Back to resultsSPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) (ADVANCE)
Primary Purpose
Neutropenia, Breast Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SPI-2012
Pegfilgrastim
Docetaxel
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Neutropenia focused on measuring Neutropenia, Breast Cancer, Long-acting Myeloid Growth Factor, Early Stage Breast Cancer, Docetaxel + Cyclophosphamide (TC) chemotherapy
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
Sites / Locations
- Arizona Center for Cancer Care
- Arizona Clinical Research Center/ ACRC
- Yuma Regional Medical Center
- Genesis Cancer Center
- NEA Baptist Clinic | Fowler Family Center for Cancer Care
- Pacific Cancer Medical Center, Inc.
- CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
- Alta Bates Summit Medical Center
- Precision Research Institute, LLC
- Compassionate Cancer Care Medical Group, Inc.
- Compassionate Care Research Group, Inc.
- Long Beach Memorial Medical Center
- Pacific Shores Medical Group
- Ventura County Hematology-Oncology Specialists
- Valley Medical Oncology Consultants
- Emad Ibrahim, MD, Inc.
- Compassionate Cancer Care Medical Group, Inc
- St Joseph Heritage Healthcare Institution
- Wellness Oncology Hematology
- Oncology Institute of Hope and Innovation
- Omega Research Consultants LLC
- Pasco Pinellas Cancer Center
- Lakes Research, LLC
- AMPM Research Clinic
- Mid Florida Hematology and Oncology Centers
- Florida Cancer Research Institute
- Bond Clinic, P.A.
- John B Amos Cancer Center
- Dwight D. Eisenhower Army Medical Center
- Memorial Health University Medical Center
- Saint Alphonsus Regional Medical Center
- Clintell, Inc/Swedish Covenant Hospital
- Joliet Oncology Hematology Associates
- Oncology Specialists, SC
- Swedish American Cancer Center
- Carle Cancer Center
- Franciscan St. Francis Health
- Floyd Memorial Cancer Center of Indiana
- Northern Indiana Cancer Research Consortium
- Ashland-Bellefonte Cancer Center
- West Ky Hematology & Oncology Group, PSC
- Pontchartrain Cancer Center
- Highland Clinic
- Penobscot Bay Medical Center
- RCCA MD LLC/The Center for Cancer and Blood Disorders
- Reliant Medical Group
- Quest Research Institute
- Forrest General Hospital
- Freeman Health Systems
- St. Vincent Frontier Cancer Center
- Saint Francis Cancer Treatment Center
- Southeast Nebraska Hematology & Oncology Consultants, PC
- New Jersey Hematology Oncology Associates
- North Shore Hematology Oncology Associates
- Waverly Hematology Oncology
- Aultman Hospital
- Gabrail Cancer Center Research
- The Lindner Research Center at the Christ Hospital
- Mercy Health Youngstown LLC DBA
- Good Samaritan Hospital Corvallis
- University of Pittsburgh Medical Center (UPMC)
- Associates in Hematology and Oncology, PC
- AnMed Health Cancer Center
- Bon Secours Saint Francis Cancer
- Carolina Blood and Cancer Care
- Cookeville Regional Medical Center
- The West Clinic, PC, d/b/a West Cancer Center
- CHI St. Joseph Health Cancer Center
- Texas Oncology -Methodist Dallas Cancer Center
- Oncology Consultants
- Texas Oncology, PA
- Methodist Richardson Medical Center- Cancer Center
- Northern Utah Associates
- Delta Oncology Associates
- Northwest Medical Specialties, PLLC
- West Virginia University
- CISSS de la Montérégie-Centre
- Jewish General Hospital
- CHU de Quebec - Universite Laval
- Cha Bundang Medical Center
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)
Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02643420
First Posted
December 29, 2015
Last Updated
February 28, 2022
Sponsor
Spectrum Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT02643420
Brief Title
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
Acronym
ADVANCE
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2016 (Actual)
Primary Completion Date
January 24, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia, Breast Cancer
Keywords
Neutropenia, Breast Cancer, Long-acting Myeloid Growth Factor, Early Stage Breast Cancer, Docetaxel + Cyclophosphamide (TC) chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
406 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SPI-2012
Other Intervention Name(s)
Rolontis®, Eflapegrastim, (HM10460A)
Intervention Description
Single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Neulasta®
Intervention Description
Single-dose subcutaneous injection administered on Day 2 of each cycle
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Standard therapy
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
Standard therapy
Primary Outcome Measure Information:
Title
Duration of Severe Neutropenia (DSN) in Cycle 1
Description
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.
