Clinical trial NCT02953340: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neutropenia
Breast Cancer
Keywords: Neutropenia
Breast Cancer
Long-acting Granulocyte Colony Stimulating Factor
Early Stage Breast Cancer
Docetaxel + Cyclophosphamide (TC) chemotherapy
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Duration of Severe Neutropenia (DSN) in Cycle 1
timeFrame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
Secondary outcomes:
measure: Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1
timeFrame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
measure: Depth of ANC Nadir in Cycle 1
timeFrame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
measure: Number of Participants With Febrile Neutropenia (FN) in Cycle 1
timeFrame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
measure: Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4
timeFrame: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
measure: Number of Participants With Neutropenic Complications in Cycle 1
timeFrame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
measure: Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4
timeFrame: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
measure: Relative Dose Intensity (RDI) of TC Chemotherapy
timeFrame: Cycles 1, 2, 3 and 4 (each cycle = 21 days)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
timeFrame: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: ACRC/ Arizona Clinical Research Center Inc.
state: Arizona
city: Yuma
country: United States
facility: Yuma Regional Cancer Center
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Baptist Clinic | Fowler Family Center for Cancer Care
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Fountain Valley
country: United States
facility: Compassionate Care Research Group, Inc.
state: California
city: Fresno
country: United States
facility: California Cancer Associates for Research and Excellence Inc.
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Palm Springs
country: United States
facility: Desert Regional Medical Center
state: California
city: Redlands
country: United States
facility: Emad Ibrahim, MD, INC.
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute/ The Oncology Institute of Hope and Innovation
state: California
city: Denver
country: United States
facility: Denver Health & Hospital Authority
state: Colorado
city: Holiday
country: United States
facility: Pasco Pinellas Cancer Center
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research, LLC
state: Florida
city: Orange City
country: United States
facility: Mid-Florida Hematology and Oncology Centers
state: Florida
city: Pembroke Pines
country: United States
facility: Millennium Oncology
state: Florida
city: Plantation
country: United States
facility: BRCR Medical Center Inc
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Hematology and Oncology
state: Florida
city: Winter Haven
country: United States
facility: Bond & Steele Clinic, PA.
state: Florida
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Dublin
country: United States
facility: Cancer Center of Middle Georgia
state: Georgia
city: Fort Gordon
country: United States
facility: Dwight D. Eisenhower Army Medical Center
state: Georgia
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
city: Park Ridge
country: United States
facility: Oncology Specialists, SC
state: Illinois
city: Indianapolis
country: United States
facility: FPN Oncology and Hematology Specialists
state: Indiana
city: Danville
country: United States
facility: Commonwealth Hematology-Oncology, PSC
state: Kentucky
city: Covington
country: United States
facility: Pontchartrain Cancer Center
state: Louisiana
city: Royal Oak
country: United States
facility: Quest Research Institute
state: Michigan
city: Saint Cloud
country: United States
facility: Coborn Cancer Center
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology
state: Mississippi
city: Joplin
country: United States
facility: Freeman Health Systems
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Grand Island
country: United States
facility: CHI Health St Francis, St Francis Cancer Treatment Center
state: Nebraska
city: Cary
country: United States
facility: Waverly Hematology Oncology
state: North Carolina
city: Gastonia
country: United States
facility: Gaston Hematology & Oncology Associates, PC
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center
state: Ohio
city: Youngstown
country: United States
facility: St. Elizabeth Youngstown Hospital JACBCC/Oncology/ Mercy Health Youngstown LLC
state: Ohio
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
city: Germantown
country: United States
facility: The West Clinic, PC, d/b/a West Cancer Center
state: Tennessee
city: Bryan
country: United States
facility: CHI St Joseph Health Cancer Center
state: Texas
city: Laredo
country: United States
facility: Envision Cancer Center, LLC
state: Texas
city: McAllen
country: United States
facility: Texas Oncology, PA- McAllen South 2nd Street
state: Texas
city: Tyler
country: United States
facility: HOPE Cancer Center of East Texas
state: Texas
city: Portsmouth
country: United States
facility: Delta Hematology/Oncology Associates
state: Virginia
city: Everett
country: United States
facility: Providence Regional Center Partnership
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Longueuil
country: Canada
facility: CISSS de la Montérégie-Centre
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
city: Budapest
country: Hungary
facility: Szent Imre Egyetemi Oktatokorhaz, Klinikai Onkologiai Osztaly
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet, ""B"" Belgyogyaszati Onkologiai Osztaly
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato Korhaz, Klinikai Onkologiai es Sugarterapias Centrum
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak, Egyetemi Oktato Korhaz, Onkoradiologiai Osztaly
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz, Klinikai Onkologiai Osztaly
city: Pune
country: India
facility: KEM Hospital Research Centre
state: Maharashtra
city: Vellore
country: India
facility: Christian Medical College
state: Tamil Nadu
city: Irwon-ro
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu Seoul
city: Ilsan-ro
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: IIsan-ro
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Yatap-ro
country: Korea, Republic of
facility: Cha Bundang Medical Center
state: Gyeonggi-do
city: Daehwa-ro
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu Seoul
city: Inhang-ro
country: Korea, Republic of
facility: Inha University Hospital
state: Jung-guIncheon
city: Inchon-ro
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbuk-guSeoul
city: Yonsei-ro
country: Korea, Republic of
facility: Severance Hospital
state: Seoul
city: Bialystok
country: Poland
facility: BIALOSTOCKIE CENTRUM ONKOLOGII im. Marii Sklodowskiej-Curie Oddzial Onkologii Klinicznej im. Ewy Pileckiej z Pododdzialem Chemioterapii dziennej
city: Grudziadz
country: Poland
facility: Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Oddział Onkologii Klinicznej
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki Klinika Chirurgii Onkologicznej i Chorob Piersi z Pododdzialem Onkologii Klinicznej
city: Poznan
country: Poland
facility: Pracownia Leku Cytotoksycznego Szpitala Klinicznego Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu
city: Racibórz
country: Poland
facility: Szpital Rejonowy im. Dr. Jozefa Rostka w Raciborzu Dzienny Oddzial Chemioterapii
city: Rzeszow
country: Poland
facility: MrukMed. Lekarz Beata Madej Mruk i Partner. Spolka Partnerska Oddzial nr 1 w Rzeszowie
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
Study officials:
References: