Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
- Conditions
- Chemotherapy-induced Neutropenia
- Interventions
- Biological: PegfilgrastimBiological: NeugraninDrug: Chemotherapy
- Registration Number
- NCT01126190
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 381
- Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel)
- Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-Blind Phase: Pegfilgrastim Pegfilgrastim Participants will receive pegfilgrastim 6 milligrams (mg), 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). The chemotherapy regimen consists of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. Double-Blind Phase: Pegfilgrastim Chemotherapy Participants will receive pegfilgrastim 6 milligrams (mg), 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). The chemotherapy regimen consists of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. Double-Blind Phase: Neugranin 40 mg Neugranin Participants will receive neugranin 40 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). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. Double-Blind Phase: Neugranin 40 mg Chemotherapy Participants will receive neugranin 40 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). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. Open-Label Phase: Neugranin 40 mg Neugranin Participants will receive neugranin 40 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). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. Open-Label Phase: Neugranin 40 mg Chemotherapy Participants will receive neugranin 40 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). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
- Primary Outcome Measures
Name Time Method Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1 Cycle 1 (cycle length = 21 days) 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.
Open-Label Phase: Duration of Severe Neutropenia in Cycle 1 Cycle 1 (cycle length = 21 days) 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. There was no planned statistical analysis for the open-label phase arm.
- Secondary Outcome Measures
Name Time Method Double-Blind Phase: Number of Participants With Febrile Neutropenia Cycles 1-4 (each cycle = 21 days) Febrile neutropenia was defined as an imputed or observed ANC \<0.5 x 10\^9/L and body temperature \>38.5 degrees celsius (°C) occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Open-Label Phase: Number of Participants With Febrile Neutropenia Cycles 1-4 (each cycle = 21 days) Febrile neutropenia was defined as an imputed or observed ANC \<0.5 x 10\^9/L and body temperature \>38.5 °C occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Trial Locations
- Locations (59)
Teva Investigational Site 3502
🇧🇬Gabrovo, Bulgaria
Teva Investigational Site 3511
🇧🇬Plovdiv, Bulgaria
Teva Investigational Site 3504
🇧🇬Ruse, Bulgaria
Teva Investigational Site 3501
🇧🇬Shumen, Bulgaria
Teva Investigational Site 3506
🇧🇬Sofia District, Bulgaria
Teva Investigational Site 3503
🇧🇬Stara Zagora, Bulgaria
Teva Investigational Site 3505
🇧🇬Varna, Bulgaria
Teva Investigational Site 3507
🇧🇬Veliko Tarnovo, Bulgaria
Teva Investigational Site 4001
🇷🇴Baia Mare, Maramures County, Romania
Teva Investigational Site 4009
🇷🇴Brasov, Romania
Scroll for more (49 remaining)Teva Investigational Site 3502🇧🇬Gabrovo, Bulgaria