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

Study Overview
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Brief Summary
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Determination of the effect of balugrastim on the duration and severity of severe neutropenia.

Official Title
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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)

Conditions
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Chemotherapy-induced Neutropenia

Intervention / Treatment
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* Biological: Balugrastim
* Drug: Pegfilgrastim
* Drug: Chemotherapy Regimen


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot Phase: Balugrastim Low Dose<br>Participants will receive balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | Biological: Balugrastim<br>* Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.<br>* Other names: Neugranin;Drug: Chemotherapy Regimen<br>* 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.<br>|
| Experimental: Pilot Phase: Balugrastim Medium Dose<br>Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | Biological: Balugrastim<br>* Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.<br>* Other names: Neugranin;Drug: Chemotherapy Regimen<br>* 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.<br>|
| Experimental: Pilot Phase: Balugrastim High Dose<br>Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | Biological: Balugrastim<br>* Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.<br>* Other names: Neugranin;Drug: Chemotherapy Regimen<br>* 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.<br>|
| Active Comparator: Pilot Phase: Pegfilgrastim<br>Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | Drug: Pegfilgrastim<br>* Pegfilgrastim will be administered per dose and schedule specified in the arm description.<br>Drug: Chemotherapy Regimen<br>* 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.<br>|
| Experimental: Main Phase: Balugrastim Medium Dose<br>Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | Biological: Balugrastim<br>* Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.<br>* Other names: Neugranin;Drug: Chemotherapy Regimen<br>* 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.<br>|
| Experimental: Main Phase: Balugrastim High Dose<br>Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | Biological: Balugrastim<br>* Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.<br>* Other names: Neugranin;Drug: Chemotherapy Regimen<br>* 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.<br>|
| Active Comparator: Main Phase: Pegfilgrastim<br>Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | Drug: Pegfilgrastim<br>* Pegfilgrastim will be administered per dose and schedule specified in the arm description.<br>Drug: Chemotherapy Regimen<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer Supportive Care Neutropenia