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NeutropeniaPhase 3ADVANCENCT02643420

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

A Phase 3 study testing SPI-2012, Pegfilgrastim and Docetaxel in people with Neutropenia and Breast Cancer, run by Spectrum Pharmaceuticals, Inc at 81 sites in 3 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 was to compare the efficacy of a single dose 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) in Cycle 1. 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
406 participants
Where
81 sitesin 3 countries
Study dates
19 Jan 2016to 31 Oct 2018
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 neoadjuvant TC chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
  • Absolute neutrophil count (ANC) ≥ 1.5×10^9/L
  • Platelet count ≥ 100×10^9/L
  • Hemoglobin > 9 g/dL
Show all 10Show fewer
  • Creatinine clearance > 50 mL/min
  • Total bilirubin ≤ 1.5 mg/dL
  • Aspartate Aminotransferase per Serum Glutamic-Oxaloacetic Transaminase (AST/SGOT) and Alanine Aminotransferase per Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) ≤ 2.5× Upper Limit of Normal (ULN).
  • 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 or metastatic breast cancer
  • Known sensitivity to E. coli -derived products or to any products to be administered during dosing
  • 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 serious underlying medical condition that would impair ability to receive protocol treatment
Show all 10Show fewer
  • Prior bone marrow or stem cell transplant
  • Use of 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

81 sites in 3 countries.

81 sites in 3 countries

United States76 sites

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Ashland-Bellefonte Cancer Center

    Ashland, Kentucky, 41101

  • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Alta Bates Summit Medical Center

    Berkeley, California, 94704

  • RCCA MD LLC/The Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • New Jersey Hematology Oncology Associates

    Brick, New Jersey, 08724

  • CHI St. Joseph Health Cancer Center

    Bryan, Texas, 77802

  • Aultman Hospital

    Canton, Ohio, 44710

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Clintell, Inc/Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • Precision Research Institute, LLC

    Chula Vista, California, 91910

  • The Lindner Research Center at the Christ Hospital

    Cincinnati, Ohio, 45219

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Compassionate Cancer Care Medical Group, Inc.

    Corona, California, 92879

  • Good Samaritan Hospital Corvallis

    Corvallis, Oregon, 97330

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433

  • Texas Oncology -Methodist Dallas Cancer Center

    Dallas, Texas, 75203

  • Omega Research Consultants LLC

    DeBary, Florida, 32713

  • North Shore Hematology Oncology Associates

    East Setauket, New York, 11733

  • Dwight D. Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905

  • Compassionate Care Research Group, Inc.

    Fountain Valley, California, 92708

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

    Germantown, Tennessee, 38138

  • Arizona Center for Cancer Care

    Glendale, Arizona, 85306

  • Saint Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • Bon Secours Saint Francis Cancer

    Greenville, South Carolina, 29607

  • Forrest General Hospital

    Hattiesburg, Mississippi, 39401

  • Pasco Pinellas Cancer Center

    Holiday, Florida, 34691

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Oncology Consultants

    Houston, Texas, 77030

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • Joliet Oncology Hematology Associates

    Joliet, Illinois, 60435

  • NEA Baptist Clinic | Fowler Family Center for Cancer Care

    Jonesboro, Arkansas, 72401

  • Freeman Health Systems

    Joplin, Missouri, 64804

  • Southeast Nebraska Hematology & Oncology Consultants, PC

    Lincoln, Nebraska, 68510

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Texas Oncology, PA

    McAllen, Texas, 78503

  • AMPM Research Clinic

    Miami, Florida, 33133

  • Lakes Research, LLC

    Miami Lakes, Florida, 33014

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Floyd Memorial Cancer Center of Indiana

    New Albany, Indiana, 47150

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Mid Florida Hematology and Oncology Centers

    Orange City, Florida, 32763

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • West Ky Hematology & Oncology Group, PSC

    Paducah, Kentucky, 42003

  • Oncology Specialists, SC

    Park Ridge, Illinois, 60068

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15232

  • Florida Cancer Research Institute

    Plantation, Florida, 33324

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Delta Oncology Associates

    Portsmouth, Virginia, 23704

  • Emad Ibrahim, MD, Inc.

