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

Phase 3CompletedNCT00837265

Teva Branded Pharmaceutical Products R&D, Inc.334 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

334

Conditions

Chemotherapy-induced Neutropenia

Interventions

BalugrastimBIOLOGICAL

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

PegfilgrastimDRUG

Pegfilgrastim will be administered per dose and schedule specified in the arm description.

Chemotherapy RegimenDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: Cycle 1 (cycle length = 21 days)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Cycles 1, 2, 3, and 4

Data from ClinicalTrials.gov

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