Time Frame
Day 1 and Days 4-15 in Cycle 1 (each cycle was 21 days)
Secondary Outcome Measure Information:
Title
Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1
Description
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.
Time Frame
Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
Title
Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1
Description
Depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or Pegfilgrastim) in Cycle 1.
Time Frame
Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
Title
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
Description
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.
Time Frame
Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
Title
Duration of Severe Neutropenia in Cycle 2, 3 and 4
Description
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.
Time Frame
Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days)
Title
Number of Participants With Neutropenic Complications in Cycle 1
Description
Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.
Time Frame
Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
Title
Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4
Description
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.
Time Frame
Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle was 21 days)
Title
Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4
Description
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.
Time Frame
Cycles 1 to 4 (each cycle was 21 days)
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Arizona Center for Cancer Care
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Clinical Research Center/ ACRC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Yuma Regional Medical Center
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
NEA Baptist Clinic | Fowler Family Center for Cancer Care
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Pacific Cancer Medical Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Precision Research Institute, LLC
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Compassionate Cancer Care Medical Group, Inc.
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Compassionate Care Research Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Ventura County Hematology-Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Valley Medical Oncology Consultants
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
Emad Ibrahim, MD, Inc.
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Compassionate Cancer Care Medical Group, Inc
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
St Joseph Heritage Healthcare Institution
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Wellness Oncology Hematology
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Omega Research Consultants LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Pasco Pinellas Cancer Center
City
Holiday
State/Province
Florida
ZIP/Postal Code
34691
Country
United States
Facility Name
Lakes Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
AMPM Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Mid Florida Hematology and Oncology Centers
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Florida Cancer Research Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Bond Clinic, P.A.
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33881
Country
United States
Facility Name
John B Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Dwight D. Eisenhower Army Medical Center
City
Fort Gordon
State/Province
Georgia
ZIP/Postal Code
30905
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Clintell, Inc/Swedish Covenant Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
Joliet Oncology Hematology Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Oncology Specialists, SC
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Swedish American Cancer Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Franciscan St. Francis Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Floyd Memorial Cancer Center of Indiana
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
Westville
State/Province
Indiana
ZIP/Postal Code
46391
Country
United States
Facility Name
Ashland-Bellefonte Cancer Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
West Ky Hematology & Oncology Group, PSC
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Pontchartrain Cancer Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Highland Clinic
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Penobscot Bay Medical Center
City
Rockport
State/Province
Maine
ZIP/Postal Code
04856
Country
United States
Facility Name
RCCA MD LLC/The Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Reliant Medical Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608v
Country
United States
Facility Name
Quest Research Institute
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Forrest General Hospital
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Freeman Health Systems
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Saint Francis Cancer Treatment Center
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Southeast Nebraska Hematology & Oncology Consultants, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
New Jersey Hematology Oncology Associates
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
North Shore Hematology Oncology Associates
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Waverly Hematology Oncology
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The Lindner Research Center at the Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Mercy Health Youngstown LLC DBA
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44504 44501
Country
United States
Facility Name
Good Samaritan Hospital Corvallis
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Associates in Hematology and Oncology, PC
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Bon Secours Saint Francis Cancer
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Carolina Blood and Cancer Care
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Cookeville Regional Medical Center
City
Cookeville
State/Province
Tennessee
ZIP/Postal Code
38501
Country
United States
Facility Name
The West Clinic, PC, d/b/a West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
CHI St. Joseph Health Cancer Center
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Texas Oncology -Methodist Dallas Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Methodist Richardson Medical Center- Cancer Center
City
Richardson
State/Province
Texas
ZIP/Postal Code
75082
Country
United States
Facility Name
Northern Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Delta Oncology Associates
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23704
Country
United States
Facility Name
Northwest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
CISSS de la Montérégie-Centre
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHU de Quebec - Universite Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Cha Bundang Medical Center
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Sinchon-dong
State/Province
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
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