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

Primary Purpose

Neutropenia, Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SPI-2012
Pegfilgrastim
Docetaxel
Cyclophosphamide
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neutropenia focused on measuring Neutropenia, Breast Cancer, Long-acting Granulocyte Colony Stimulating Factor, Early Stage Breast Cancer, Docetaxel + Cyclophosphamide (TC) chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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
  • 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

Key Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • ACRC/ Arizona Clinical Research Center Inc.
  • Yuma Regional Cancer Center
  • Genesis Cancer Center
  • NEA Baptist Clinic | Fowler Family Center for Cancer Care
  • Pacific Cancer Medical Center, Inc.
  • Compassionate Care Research Group, Inc.
  • California Cancer Associates for Research and Excellence Inc.
  • Pacific Shores Medical Group
  • Los Angeles Hematology Oncology Medical Group
  • Desert Regional Medical Center
  • Emad Ibrahim, MD, INC.
  • Innovative Clinical Research Institute/ The Oncology Institute of Hope and Innovation
  • Denver Health & Hospital Authority
  • Pasco Pinellas Cancer Center
  • Lakes Research, LLC
  • Mid-Florida Hematology and Oncology Centers
  • Millennium Oncology
  • BRCR Medical Center Inc
  • Pinellas Hematology and Oncology
  • Bond & Steele Clinic, PA.
  • John B. Amos Cancer Center
  • Cancer Center of Middle Georgia
  • Dwight D. Eisenhower Army Medical Center
  • Saint Alphonsus Regional Medical Center
  • Oncology Specialists, SC
  • FPN Oncology and Hematology Specialists
  • Commonwealth Hematology-Oncology, PSC
  • Pontchartrain Cancer Center
  • Quest Research Institute
  • Coborn Cancer Center
  • Hattiesburg Clinic Hematology/Oncology
  • Freeman Health Systems
  • St. Vincent Frontier Cancer Center
  • CHI Health St Francis, St Francis Cancer Treatment Center
  • Waverly Hematology Oncology
  • Gaston Hematology & Oncology Associates, PC
  • Aultman Hospital
  • The Christ Hospital Cancer Center
  • St. Elizabeth Youngstown Hospital JACBCC/Oncology/ Mercy Health Youngstown LLC
  • Carolina Blood and Cancer Care Associates
  • The West Clinic, PC, d/b/a West Cancer Center
  • CHI St Joseph Health Cancer Center
  • Envision Cancer Center, LLC
  • Texas Oncology, PA- McAllen South 2nd Street
  • HOPE Cancer Center of East Texas
  • Delta Hematology/Oncology Associates
  • Providence Regional Center Partnership
  • Northwest Medical Specialties, PLLC
  • West Virginia University
  • CISSS de la Montérégie-Centre
  • Jewish General Hospital
  • Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
  • Szent Imre Egyetemi Oktatokorhaz, Klinikai Onkologiai Osztaly
  • Orszagos Onkologiai Intezet, ""B"" Belgyogyaszati Onkologiai Osztaly
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato Korhaz, Klinikai Onkologiai es Sugarterapias Centrum
  • Szabolcs-Szatmar-Bereg Megyei Korhazak, Egyetemi Oktato Korhaz, Onkoradiologiai Osztaly
  • Tolna Megyei Balassa Janos Korhaz, Klinikai Onkologiai Osztaly
  • KEM Hospital Research Centre
  • Christian Medical College
  • Samsung Medical Center
  • Wonju Severance Christian Hospital
  • National Cancer Center
  • Cha Bundang Medical Center
  • Seoul National University Hospital
  • Inha University Hospital
  • Korea University Anam Hospital
  • Severance Hospital
  • BIALOSTOCKIE CENTRUM ONKOLOGII im. Marii Sklodowskiej-Curie Oddzial Onkologii Klinicznej im. Ewy Pileckiej z Pododdzialem Chemioterapii dziennej
  • Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Oddział Onkologii Klinicznej
  • Instytut Centrum Zdrowia Matki Polki Klinika Chirurgii Onkologicznej i Chorob Piersi z Pododdzialem Onkologii Klinicznej
  • Pracownia Leku Cytotoksycznego Szpitala Klinicznego Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu
  • Szpital Rejonowy im. Dr. Jozefa Rostka w Raciborzu Dzienny Oddzial Chemioterapii
  • MrukMed. Lekarz Beata Madej Mruk i Partner. Spolka Partnerska Oddzial nr 1 w Rzeszowie
  • Zachodniopomorskie Centrum Onkologii Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

(Arm 1): SPI-2012 and TC

(Arm 2): Pegfilgrastim and TC

Arm Description

At 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.

At 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.

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 per liter [L]) from the first occurrence of ANC below the threshold.

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 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.
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.
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.
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.
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°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.
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.
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.
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.

Full Information

First Posted
October 27, 2016
Last Updated
February 28, 2022
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02953340
Brief Title
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
June 8, 2018 (Actual)
Study Completion Date
May 6, 2019 (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 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).
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.

