AzTrials
AzTrials

NeutropeniaPhase 3NCT02953340

SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide

A Phase 3 study testing SPI-2012, Pegfilgrastim and Docetaxel in people with Neutropenia and Breast Cancer, run by Spectrum Pharmaceuticals, Inc at 74 sites in 6 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 purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neutropenia, Breast Cancer
What is being tested?
SPI-2012, Pegfilgrastim and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
237 participants
Where
74 sitesin 6 countries
Study dates
10 May 2017to 6 May 2019
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
  • Candidate for adjuvant or neo-adjuvant TC chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2
  • Absolute neutrophil count (ANC) >=1.5×10^9/L
  • Platelet count >=100×10^9/L
  • Hemoglobin >9 g/dL
Show all 10Show fewer
  • Calculated creatinine clearance > 50 mL/min
  • Total bilirubin <=1.5 mg/dL
  • Aspartate aminotransferase (AST) / Serum glutamic oxaloacetic transaminase (SGOT) and Alanine aminotransferase (ALT)/Serum glutamic pyruvic transaminase (SGPT) <=2.5×ULN (upper limit of normal)
  • Alkaline phosphatase <=2.0×ULN

Who cannot join

  • Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
  • Locally recurrent/metastatic breast cancer
  • Known sensitivity to E. coli-derived products
  • Concurrent adjuvant cancer therapy
  • Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug
  • Active infection, receiving anti-infectives, or any underlying medical condition that would impair ability to receive protocol treatment
Show all 9Show fewer
  • Prior bone marrow or stem cell transplant
  • Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study• Radiation therapy within 30 days prior to enrollment
  • Major surgery within 30 days prior to enrollment

Trial locations and contacts

74 sites in 6 countries.

74 sites in 6 countries

United States49 sites

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • CHI St Joseph Health Cancer Center

    Bryan, Texas, 77802

  • Aultman Hospital

    Canton, Ohio, 44710

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433

  • Commonwealth Hematology-Oncology, PSC

    Danville, Kentucky, 40422

  • Denver Health & Hospital Authority

    Denver, Colorado, 80204

  • Cancer Center of Middle Georgia

    Dublin, Georgia, 31021

  • Providence Regional Center Partnership

    Everett, Washington, 98201

  • Dwight D. Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905

  • Compassionate Care Research Group, Inc.

    Fountain Valley, California, 92708

  • California Cancer Associates for Research and Excellence Inc.

    Fresno, California, 93720

  • Gaston Hematology & Oncology Associates, PC

    Gastonia, North Carolina, 28054

  • The West Clinic, PC, d/b/a West Cancer Center

    Germantown, Tennessee, 38138

  • CHI Health St Francis, St Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401

  • Pasco Pinellas Cancer Center

    Holiday, Florida, 34691

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • FPN Oncology and Hematology Specialists

    Indianapolis, Indiana, 46237

  • NEA Baptist Clinic | Fowler Family Center for Cancer Care

    Jonesboro, Arkansas, 72401

  • Freeman Health Systems

    Joplin, Missouri, 64804

  • Envision Cancer Center, LLC

    Laredo, Texas, 78041

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • Texas Oncology, PA- McAllen South 2nd Street

    McAllen, Texas, 78503

  • Lakes Research, LLC

    Miami Lakes, Florida, 33014

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Mid-Florida Hematology and Oncology Centers

    Orange City, Florida, 32763

  • Desert Regional Medical Center

    Palm Springs, California, 92262

  • Oncology Specialists, SC

    Park Ridge, Illinois, 60068

  • Millennium Oncology

    Pembroke Pines, Florida, 33024

  • BRCR Medical Center Inc

    Plantation, Florida, 33324

  • Delta Hematology/Oncology Associates

    Portsmouth, Virginia, 23704

  • Emad Ibrahim, MD, INC.

    Redlands, California, 92373

  • Carolina Blood and Cancer Care Associates

    Rock Hill, South Carolina, 29732

  • Quest Research Institute

    Royal Oak, Michigan, 48073

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Pinellas Hematology and Oncology

    St. Petersburg, Florida, 33709

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • ACRC/ Arizona Clinical Research Center Inc.

    Tucson, Arizona, 85715

  • HOPE Cancer Center of East Texas

    Tyler, Texas, 75701

  • Innovative Clinical Research Institute/ The Oncology Institute of Hope and Innovation

    Whittier, California, 90603

  • Bond & Steele Clinic, PA.

