SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
NCT ID: NCT02643420
Last Updated: 2022-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
406 participants
INTERVENTIONAL
2016-01-19
2018-10-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)
Participants 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.
SPI-2012
Single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
Docetaxel
Standard therapy
Cyclophosphamide
Standard therapy
Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)
Participants 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.
Pegfilgrastim
Single-dose subcutaneous injection administered on Day 2 of each cycle
Docetaxel
Standard therapy
Cyclophosphamide
Standard therapy
Interventions
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SPI-2012
Single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
Pegfilgrastim
Single-dose subcutaneous injection administered on Day 2 of each cycle
Docetaxel
Standard therapy
Cyclophosphamide
Standard therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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Arizona Center for Cancer Care
Glendale, Arizona, United States
Arizona Clinical Research Center/ ACRC
Tucson, Arizona, United States
Yuma Regional Medical Center
Yuma, Arizona, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
NEA Baptist Clinic | Fowler Family Center for Cancer Care
Jonesboro, Arkansas, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
Precision Research Institute, LLC
Chula Vista, California, United States
Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States
Compassionate Care Research Group, Inc.
Fountain Valley, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
Emad Ibrahim, MD, Inc.
Redlands, California, United States
Compassionate Cancer Care Medical Group, Inc
Riverside, California, United States
St Joseph Heritage Healthcare Institution
Santa Rosa, California, United States
Wellness Oncology Hematology
West Hills, California, United States
Oncology Institute of Hope and Innovation
Whittier, California, United States
Omega Research Consultants LLC
DeBary, Florida, United States
Pasco Pinellas Cancer Center
Holiday, Florida, United States
AMPM Research Clinic
Miami, Florida, United States
Lakes Research, LLC
Miami Lakes, Florida, United States
Mid Florida Hematology and Oncology Centers
Orange City, Florida, United States
Florida Cancer Research Institute
Plantation, Florida, United States
Bond Clinic, P.A.
Winter Haven, Florida, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Dwight D. Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Clintell, Inc/Swedish Covenant Hospital
Chicago, Illinois, United States
Joliet Oncology Hematology Associates
Joliet, Illinois, United States
Oncology Specialists, SC
Park Ridge, Illinois, United States
Swedish American Cancer Center
Rockford, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
Floyd Memorial Cancer Center of Indiana
New Albany, Indiana, United States
Northern Indiana Cancer Research Consortium
Westville, Indiana, United States
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, United States
West Ky Hematology & Oncology Group, PSC
Paducah, Kentucky, United States
Pontchartrain Cancer Center
Covington, Louisiana, United States
Highland Clinic
Shreveport, Louisiana, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
RCCA MD LLC/The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Reliant Medical Group
Worcester, Massachusetts, United States
Quest Research Institute
Royal Oak, Michigan, United States
Forrest General Hospital
Hattiesburg, Mississippi, United States
Freeman Health Systems
Joplin, Missouri, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Saint Francis Cancer Treatment Center
Grand Island, Nebraska, United States
Southeast Nebraska Hematology & Oncology Consultants, PC
Lincoln, Nebraska, United States
New Jersey Hematology Oncology Associates
Brick, New Jersey, United States
North Shore Hematology Oncology Associates
East Setauket, New York, United States
Waverly Hematology Oncology
Cary, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
The Lindner Research Center at the Christ Hospital
Cincinnati, Ohio, United States
Mercy Health Youngstown LLC DBA
Youngstown, Ohio, United States
Good Samaritan Hospital Corvallis
Corvallis, Oregon, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Associates in Hematology and Oncology, PC
Upland, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Bon Secours Saint Francis Cancer
Greenville, South Carolina, United States
Carolina Blood and Cancer Care
Rock Hill, South Carolina, United States
Cookeville Regional Medical Center
Cookeville, Tennessee, United States
The West Clinic, PC, d/b/a West Cancer Center
Germantown, Tennessee, United States
CHI St. Joseph Health Cancer Center
Bryan, Texas, United States
Texas Oncology -Methodist Dallas Cancer Center
Dallas, Texas, United States
Oncology Consultants
Houston, Texas, United States
Texas Oncology, PA
McAllen, Texas, United States
Methodist Richardson Medical Center- Cancer Center
Richardson, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
Delta Oncology Associates
Portsmouth, Virginia, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
CISSS de la Montérégie-Centre
Greenfield Park, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Quebec - Universite Laval
Québec, Quebec, Canada
Cha Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Severance Hospital
Sinchon-dong, Seoul, South Korea
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SPI-GCF-301
Identifier Type: -
Identifier Source: org_study_id
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