    Redlands, California, 92373

  • Methodist Richardson Medical Center- Cancer Center

    Richardson, Texas, 75082

  • Compassionate Cancer Care Medical Group, Inc

    Riverside, California, 92501

  • Carolina Blood and Cancer Care

    Rock Hill, South Carolina, 29732

  • Swedish American Cancer Center

    Rockford, Illinois, 61114

  • Penobscot Bay Medical Center

    Rockport, Maine, 04856

  • Quest Research Institute

    Royal Oak, Michigan, 48073

  • St Joseph Heritage Healthcare Institution

    Santa Rosa, California, 95403

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Arizona Clinical Research Center/ ACRC

    Tucson, Arizona, 85715

  • Associates in Hematology and Oncology, PC

    Upland, Pennsylvania, 19013

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Wellness Oncology Hematology

    West Hills, California, 91307

  • Northern Indiana Cancer Research Consortium

    Westville, Indiana, 46391

  • Oncology Institute of Hope and Innovation

    Whittier, California, 90603

  • Bond Clinic, P.A.

    Winter Haven, Florida, 33881

  • Reliant Medical Group

    Worcester, Massachusetts, 01608v

  • Mercy Health Youngstown LLC DBA

    Youngstown, Ohio, 44504 44501

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

Canada3 sites

  • CISSS de la Montérégie-Centre

    Greenfield Park, Quebec, J4V 2H1

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • CHU de Quebec - Universite Laval

    Québec, Quebec, G1S 4L8

Other trials in Canada

South Korea2 sites

  • Cha Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496

  • Severance Hospital

    Sinchon-dong, Seoul, 03722

Other trials in South Korea

About this study

Official title: RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)

The purpose of this study was to compare the efficacy of a single dose 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) in Cycle 1.

Read the detailed description

This was a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 vs pegfilgrastim in participants with breast cancer treated with TC chemotherapy.

Each cycle was 21 days. Four cycles were evaluated in 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).

Being tested
SPI-2012, Pegfilgrastim, Docetaxel, Cyclophosphamide
Keywords
Neutropenia, Breast Cancer, Long-acting Myeloid Growth 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 Rolontis®, Eflapegrastim, (HM10460A)

    Single-use syringes for subcutaneous injection, administered on Day 2 of each cycle

  • PegfilgrastimDrug

    Also called Neulasta®

    Single-dose subcutaneous injection administered on Day 2 of each cycle

  • DocetaxelDrug

    Also called Taxotere

    Standard therapy

  • CyclophosphamideDrug

    Also called Cytoxan

    Standard therapy

Study groups in NCT02643420
Study groupRoleWhat they receive
Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)ExperimentalParticipants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor [G-CSF]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care.
Receives: Drug: SPI-2012; Drug: Docetaxel; Drug: Cyclophosphamide
Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)ExperimentalParticipants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m^2 IV infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care.
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/L), after the administration of study drug in Cycle 1.

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

Secondary outcomes (8)

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

    Time to ANC Recovery was defined as the time from chemotherapy administration until ANC increased to ≥1.5×10^9/L after the expected nadir within Cycle 1. Time to ANC recovery was assigned as 0 for participants whose ANC value never dropped below 1.5 x10^9/L.

    Measured: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

  2. Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1

    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 Days 4, 15 in Cycle 1 (each cycle was 21 days)

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

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

    Measured: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

  4. Duration of Severe Neutropenia in Cycle 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 an ANC below the threshold in Cycles 2, 3, and 4.

    Measured: Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 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 Days 4, 15 in Cycle 1 (each cycle was 21 days)

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

    FN was defined as an oral temperature > 38.3 degrees C (101.0 degrees Fahrenheit [F]) or two consecutive readings of >=38.0 degrees C (100.4 degrees 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 was 21 days)

  7. Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4

    RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and 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 to 4 (each cycle was 21 days)

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

    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 for Treatment Period is defined as adverse event with an onset date on or after the date of study drug administration through the end of treatment. TEAE for follow up is defined as any new onset or ongoing AE at the end of Treatment. 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: From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)

Timeline

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

  1. First posted31 Dec 2015 (estimated)
  2. Study start19 Jan 2016
  3. Primary completion24 Jan 2018
  4. Study completion31 Oct 2018

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
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02643420
Sponsor's protocol ID
SPI-GCF-301
Acronym
ADVANCE
Status last verified
Feb 2022
First submitted
29 Dec 2015
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 81 sites in 3 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 10 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 81 sites in United States, Canada, South Korea. 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 Days 4-15 in Cycle 1 (each cycle was 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 NCT02643420.

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.

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