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 Granulocyte Colony Stimulating 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
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(Arm 1): SPI-2012 and TC
Arm Type
Experimental
Arm Description
At 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.
Arm Title
(Arm 2): Pegfilgrastim and TC
Arm Type
Experimental
Arm Description
At 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.
Intervention Type
Drug
Intervention Name(s)
SPI-2012
Other Intervention Name(s)
HM10460A, Rolontis®, Eflapegrastim
Intervention Description
Supplied in prefilled 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
Subcutaneous injection administered on Day 2 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
75mg/m^2 IV infusion administered on Day 1 of each cycle
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
600mg/m^2 IV infusion administered on Day 1 of each cycle
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 per liter [L]) from the first occurrence of ANC below the threshold.
Time Frame
Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 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 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.
Time Frame
Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
Title
Depth of ANC Nadir in Cycle 1
Description
The 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 daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
Title
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
Description
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.
Time Frame
Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
Title
Duration of Severe Neutropenia (DSN) in Cycles 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 ANC below the threshold.
Time Frame
Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 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 daily on Days 4-15 in Cycle 1 (each cycle = 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°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.
Time Frame
Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
Title
Relative Dose Intensity (RDI) of TC Chemotherapy
Description
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.
Time Frame
Cycles 1, 2, 3 and 4 (each cycle = 21 days)
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
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 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.
Time Frame
Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
Title
Number of Participants With Clinically Significant Laboratory Abnormalities
Description
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.
Time Frame
Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 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 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 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 Key Exclusion Criteria: 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 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
Facility Information:
Facility Name
ACRC/ Arizona Clinical Research Center Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Yuma Regional Cancer 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
Compassionate Care Research Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
California Cancer Associates for Research and Excellence Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Los Angeles Hematology Oncology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Desert Regional Medical Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Emad Ibrahim, MD, INC.
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Innovative Clinical Research Institute/ The Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Denver Health & Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
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
Mid-Florida Hematology and Oncology Centers
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Millennium Oncology
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
BRCR Medical Center Inc
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Pinellas Hematology and Oncology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Bond & Steele Clinic, PA.
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Cancer Center of Middle Georgia
City
Dublin
State/Province
Georgia
ZIP/Postal Code
31021
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
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Oncology Specialists, SC
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
FPN Oncology and Hematology Specialists
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Commonwealth Hematology-Oncology, PSC
City
Danville
State/Province
Kentucky
ZIP/Postal Code
40422
Country
United States
Facility Name
Pontchartrain Cancer Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Quest Research Institute
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Coborn Cancer Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Hattiesburg Clinic Hematology/Oncology
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
CHI Health St Francis, St Francis Cancer Treatment Center
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Waverly Hematology Oncology
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Gaston Hematology & Oncology Associates, PC
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
The Christ Hospital Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
St. Elizabeth Youngstown Hospital JACBCC/Oncology/ Mercy Health Youngstown LLC
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Carolina Blood and Cancer Care Associates
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
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
Envision Cancer Center, LLC
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Texas Oncology, PA- McAllen South 2nd Street
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
HOPE Cancer Center of East Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Delta Hematology/Oncology Associates
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23704
Country
United States
Facility Name
Providence Regional Center Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
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
Longueuil
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
Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Szent Imre Egyetemi Oktatokorhaz, Klinikai Onkologiai Osztaly
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet, ""B"" Belgyogyaszati Onkologiai Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato Korhaz, Klinikai Onkologiai es Sugarterapias Centrum
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak, Egyetemi Oktato Korhaz, Onkoradiologiai Osztaly
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Tolna Megyei Balassa Janos Korhaz, Klinikai Onkologiai Osztaly
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
KEM Hospital Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
Christian Medical College
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Samsung Medical Center
City
Irwon-ro
State/Province
Gangnam-gu Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Ilsan-ro
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
National Cancer Center
City
IIsan-ro
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Cha Bundang Medical Center
City
Yatap-ro
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Daehwa-ro
State/Province
Jongno-gu Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Inhang-ro
State/Province
Jung-guIncheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Inchon-ro
State/Province
Seongbuk-guSeoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Yonsei-ro
State/Province
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
BIALOSTOCKIE CENTRUM ONKOLOGII im. Marii Sklodowskiej-Curie Oddzial Onkologii Klinicznej im. Ewy Pileckiej z Pododdzialem Chemioterapii dziennej
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Oddział Onkologii Klinicznej
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Instytut Centrum Zdrowia Matki Polki Klinika Chirurgii Onkologicznej i Chorob Piersi z Pododdzialem Onkologii Klinicznej
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Pracownia Leku Cytotoksycznego Szpitala Klinicznego Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Szpital Rejonowy im. Dr. Jozefa Rostka w Raciborzu Dzienny Oddzial Chemioterapii
City
Racibórz
ZIP/Postal Code
47-400
Country
Poland
Facility Name
MrukMed. Lekarz Beata Madej Mruk i Partner. Spolka Partnerska Oddzial nr 1 w Rzeszowie
City
Rzeszow
ZIP/Postal Code
35-021
Country
Poland
Facility Name
Zachodniopomorskie Centrum Onkologii Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
City
Szczecin
ZIP/Postal Code
71-730
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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