor) product
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

53 sites in 8 countries.

53 sites in 8 countries

Russia17 sites

  • Sandoz Investigational Site

    Arkhangelsk, 163045

  • Sandoz Investigational Site

    Bashkortostan, 450054

  • Sandoz Investigational Site

    Bryansk, 241033

  • Sandoz Investigational Site

    Kazan', 420029

  • Sandoz Investigational Site

    Krasnoyarsk, 660133

  • Sandoz Investigational Site

    Moscow, 115478

  • Sandoz Investigational Site

    Omsk, 644046

  • Sandoz Investigational Site

    Orenburg, 460021

  • Sandoz Investigational Site

    Oryol, 302020

  • Sandoz Investigational Site

    Rostov-on-Don, 344037

  • Sandoz Investigational Site

    Saint Petersburg, 194017

  • Sandoz Investigational Site

    Saint Petersburg, 194044

  • Sandoz Investigational Site

    Saint Petersburg, 195271

  • Sandoz Investigational Site

    Saint Petersburg, 197022

  • Sandoz Investigational Site

    Saint Petersburg, 197758

  • Sandoz Investigational Site

    Tomsk, 634009

  • Sandoz Investigational Site

    Vladimir, 600021

Other trials in Russia

India14 sites

  • Sandoz Investigational Site

    Chennai, 600031

  • Sandoz Investigational Site

    Delhi, 110092

  • Sandoz Investigational Site

    Gujarat, 380009

  • Sandoz Investigational Site

    Hyderabad, 50024

  • Sandoz Investigational Site

    Karamsad, 388325

  • Sandoz Investigational Site

    Lucknow, 226003

  • Sandoz Investigational Site

    Maharashtra, 422004

  • Sandoz Investigational Site

    Mangalore, 575001

  • Sandoz Investigational Site

    Mumbai, 400010

  • Sandoz Investigational Site

    Pradesh, 520002

  • Sandoz Investigational Site

    Surat, 395010

  • Sandoz Investigational Site

    Vadodara, 391760

  • Sandoz Investigational Site

    Vellore, 632004

  • Sandoz Investigational Site

    Visakhapatnam, 530017

Other trials in India

United States10 sites

  • Sandoz Investigational Site

    Bismarck, North Dakota, 58501

  • Sandoz Investigational Site

    Corona, California, 92879

  • Sandoz Investigational Site

    Detroit, Michigan, 48202

  • Sandoz Investigational Site

    Eugene, Oregon, 97401

  • Sandoz Investigational Site

    Germantown, Tennessee, 38138

  • Sandoz Investigational Site

    Hot Springs, Arkansas, 71913

  • Sandoz Investigational Site

    Jonesboro, Arkansas, 72401

  • Sandoz Investigational Site

    Mount Sterling, Kentucky, 40353

  • Sandoz Investigational Site

    Newport News, Virginia, 23601

  • Sandoz Investigational Site

    Wichita, Kansas, 67214

Other trials in United States

Malaysia4 sites

  • Sandoz Investigational Site

    George Town, 11200

  • Sandoz Investigational Site

    George Town, 11600

  • Sandoz Investigational Site

    Kampung Baharu Nilai, 71800

  • Sandoz Investigational Site

    Kelantan, 16150

Other trials in Malaysia

Spain4 sites

  • Sandoz Investigational Site

    Barcelona, 08035

  • Sandoz Investigational Site

    Madrid, 28040

  • Sandoz Investigational Site

    Santiago de Compostela, 15706

  • Sandoz Investigational Site

    Valencia, 46014

Other trials in Spain

Puerto Rico2 sites

  • Sandoz Investigational Site

    San Juan, 00910

  • Sandoz Investigational Site

    San Juan, 00927

Other trials in Puerto Rico

Argentina1 site

  • Sandoz Investigational Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Chile1 site

  • Sandoz Investigational Site

    Temuco, 4810469

Other trials in Chile

About this study

Official title: Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®

The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Read the detailed description

The Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare the proposed biosimilar LA-EP2006 with the reference pegfilgrastim in woman with early stage breast cancer receiving (neo)-adjuvant myelosuppressive chemotherapy. Patient received TAC (intravenous docetaxel 75mg/m^2, doxorubicin 50 mg/m^2, and cyclophosphamide 500mg/m^2) on day1 of each cycle, for six or more cycles. A total of 308 patients were randomized to LA-EP2006 (n=155) or reference Neulasta® (n=153). Treatment was given subcutaneously on day 2 of each cycle. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count <0.5 × 10^9 cells/L). LA-EP2006 was equivalent to the reference product in DSN (difference: -0.16 days; 95% CI [-0.40, 0.08]). Further, LA-EP2006 and the reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety.

