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

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ClinicalTrials.gov Identifier: NCT02953340
Recruitment Status : Completed
First Posted : November 2, 2016
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Study Description
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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).

Condition or disease Intervention/treatment Phase
Neutropenia Breast Cancer Drug: SPI-2012 Drug: Pegfilgrastim Drug: Docetaxel Drug: Cyclophosphamide Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : May 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: (Arm 1): SPI-2012 and TC
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.
 Drug: SPI-2012
Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
Other Names:
  • HM10460A
  • Rolontis®
  • Eflapegrastim

Drug: Docetaxel
75mg/m^2 IV infusion administered on Day 1 of each cycle
Other Name: Taxotere

Drug: Cyclophosphamide
600mg/m^2 IV infusion administered on Day 1 of each cycle
Other Name: Cytoxan
Experimental: (Arm 2): Pegfilgrastim and TC
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.
 Drug: Pegfilgrastim
Subcutaneous injection administered on Day 2 of each cycle.
Other Name: Neulasta®

Drug: Docetaxel
75mg/m^2 IV infusion administered on Day 1 of each cycle
Other Name: Taxotere

Drug: Cyclophosphamide
600mg/m^2 IV infusion administered on Day 1 of each cycle
Other Name: Cytoxan


Outcome Measures
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Primary Outcome Measures :
  1. Duration of Severe Neutropenia (DSN) in Cycle 1 [ Time Frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) ]
    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 :
  1. Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 [ Time Frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) ]
    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.

  2. Depth of ANC Nadir in Cycle 1 [ Time Frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) ]
    The depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or pegfilgrastim) in Cycle 1.

  3. Number of Participants With Febrile Neutropenia (FN) in Cycle 1 [ Time Frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) ]
    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.

  4. Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4 [ Time Frame: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days) ]
    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.

  5. Number of Participants With Neutropenic Complications in Cycle 1 [ Time Frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) ]
    Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.

  6. Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4 [ Time Frame: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days) ]
    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.

  7. Relative Dose Intensity (RDI) of TC Chemotherapy [ Time Frame: Cycles 1, 2, 3 and 4 (each cycle = 21 days) ]
    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.

  8. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death [ Time Frame: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months) ]
    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.

  9. Number of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953340


Locations
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Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
  Study Documents (Full-Text)

Documents provided by Spectrum Pharmaceuticals, Inc:
Study Protocol  [PDF] July 28, 2017
Statistical Analysis Plan  [PDF] August 6, 2018

More Information
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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02953340    
Other Study ID Numbers: SPI-GCF-302
2016-003469-24 ( EudraCT Number )
First Posted: November 2, 2016    Key Record Dates
Results First Posted: March 2, 2022
Last Update Posted: March 2, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spectrum Pharmaceuticals, Inc:
Neutropenia
Breast Cancer
Long-acting Granulocyte Colony Stimulating Factor
Early Stage Breast Cancer
Docetaxel + Cyclophosphamide (TC) chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Cyclophosphamide
Docetaxel
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators