Intermittent G-CSF in Patients With Breast Cancer Receiving Adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)

July 29, 2020 updated by: Sung-Bae Kim, Asan Medical Center

Intermittent Every Other Days of 5 Shot-filgrastim Compared With Single Pegfilgrastim in Breast Cancer Patients Receiving Adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide Chemotherapy (Intermittent G-CSF 105)

To compare the efficacy and safety of Day 2 (D2) once a cycle pegfilgrastim with Intermittent Every Other Days of 5 Shot (D3-11) filgrastim in early breast cancer patients treated with adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) regimen

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

According to manufacturers' recommendations (Amgen: Neupogenᵀᴹ), filgrastim are to start 24 hrs after the last dose of chemotherapy and continue until absolute neutrophil count (ANC) has recovered to within the normal range (or for 14 days). However, for economic and practical reasons and/or patient's convenience, it has been common practice to initiate filgrastim at a later days of cycle and/or administer a shorter course of treatment. Data from several clinical studies have shown that 10-11 days' filgrastim treatment is required for optimal prophylaxis for febrile neutropenia (FN), and data from other cancers shows that suboptimal use of G-CSFs could deteriorate clinical outcomes. However, in two recent randomized study with breast cancer patients undergoing TAC chemotherapy, acceptable incidence (7-18%) of FN was shown with the consecutive 6 or 7-daily filgrastim schemes. Also, although there is theoretical concern that there can be wide fluctuations in the patient's ANC over time in alternate or intermittent filgrastim administration, because there was no difference in clinical outcomes between daily- or intermittent-dose filgrastim schedules in previous literatures, the intermittent every other day of 5 shot-filgrastim scheme would have clinical outcomes comparable with previous consecutive 6 or 7-daily filgrastim schemes in coverage of ANC nadir. Therefore, it can be justified to investigate the non-inferiority of intermittent every other days of 5 shot-filgrastim scheme compared with control arm using of pegfilgrastim on D2.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The patients who underwent surgery for pathologically diagnosed early breast cancer (high risk stage II or stage III) or completely resected stage IV, and anticipated to undergo adjuvant chemotherapy with TAC regimen (docetaxel, doxorubicin, and cyclophosphamide)
  • The patients satisfying laboratory findings below before the enrollment of clinical trials: A. Absolute Neutrophil Count(ANC) ≥ 1,500/mm³; B. Platelet Count ≥ 100,000/mm³; C. Adequate renal functions (Cr < 1.5 X ULN); and D. Adequate liver function (Bilirubin < 1.5 X ULN, AST/ALT < 2.5 X ULN)
  • ECOG Performance status: 0-1
  • Cardiac ejection fraction ≥ 50% as measured by MUGA or 2D echocardiography without clinically significant abnormalities
  • Voluntarily participated in this study, and written informed consent of the patient

Exclusion Criteria:

  • Past history of immunotherapy or chemotherapy
  • Past history of autologous stem cell transplantation or bone marrow transplantation
  • The patient undergone radiation therapy within 4 weeks after written informed consent
  • Patient with any other concurrent malignancies or who are currently cured with past history within 5 years (excluding completely resected stage I early skin cancer)
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • Other serious illness or medical conditions inadequate to chemotherapy: A. Unstable cardiac disease (i.e. congestive heart failure, arrhythmia, symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry; B. History of significant neurological or psychiatric disorders including dementia or seizures; Active uncontrolled infection (viral, bacterial or fungal infection); and D. Other serious medical illnesses
  • Known hypersensitivity to any of the study drugs or its ingredients
  • Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
  • Past history of usage of granulocyte-colony stimulating factors
  • Patients with a known history of HIV (+) or HCV (+). However, HBV(+) patients who undergo primary prophylaxis are eligible.
  • Other serious illness or medical conditions determined by investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A. Pegfilgrastim
D2 once a cycle pegfilgrastim arm
Drug: Peg-filgrastim
Pegfilgrastim (Neulastaᵀᴹ) is administered at the D2 of each cycle. A dose of 6mg once a cycle is administered S.C., 24 (± 2) hours after completion of chemotherapy.
Other Names:
  • Neulastaᵀᴹ pfs inj. 6mg/0.6ml
Experimental: B. Filgrastim
Intermittent Every Other Days of 5 Shot (D3-11) filgrastim arm
Drug: Filgrastim
Filgrastim (Gracinᵀᴹ) is administered at the D3, D5, D7, D9, and D11 of each cycle. A dose of 5 μg/kg/day filgrastim is administered S.C. either as a bolus injection or as a continuous injection. Administer into the outer upper arm, abdomen (except within 2 inches of navel), front middle thigh, or the upper outer buttocks area.
Other Names:
  • Grasinᵀᴹ pfs inj.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of febrile neutropenia
Time Frame: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Measured at the completion of cycle 3
through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of febrile neutropenia at each cycle
Time Frame: At each cycle 1, 2, and 3 (each cycle is 21 days)
Measured at the completion of each cycle 1, 2, and 3
At each cycle 1, 2, and 3 (each cycle is 21 days)
Rates of anti-microbial use
Time Frame: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Measured at the completion of cycle 3
through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Duration of anti-microbial use
Time Frame: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Measured at the completion of cycle 3
through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Cumulative dose of chemotherapeutic agents
Time Frame: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Measured at the completion of cycle 3
through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Delay rate of next chemotherapy cycle due to inadequate neutrophil recovery
Time Frame: At each cycle 1, 2, and 3 (each cycle is 21 days)
Measured at the completion of each cycle 1, 2, and 3
At each cycle 1, 2, and 3 (each cycle is 21 days)
Duration of delay of next chemotherapy cycle due to inadequate neutrophil recovery
Time Frame: At each cycle 1, 2, and 3 (each cycle is 21 days)
Measured at the completion of each cycle 1, 2, and 3
At each cycle 1, 2, and 3 (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Kyowa Kirin Co., Ltd.

Investigators

  • Principal Investigator: Sung-Bae Kim, Ph.D., Department of Oncology, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 13, 2016

First Posted (Estimate)

February 18, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC 2015-1143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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