Skip to main content
OpenTrials
Completed

NCT Number: NCT02643420

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

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.

Completed

Looking for future studies?

Notify Me

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, Greenfield Park, Quebec, Canada

Loading trial locations.

About this study

This was a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 vs pegfilgrastim in participants with breast cancer treated with TC chemotherapy.

Each cycle was 21 days. Four cycles were evaluated in 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).

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 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

Key Exclusion Criteria:

  • 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

Treatment and study plan

SPI-2012

Drug

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

Other names: Rolontis®, Eflapegrastim, (HM10460A)

pegfilgrastim

Drug

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

Other names: Neulasta®

docetaxel

Drug

Standard therapy

Other names: Taxotere

Cyclophosphamide

Drug

Standard therapy

Other names: Cytoxan

Primary outcomes

  1. Duration of Severe Neutropenia (DSN) in Cycle 1

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

    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.

Secondary outcomes

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

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

    Time to ANC Recovery was defined as the time from chemotherapy administration until ANC increased to ≥1.5×10^9/L after the expected nadir within Cycle 1. Time to ANC recovery was assigned as 0 for participants whose ANC value never dropped below 1.5 x10^9/L.

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

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

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

    FN was defined as an oral temperature > 38.3 degrees Celsius (C) (101.0 degrees Fahrenheit [F]) or two consecutive readings of >=38.0 degrees C (100.4 degrees F) for 2 hours and ANC <1.0×10^9/L.

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

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

    DSN was defined as the number of days of severe neutropenia (ANC <0.5×10^9 /L) from the first occurrence of an ANC below the threshold in Cycles 2, 3, and 4.

  5. Number of Participants With Neutropenic Complications in Cycle 1

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

    FN was defined as an oral temperature > 38.3 degrees C (101.0 degrees Fahrenheit [F]) or two consecutive readings of >=38.0 degrees C (100.4 degrees F) for 2 hours and ANC <1.0×10^9/L.

  7. Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4

    Time frame: Cycles 1 to 4 (each cycle was 21 days)

    RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and 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)

    Time frame: From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 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 for Treatment Period is defined as adverse event with an onset date on or after the date of study drug administration through the end of treatment. TEAE for follow up is defined as any new onset or ongoing AE at the end of Treatment. 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.

Sponsors and collaborators

Lead sponsor

Spectrum Pharmaceuticals, Inc

Industry

Registry information

Official study title

RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)

Acronym: ADVANCE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 31, 2015
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.