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

NCT02643420 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SPI-GCF-301
• Study Type: interventional
• Target: 406
• Locations: 3 countries
• Sites: 81

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.

Conditions

Neutropenia; Breast Cancer

Keywords

Neutropenia; Breast Cancer; Long-acting Myeloid Growth Factor; Early Stage Breast Cancer; Docetaxel + Cyclophosphamide (TC) chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 and Days 4-15 in Cycle 1 (each cycle was 21 days)

Secondary Outcomes (8)

• Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1

  Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

• Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1

  Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

• Number of Participants With Febrile Neutropenia (FN) in Cycle 1

  Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

• Duration of Severe Neutropenia in Cycle 2, 3 and 4

  Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days)

• Number of Participants With Neutropenic Complications in Cycle 1

  Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

Study Arms (2)

Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)

EXPERIMENTAL

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.

Drug: SPI-2012; Drug: Docetaxel; Drug: Cyclophosphamide

Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

EXPERIMENTAL

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.

Drug: Pegfilgrastim; Drug: Docetaxel; Drug: Cyclophosphamide

Interventions

SPI-2012 DRUG

Single-use syringes for subcutaneous injection, administered on Day 2 of each cycle

Also known as: Rolontis®, Eflapegrastim, (HM10460A)

Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)

Pegfilgrastim DRUG

Single-dose subcutaneous injection administered on Day 2 of each cycle

Also known as: Neulasta®

Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

Docetaxel DRUG

Standard therapy

Also known as: Taxotere

Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC); Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

Cyclophosphamide DRUG

Standard therapy

Also known as: Cytoxan

Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC); Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (81)

Arizona Center for Cancer Care

Glendale, Arizona, 85306, United States

Location

Arizona Clinical Research Center/ ACRC

Tucson, Arizona, 85715, United States

Location

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

NEA Baptist Clinic | Fowler Family Center for Cancer Care

Jonesboro, Arkansas, 72401, United States

Location

Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States

Location

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Alta Bates Summit Medical Center

Berkeley, California, 94704, United States

Location

Precision Research Institute, LLC

Chula Vista, California, 91910, United States

Location

Compassionate Cancer Care Medical Group, Inc.

Corona, California, 92879, United States

Location

Compassionate Care Research Group, Inc.

Fountain Valley, California, 92708, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Ventura County Hematology-Oncology Specialists

Oxnard, California, 93030, United States

Location

Valley Medical Oncology Consultants

Pleasanton, California, 94588, United States

Location

Emad Ibrahim, MD, Inc.

Redlands, California, 92373, United States

Location

Compassionate Cancer Care Medical Group, Inc

Riverside, California, 92501, United States

Location

St Joseph Heritage Healthcare Institution

Santa Rosa, California, 95403, United States

Location

Wellness Oncology Hematology

West Hills, California, 91307, United States

Location

Oncology Institute of Hope and Innovation

Whittier, California, 90603, United States

Location

Omega Research Consultants LLC

DeBary, Florida, 32713, United States

Location

Pasco Pinellas Cancer Center

Holiday, Florida, 34691, United States

Location

AMPM Research Clinic

Miami, Florida, 33133, United States

Location

Lakes Research, LLC

Miami Lakes, Florida, 33014, United States

Location

Mid Florida Hematology and Oncology Centers

Orange City, Florida, 32763, United States

Location

Florida Cancer Research Institute

Plantation, Florida, 33324, United States

Location

Bond Clinic, P.A.

Winter Haven, Florida, 33881, United States

Location

John B Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Dwight D. Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Clintell, Inc/Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

Joliet Oncology Hematology Associates

Joliet, Illinois, 60435, United States

Location

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

Swedish American Cancer Center

Rockford, Illinois, 61114, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

Floyd Memorial Cancer Center of Indiana

New Albany, Indiana, 47150, United States

Location

Northern Indiana Cancer Research Consortium

Westville, Indiana, 46391, United States

Location

Ashland-Bellefonte Cancer Center

Ashland, Kentucky, 41101, United States

Location

West Ky Hematology & Oncology Group, PSC

Paducah, Kentucky, 42003, United States

Location

Pontchartrain Cancer Center

Covington, Louisiana, 70433, United States

Location

Highland Clinic

Shreveport, Louisiana, 71105, United States

Location

Penobscot Bay Medical Center

Rockport, Maine, 04856, United States

Location

RCCA MD LLC/The Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Reliant Medical Group

Worcester, Massachusetts, 01608v, United States

Location

Quest Research Institute

Royal Oak, Michigan, 48073, United States

Location

Forrest General Hospital

Hattiesburg, Mississippi, 39401, United States

Location

Freeman Health Systems

Joplin, Missouri, 64804, United States

Location

St. Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

Saint Francis Cancer Treatment Center

Grand Island, Nebraska, 68803, United States

Location

Southeast Nebraska Hematology & Oncology Consultants, PC

Lincoln, Nebraska, 68510, United States

Location

New Jersey Hematology Oncology Associates

Brick, New Jersey, 08724, United States

Location

North Shore Hematology Oncology Associates

East Setauket, New York, 11733, United States

Location

Waverly Hematology Oncology

Cary, North Carolina, 27518, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

The Lindner Research Center at the Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Mercy Health Youngstown LLC DBA

Youngstown, Ohio, 44504 44501, United States

Location

Good Samaritan Hospital Corvallis

Corvallis, Oregon, 97330, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15232, United States

Location

Associates in Hematology and Oncology, PC

Upland, Pennsylvania, 19013, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Bon Secours Saint Francis Cancer

Greenville, South Carolina, 29607, United States

Location

Carolina Blood and Cancer Care

Rock Hill, South Carolina, 29732, United States

Location

Cookeville Regional Medical Center

Cookeville, Tennessee, 38501, United States

Location

The West Clinic, PC, d/b/a West Cancer Center

Germantown, Tennessee, 38138, United States

Location

CHI St. Joseph Health Cancer Center

Bryan, Texas, 77802, United States

Location

Texas Oncology -Methodist Dallas Cancer Center

Dallas, Texas, 75203, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

Texas Oncology, PA

McAllen, Texas, 78503, United States

Location

Methodist Richardson Medical Center- Cancer Center

Richardson, Texas, 75082, United States

Location

Northern Utah Associates

Ogden, Utah, 84403, United States

Location

Delta Oncology Associates

Portsmouth, Virginia, 23704, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

CISSS de la Montérégie-Centre

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

CHU de Quebec - Universite Laval

Québec, Quebec, G1S 4L8, Canada

Location

Cha Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Severance Hospital

Sinchon-dong, Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Neutropenia; Breast Neoplasms

Interventions

eflapegrastim; pegfilgrastim; Docetaxel; Cyclophosphamide

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Shanta Chawla
• Organization: Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618

shanta.chawla@sppirx.com

(949) 788-6700

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: December 31, 2015
• Study Start: January 19, 2016
• Primary Completion: January 24, 2018
• Study Completion: October 31, 2018
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2); US (76); CA (3)