    Winter Haven, Florida, 33880

  • St. Elizabeth Youngstown Hospital JACBCC/Oncology/ Mercy Health Youngstown LLC

    Youngstown, Ohio, 44501

  • Yuma Regional Cancer Center

    Yuma, Arizona, 85364

Other trials in United States

South Korea8 sites

  • Seoul National University Hospital

    Daehwa-ro, Jongno-gu Seoul, 03080

  • National Cancer Center

    IIsan-ro, Gyeonggi-do, 10408

  • Wonju Severance Christian Hospital

    Ilsan-ro, Gangwon-do, 26426

  • Korea University Anam Hospital

    Inchon-ro, Seongbuk-guSeoul, 02841

  • Inha University Hospital

    Inhang-ro, Jung-guIncheon, 22332

  • Samsung Medical Center

    Irwon-ro, Gangnam-gu Seoul, 06351

  • Cha Bundang Medical Center

    Yatap-ro, Gyeonggi-do, 13496

  • Severance Hospital

    Yonsei-ro, Seoul, 03722

Other trials in South Korea

Poland7 sites

  • BIALOSTOCKIE CENTRUM ONKOLOGII im. Marii Sklodowskiej-Curie Oddzial Onkologii Klinicznej im. Ewy Pileckiej z Pododdzialem Chemioterapii dziennej

    Bialystok, 15-027

  • Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Oddział Onkologii Klinicznej

    Grudziądz, 86-300

  • Instytut Centrum Zdrowia Matki Polki Klinika Chirurgii Onkologicznej i Chorob Piersi z Pododdzialem Onkologii Klinicznej

    Lodz, 93-338

  • Pracownia Leku Cytotoksycznego Szpitala Klinicznego Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu

    Poznan, 60-569

  • Szpital Rejonowy im. Dr. Jozefa Rostka w Raciborzu Dzienny Oddzial Chemioterapii

    Racibórz, 47-400

  • MrukMed. Lekarz Beata Madej Mruk i Partner. Spolka Partnerska Oddzial nr 1 w Rzeszowie

    Rzeszów, 35-021

  • Zachodniopomorskie Centrum Onkologii Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

    Szczecin, 71-730

Other trials in Poland

Hungary6 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly

    Budapest, 1062

  • Szent Imre Egyetemi Oktatokorhaz, Klinikai Onkologiai Osztaly

    Budapest, 1115

  • Orszagos Onkologiai Intezet, ""B"" Belgyogyaszati Onkologiai Osztaly

    Budapest, 1122

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato Korhaz, Klinikai Onkologiai es Sugarterapias Centrum

    Miskolc, 3526

  • Szabolcs-Szatmar-Bereg Megyei Korhazak, Egyetemi Oktato Korhaz, Onkoradiologiai Osztaly

    Nyíregyháza, 4400

  • Tolna Megyei Balassa Janos Korhaz, Klinikai Onkologiai Osztaly

    Szekszárd, 7100

Other trials in Hungary

Canada2 sites

  • CISSS de la Montérégie-Centre

    Longueuil, Quebec, J4V 2H1

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

Other trials in Canada

India2 sites

  • KEM Hospital Research Centre

    Pune, Maharashtra, 411011

  • Christian Medical College

    Vellore, Tamil Nadu, 632004

Other trials in India

About this study

Official title: Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)

The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN).

Read the detailed description

This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer treated with TC chemotherapy as measured by the duration of severe neutropenia (DSN).

Each cycle was 21 days. Four cycles were evaluated for this study. On Day 1 of each cycle, participants received TC chemotherapy. On Day 2 of each cycle, participants received study drug (SPI-2012 or pegfilgrastim).

After cycle 1, as applicable, participants who received at least one dose of study drug will be followed for safety for 12 months after the last dose of study treatment.

Being tested
SPI-2012, Pegfilgrastim, Docetaxel, Cyclophosphamide
Keywords
Neutropenia, Breast Cancer, Long-acting Granulocyte Colony Stimulating Factor, Early Stage Breast Cancer, Docetaxel + Cyclophosphamide (TC) chemotherapy
Medical subject headings
Neutropenia, Breast Neoplasms

What participants receive

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

  • SPI-2012Drug

    Also called HM10460A, Rolontis®, Eflapegrastim

    Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle

  • PegfilgrastimDrug

    Also called Neulasta®

    Subcutaneous injection administered on Day 2 of each cycle.

