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Completed

NCT Number: NCT02953340

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CISSS de la Montérégie-Centre, Longueuil, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPI-2012

Drug

Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle

Other names: HM10460A, Rolontis®, Eflapegrastim

pegfilgrastim

Drug

Subcutaneous injection administered on Day 2 of each cycle.

Other names: Neulasta®

docetaxel

Drug

75mg/m^2 IV infusion administered on Day 1 of each cycle

Other names: Taxotere

Cyclophosphamide

Drug

600mg/m^2 IV infusion administered on Day 1 of each cycle

Other names: Cytoxan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Spectrum Pharmaceuticals, Inc

Industry

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 2, 2016
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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