Being tested
LA-EP2006, Neulasta®
Keywords
Pegfilgrastim, G-CSF, neutropenia, breast cancer, myelosuppressive chemotherapy
Medical subject headings
Breast Neoplasms, Neutropenia

What participants receive

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

  • LA-EP2006Drug

    Also called pegfilgrastim

    Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.

  • Neulasta®Drug

    Also called pegfilgrastim, Neulasta

    Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle Neulasta® is injected s.c. post chemotherapy application.

Study groups in NCT01516736
Study groupRoleWhat they receive
LA-EP2006ExperimentalDuring each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
Receives: Drug: LA-EP2006
Neulasta®Active comparatorDuring each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Receives: Drug: Neulasta®

What is being measured

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

  1. Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy

    Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9/l (grade 4 neutropenia).

    Measured: 21 days (Cycle 1 of chemotherapy treatment)

Secondary outcomes (7)

  1. Incidence of Febrile Neutropenia (FN)

    FN was defined as oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN ("febrile neutropenia", "neutropenic sepsis") were taken into account.

    Measured: across all cycles (18 weeks)

  2. Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles

    Fever was defined as an oral body temperature of ≥ 38.3°C. Fever episodes were described by maximum oral temperature and the number of patients who had fever at least once.

    Measured: across al cycles (18 weeks)

  3. Depth of ANC Nadir in Cycle 1

    The depth of ANC nadir was defined as the patient's lowest ANC (10^9 cells/L) in Cycle 1.

    Measured: Cycle 1 (3 weeks)

  4. Number of Patients With ANC Nadir Per Day in Cycle 1

    Numbers of patients with ANC nadir based per day during Cycle 1 are given.

    Measured: Cycle 1 (3 weeks)

  5. Time to ANC Recovery in Days in Cycle 1

    Time to absolute neutrophil count (ANC) recovery was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10^9 cells/L after the nadir in Cycle 1.

    Measured: across Cycle 1 (3 weeks)

  6. Frequency of Infections by Cycle and Across All Cycles

    The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class "Infections and Infestations".

    Measured: across all cycles (18 weeks)

  7. Mortality Due to Infection

    Number of patients with death due to infections

    Measured: Study course (19 weeks)

Timeline

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

  1. First posted25 Jan 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionAug 2013
  4. Study completionDec 2013

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516736
Sponsor's protocol ID
LA-EP06-302
Acronym
PROTECT2
Status last verified
Aug 2017
First submitted
13 Jan 2012
Last updated
30 Aug 2017
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Blackwell K, Donskih R, Jones CM, Nixon A, Vidal MJ, Nakov R, Singh P, Schaffar G, Gascon P, Harbeck N. A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial. Oncologist. 2016 Jul;21(7):789-94. doi: 10.1634/theoncologist.2016-0011. Epub 2016 Apr 18.

    PubMed 27091420

  • Blackwell K, Gascon P, Jones CM, Nixon A, Krendyukov A, Nakov R, Li Y, Harbeck N. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Ann Oncol. 2017 Sep 1;28(9):2272-2277. doi: 10.1093/annonc/mdx303.

    PubMed 28637287

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LA-EP2006 and Neulasta® in people with Chemotherapy-induced Neutropenia and Breast Cancer, run by Sandoz at 53 sites in 8 countries.

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 2 inclusion and 5 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: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Russia, India, United States, Malaysia, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy (time frame: 21 days (Cycle 1 of chemotherapy treatment)). 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 NCT01516736, which also lists 2 linked publications.

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 30 Aug 2017.

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