  • DocetaxelDrug

    Also called Taxotere

    75mg/m^2 IV infusion administered on Day 1 of each cycle

  • CyclophosphamideDrug

    Also called Cytoxan

    600mg/m^2 IV infusion administered on Day 1 of each cycle

Study groups in NCT02953340
Study groupRoleWhat they receive
(Arm 1): SPI-2012 and TCExperimentalAt each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), [3.6 mg granulocyte colony-stimulating factor {G-CSF}] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
Receives: Drug: SPI-2012; Drug: Docetaxel; Drug: Cyclophosphamide
(Arm 2): Pegfilgrastim and TCExperimentalAt each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
Receives: Drug: Pegfilgrastim; Drug: Docetaxel; Drug: Cyclophosphamide

What is being measured

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

  1. Duration of Severe Neutropenia (DSN) in Cycle 1

    DSN was defined as the number of days of severe neutropenia (absolute neutrophil count [ANC] <0.5×10^9 per liter [L]) from the first occurrence of ANC below the threshold.

    Measured: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

Secondary outcomes (9)

  1. Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1

    Time to ANC recovery was defined as the time from chemotherapy administration until the participants ANC increased to >=1.5×10^9/L after the expected nadir. For participants with ANC value >=1.5×10^9/L at all times, time to ANC Recovery was assigned a value of 0.

    Measured: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

  2. Depth of ANC Nadir in Cycle 1

    The depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or pegfilgrastim) in Cycle 1.

    Measured: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

  3. Number of Participants With Febrile Neutropenia (FN) in Cycle 1

    FN was defined as an oral temperature >38.3 degree Celsius (°C) (101.0 degrees Fahrenheit [°F]) or two consecutive readings of >38.0°C (100.4°F) for 2 hours and ANC <1.0×10^9/L.

    Measured: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

  4. Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4

    DSN was defined as the number of days of severe neutropenia (ANC <0.5×10^9/L) from the first occurrence of ANC below the threshold.

    Measured: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)

  5. Number of Participants With Neutropenic Complications in Cycle 1

    Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.

    Measured: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

  6. Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4

    FN was defined as an oral temperature >38.3°C (101.0°F) or two consecutive readings of >38.0°C (100.4°F) for 2 hours and ANC <1.0×10^9/L.

    Measured: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)

  7. Relative Dose Intensity (RDI) of TC Chemotherapy

    RDI was defined as the percentage of the planned dose of TC chemotherapy that each participant actually received during the study, and is expressed as the total dose received, divided by total dose planned multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles.

    Measured: Cycles 1, 2, 3 and 4 (each cycle = 21 days)

  8. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death

    An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE is any AE that occurred from the first dose of study treatment through 12 months after the last dose of study treatment or 35 (±5) days after date of participant early discontinuation. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events.

    Measured: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)

  9. Number of Participants With Clinically Significant Laboratory Abnormalities

    The number of participants with clinically significant hematology (including basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils, neutrophils/leukocytes, platelets, and white blood cells) and serum chemistry (including alanine aminotransferase [ALT], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin, calcium, cholesterol, creatinine, potassium, sodium, and triglycerides) laboratory abnormalities were reported. Clinically significant findings in laboratory parameters were based on investigator's discretion according to Common Technical Criteria for Adverse Events (CTCAE) Version 4.03.

    Measured: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)

Timeline

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

  1. First posted2 Nov 2016 (estimated)
  2. Study start10 May 2017
  3. Primary completion8 Jun 2018
  4. Study completion6 May 2019

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
None (open label)
Enrolment
237 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02953340
Sponsor's protocol ID
SPI-GCF-302
Other IDs
2016-003469-24, 2016
Status last verified
Jan 2022
First submitted
27 Oct 2016
Last updated
2 Mar 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPI-2012, Pegfilgrastim and Docetaxel in people with Neutropenia and Breast Cancer, run by Spectrum Pharmaceuticals, Inc at 74 sites in 6 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 10 inclusion and 9 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, South Korea, Poland, Hungary, Canada and 1 more country. 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 2 Mar 2022). 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?

Duration of Severe Neutropenia (DSN) in Cycle 1 (time frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)). 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 NCT02953340.

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 2 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in