Breast Cancer Clinical Trial

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

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.

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Full 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).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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
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

Key Exclusion Criteria:

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
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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

406

Study ID:

NCT02643420

Recruitment Status:

Completed

Sponsor:

Spectrum Pharmaceuticals, Inc

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There are 81 Locations for this study

See Locations Near You

Arizona Center for Cancer Care
Glendale Arizona, 85306, United States
Arizona Clinical Research Center/ ACRC
Tucson Arizona, 85715, United States
Yuma Regional Medical Center
Yuma Arizona, 85364, United States
Genesis Cancer Center
Hot Springs Arkansas, 71913, United States
NEA Baptist Clinic | Fowler Family Center for Cancer Care
Jonesboro Arkansas, 72401, United States
Pacific Cancer Medical Center, Inc.
Anaheim California, 92801, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
Alta Bates Summit Medical Center
Berkeley California, 94704, United States
Precision Research Institute, LLC
Chula Vista California, 91910, United States
Compassionate Cancer Care Medical Group, Inc.
Corona California, 92879, United States
Compassionate Care Research Group, Inc.
Fountain Valley California, 92708, United States
Long Beach Memorial Medical Center
Long Beach California, 90806, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
Ventura County Hematology-Oncology Specialists
Oxnard California, 93030, United States
Valley Medical Oncology Consultants
Pleasanton California, 94588, United States
Emad Ibrahim, MD, Inc.
Redlands California, 92373, United States
Compassionate Cancer Care Medical Group, Inc
Riverside California, 92501, United States
St Joseph Heritage Healthcare Institution
Santa Rosa California, 95403, United States
Wellness Oncology Hematology
West Hills California, 91307, United States
Oncology Institute of Hope and Innovation
Whittier California, 90603, United States
Omega Research Consultants LLC
DeBary Florida, 32713, United States
Pasco Pinellas Cancer Center
Holiday Florida, 34691, United States
Lakes Research, LLC
Miami Lakes Florida, 33014, United States
AMPM Research Clinic
Miami Florida, 33133, United States
Mid Florida Hematology and Oncology Centers
Orange City Florida, 32763, United States
Florida Cancer Research Institute
Plantation Florida, 33324, United States
Bond Clinic, P.A.
Winter Haven Florida, 33881, United States
John B Amos Cancer Center
Columbus Georgia, 31904, United States
Dwight D. Eisenhower Army Medical Center
Fort Gordon Georgia, 30905, United States
Memorial Health University Medical Center
Savannah Georgia, 31404, United States
Saint Alphonsus Regional Medical Center
Boise Idaho, 83706, United States
Clintell, Inc/Swedish Covenant Hospital
Chicago Illinois, 60625, United States
Joliet Oncology Hematology Associates
Joliet Illinois, 60435, United States
Oncology Specialists, SC
Park Ridge Illinois, 60068, United States
Swedish American Cancer Center
Rockford Illinois, 61114, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Franciscan St. Francis Health
Indianapolis Indiana, 46237, United States
Floyd Memorial Cancer Center of Indiana
New Albany Indiana, 47150, United States
Northern Indiana Cancer Research Consortium
Westville Indiana, 46391, United States
Ashland-Bellefonte Cancer Center
Ashland Kentucky, 41101, United States
West Ky Hematology & Oncology Group, PSC
Paducah Kentucky, 42003, United States
Pontchartrain Cancer Center
Covington Louisiana, 70433, United States
Highland Clinic
Shreveport Louisiana, 71105, United States
Penobscot Bay Medical Center
Rockport Maine, 04856, United States
RCCA MD LLC/The Center for Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Reliant Medical Group
Worcester Massachusetts, 01608, United States
Quest Research Institute
Royal Oak Michigan, 48073, United States
Forrest General Hospital
Hattiesburg Mississippi, 39401, United States
Freeman Health Systems
Joplin Missouri, 64804, United States
St. Vincent Frontier Cancer Center
Billings Montana, 59102, United States
Saint Francis Cancer Treatment Center
Grand Island Nebraska, 68803, United States
Southeast Nebraska Hematology & Oncology Consultants, PC
Lincoln Nebraska, 68510, United States
New Jersey Hematology Oncology Associates
Brick New Jersey, 08724, United States
North Shore Hematology Oncology Associates
East Setauket New York, 11733, United States
Waverly Hematology Oncology
Cary North Carolina, 27518, United States
Aultman Hospital
Canton Ohio, 44710, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
The Lindner Research Center at the Christ Hospital
Cincinnati Ohio, 45219, United States
Mercy Health Youngstown LLC DBA
Youngstown Ohio, 44504, United States
Good Samaritan Hospital Corvallis
Corvallis Oregon, 97330, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh Pennsylvania, 15232, United States
Associates in Hematology and Oncology, PC
Upland Pennsylvania, 19013, United States
AnMed Health Cancer Center
Anderson South Carolina, 29621, United States
Bon Secours Saint Francis Cancer
Greenville South Carolina, 29607, United States
Carolina Blood and Cancer Care
Rock Hill South Carolina, 29732, United States
Cookeville Regional Medical Center
Cookeville Tennessee, 38501, United States
The West Clinic, PC, d/b/a West Cancer Center
Germantown Tennessee, 38138, United States
CHI St. Joseph Health Cancer Center
Bryan Texas, 77802, United States
Texas Oncology -Methodist Dallas Cancer Center
Dallas Texas, 75203, United States
Oncology Consultants
Houston Texas, 77030, United States
Texas Oncology, PA
McAllen Texas, 78503, United States
Methodist Richardson Medical Center- Cancer Center
Richardson Texas, 75082, United States
Northern Utah Associates
Ogden Utah, 84403, United States
Delta Oncology Associates
Portsmouth Virginia, 23704, United States
Northwest Medical Specialties, PLLC
Tacoma Washington, 98405, United States
West Virginia University
Morgantown West Virginia, 26506, United States
CISSS de la Montérégie-Centre
Greenfield Park Quebec, J4V 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
CHU de Quebec - Universite Laval
Québec Quebec, G1S 4, Canada
Cha Bundang Medical Center
Seongnam-si Gyeonggi-do, 13496, Korea, Republic of
Severance Hospital
Sinchon-dong Seoul, 03722, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

406

Study ID:

NCT02643420

Recruitment Status:

Completed

Sponsor:


Spectrum Pharmaceuticals, Inc

How clear is this clinincal trial information?

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