Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

Chemotherapy-induced Neutropenia Clinical Trial

— NEUGR-002  

Official title:

A Randomized Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837265
• Other study ID #: NEUGR-002
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 21, 2008
• Est. completion date: June 26, 2009

Study information

• Verified date: April 2024
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determination of the effect of balugrastim on the duration and severity of severe neutropenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: June 26, 2009
• Est. primary completion date: June 26, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel).

Exclusion Criteria:

• Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months).

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Neutropenia

Intervention

Biological:
• Balugrastim
Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.

Drug:
• Pegfilgrastim
Pegfilgrastim will be administered per dose and schedule specified in the arm description.
• Chemotherapy Regimen
The chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m^2) and docetaxel 75 mg/m^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Severe Neutropenia in Cycle 1	Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 x 10^9/liter [L]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC =0.5 x 10^9/L within the cycle.	Cycle 1 (cycle length = 21 days)
Secondary	Number of Participants With Febrile Neutropenia	Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and oral temperature =38.2 degrees celsius (°C) occurring on the same day. Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.	Cycles 1 to 4 (each cycle length = 21 days)
Secondary	Duration of Severe Neutropenia in Cycles 2, 3, and 4	Severe neutropenia was defined as Grade 4 neutropenia (ANC <0.5 x 10^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC =0.5 x 10^9/L within the cycle.	Cycles 2, 3, and 4 (each cycle length = 21 days)
Secondary	Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4	Time to ANC recovery was defined as the time from the nadir ANC to an ANC =1.5 x 10^9/L and was calculated for participants with ANC <1.5 x 10^9/L after the beginning of a chemotherapy cycle. Time to ANC recovery was calculated by cycle as the number of days from the nadir (the lowest ANC during a chemotherapy cycle) until a participant reached an ANC >1.5 x 10^9/L.	Cycles 1, 2, 3, and 4