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

NCT02685111 | Terminated Phase 2

• 1 other identifier: AMC 2015-1143
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Neutropenia; Febrile Neutropenia

Keywords

Breast cancer; Adjuvant; Docetaxel; Adriamycin; Cyclophosphamide; Neutropenia; Filgrastim; Pegfilgrastim

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of febrile neutropenia

  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 Outcomes (6)

• Incidence of febrile neutropenia at each cycle

  At each cycle 1, 2, and 3 (each cycle is 21 days)

• Rates of anti-microbial use

  through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks

• Duration of anti-microbial use

  through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks

• Cumulative dose of chemotherapeutic agents

  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

  At each cycle 1, 2, and 3 (each cycle is 21 days)

Study Arms (2)

A. Pegfilgrastim

ACTIVE COMPARATOR

D2 once a cycle pegfilgrastim arm

Drug: Peg-filgrastim

B. Filgrastim

EXPERIMENTAL

Intermittent Every Other Days of 5 Shot (D3-11) filgrastim arm

Drug: Filgrastim

Interventions

Filgrastim DRUG

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.

Also known as: Grasinᵀᴹ pfs inj.

B. Filgrastim

Peg-filgrastim DRUG

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.

Also known as: Neulastaᵀᴹ pfs inj. 6mg/0.6ml

A. Pegfilgrastim

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Kyowa Kirin Co., Ltd.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-746, South Korea

Location

Related Publications (9)

• Scott SD, Chrischilles EA, Link BK, Delgado DJ, Fridman M, Stolshek BS. Days of prophylactic filgrastim use to reduce febrile neutropenia in patients with non-Hodgkin's lymphoma treated with chemotherapy. J Manag Care Pharm. 2003 Mar-Apr;9(2 Suppl):15-21. doi: 10.18553/jmcp.2003.9.s2.15.

  PMID: 14613340 BACKGROUND

• von Minckwitz G, Raab G, Caputo A, Schutte M, Hilfrich J, Blohmer JU, Gerber B, Costa SD, Merkle E, Eidtmann H, Lampe D, Jackisch C, du Bois A, Kaufmann M. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol. 2005 Apr 20;23(12):2676-85. doi: 10.1200/JCO.2005.05.078.

  PMID: 15837982 BACKGROUND

• Weycker D, Hackett J, Edelsberg JS, Oster G, Glass AG. Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization? Ann Pharmacother. 2006 Mar;40(3):402-7. doi: 10.1345/aph.1G516. Epub 2006 Feb 21.

  PMID: 16492793 BACKGROUND

• Holmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002 Jun;13(6):903-9. doi: 10.1093/annonc/mdf130.

  PMID: 12123336 BACKGROUND

• Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003 Jan;14(1):29-35. doi: 10.1093/annonc/mdg019.

  PMID: 12488289 BACKGROUND

• Koumakis G, Vassilomanolakis M, Barbounis V, Hatzichristou E, Demiri S, Plataniotis G, Pamouktsoglou F, Efremidis AP. Optimal timing (Preemptive versus supportive) of granulocyte colony-stimulating factor administration following high-dose cyclophosphamide. Oncology. 1999;56(1):28-35. doi: 10.1159/000011926.

  PMID: 9885374 BACKGROUND

• Martin M, Lluch A, Segui MA, Ruiz A, Ramos M, Adrover E, Rodriguez-Lescure A, Grosse R, Calvo L, Fernandez-Chacon C, Roset M, Anton A, Isla D, del Prado PM, Iglesias L, Zaluski J, Arcusa A, Lopez-Vega JM, Munoz M, Mel JR. Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Ann Oncol. 2006 Aug;17(8):1205-12. doi: 10.1093/annonc/mdl135. Epub 2006 Jun 9.

  PMID: 16766587 BACKGROUND

• von Minckwitz G, Kummel S, du Bois A, Eiermann W, Eidtmann H, Gerber B, Hilfrich J, Huober J, Costa SD, Jackisch C, Grasshoff ST, Vescia S, Skacel T, Loibl S, Mehta KM, Kaufmann M; German Breast Group. Pegfilgrastim +/- ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study. Ann Oncol. 2008 Feb;19(2):292-8. doi: 10.1093/annonc/mdm438. Epub 2007 Sep 9.

  PMID: 17846019 BACKGROUND

• Papaldo P, Lopez M, Marolla P, Cortesi E, Antimi M, Terzoli E, Vici P, Barone C, Ferretti G, Di Cosimo S, Carlini P, Nistico C, Conti F, Di Lauro L, Botti C, Di Filippo F, Fabi A, Giannarelli D, Calabresi F. Impact of five prophylactic filgrastim schedules on hematologic toxicity in early breast cancer patients treated with epirubicin and cyclophosphamide. J Clin Oncol. 2005 Oct 1;23(28):6908-18. doi: 10.1200/JCO.2005.03.099. Epub 2005 Aug 29.

  PMID: 16129844 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia; Febrile Neutropenia

Interventions

Filgrastim; pegfilgrastim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Sung-Bae Kim, Ph.D.

  Department of Oncology, Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 18, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

KR (1)