Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

Neutropenia Clinical Trial

Official title:

Optimal Timing and Duration of Daily G-CSF With Adjuvant TAC Chemotherapy in Node-positive Breast Cancer;Multicenter, Randomized, Open Label, Clinically IV Phase

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01571518
• Other study ID #: 2011-91
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 29, 2012
• Last updated: April 3, 2012
• Start date: April 2012
• Est. completion date: October 2013

Study information

• Verified date: April 2012
• Source: Sunchonhang University
• Contact: Chul Wan Lim, M.D., Ph.D
• Phone: 82-32-621-5114
• Email: cylim[@]soonchunhyang.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

After resection of lymph node positive breast cancer, the injection duration and timing of Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.

Description:

The duration and the injection timing of G-CSF are effective in the prevention of neutropenia, incidence of infection and non hematologic toxicity. With the TAC chemotherapy after resection of breast cancer, the G-CSF early injection versus late injection could change the frequency of neutropenia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy

Exclusion Criteria:

• pregnancy,

• cardiovascualr disease,

• abnormal renal function,

• hematologic disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neutropenia

Intervention

Drug:
• late leukostim
injection of G-CSF (leukostim)5?/kg from day 5 of TAC chemotherapy
• early leukostim
injection of G-CSF (leukostim)5?/kg from day 2 of TAC chemotherapy

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang university Puchun Hospital	Puchun

Sponsors (2)

Lead Sponsor	Collaborator
Hyuk moon Kim	Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Chan A, Fu WH, Shih V, Coyuco JC, Tan SH, Ng R. Impact of colony-stimulating factors to reduce febrile neutropenic events in breast cancer patients receiving docetaxel plus cyclophosphamide chemotherapy. Support Care Cancer. 2011 Apr;19(4):497-504. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of neutropenia	during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)	Change from Baseline in neutrophil count at 21days	Yes