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 3506
🇧🇬Sofia District, Bulgaria
Teva Investigational Site 3503
🇧🇬Stara Zagora, Bulgaria
Teva Investigational Site 4011
🇷🇴Cluj-Napoca, Romania
Teva Investigational Site 0707
🇷🇺Chelyabinsk, Russian Federation
Teva Investigational Site 0711
🇷🇺Kursk, Russian Federation
Teva Investigational Site 4001
🇷🇴Baia Mare, Maramures County, Romania
Teva Investigational Site 0721
🇷🇺Kazan, Russian Federation
Teva Investigational Site 0710
🇷🇺Moscow, Russian Federation
Teva Investigational Site 4002
🇷🇴Cluj Napoca, Romania
Teva Investigational Site 0724
🇷🇺Pyatigorsk, Russian Federation
Teva Investigational Site 4005
🇷🇴Craiova, Dolj County, Romania
Teva Investigational Site 0708
🇷🇺Ivanovo, Russian Federation
Teva Investigational Site 0703
🇷🇺Moscow, Russian Federation
Teva Investigational Site 0709
🇷🇺Krasnodar, Russian Federation
Teva Investigational Site 3806
🇺🇦Ivano-Frankivsk, Ukraine
Teva Investigational Site 0719
🇷🇺Ufa, Russian Federation
Teva Investigational Site 3504
🇧🇬Ruse, Bulgaria
Teva Investigational Site 3511
🇧🇬Plovdiv, Bulgaria
Teva Investigational Site 3502
🇧🇬Gabrovo, Bulgaria
Teva Investigational Site 4009
🇷🇴Brasov, Romania
Teva Investigational Site 3501
🇧🇬Shumen, Bulgaria
Teva Investigational Site 3507
🇧🇬Veliko Tarnovo, Bulgaria
Teva Investigational Site 4010
🇷🇴Lasi County, Romania
Teva Investigational Site 4007
🇷🇴Timisoara, Romania
Teva Investigational Site 0714
🇷🇺Arkhangelsk, Russian Federation
Teva Investigational Site 0713
🇷🇺Leningrad Region, Russian Federation
Teva Investigational Site 0720
🇷🇺Orel, Russian Federation
Teva Investigational Site 0716
🇷🇺Nizhny Novgorod, Russian Federation
Teva Investigational Site 0704
🇷🇺Saint Petersburg, Russian Federation
Teva Investigational Site 0725
🇷🇺Rostov-on-Don, Russian Federation
Teva Investigational Site 0722
🇷🇺Saint Petersburg, Russian Federation
Teva Investigational Site 0715
🇷🇺Saint Petersburg, Russian Federation
Teva Investigational Site 0706
🇷🇺Saint Petersburg, Russian Federation
Teva Investigational Site 0723
🇷🇺Sochi, Russian Federation
Teva Investigational Site 0717
🇷🇺Tambov, Russian Federation
Teva Investigational Site 0705
🇷🇺Yaroslavl, Russian Federation
Teva Investigational Site 8105
🇷🇸Nis, Serbia
Teva Investigational Site 8104
🇷🇸Kragujevac, Serbia
Teva Investigational Site 3807
🇺🇦Chernihiv, Ukraine
Teva Investigational Site 3805
🇺🇦Chernivtsi, Ukraine
Teva Investigational Site 3811
🇺🇦Donetsk, Ukraine
Teva Investigational Site 3802
🇺🇦Dnipropetrovsk, Ukraine
Teva Investigational Site 3810
🇺🇦Uzhhorod, Ukraine
Teva Investigational Site 3816
🇺🇦Kharkiv, Ukraine
Teva Investigational Site 3809
🇺🇦Mariupol, Donetsk Region, Ukraine
Teva Investigational Site 3801
🇺🇦Odesa, Ukraine
Teva Investigational Site 3803
🇺🇦Khmelnytskyi, Ukraine
Teva Investigational Site 3812
🇺🇦Lviv, Ukraine
Teva Investigational Site 3808
🇺🇦Kyiv, Ukraine
Teva Investigational Site 0702
🇷🇺Ekaterinburg, Russian Federation
Teva Investigational Site 0712
🇷🇺Samara, Russian Federation
Teva Investigational Site 4004
🇷🇴Bucharest, Romania
Teva Investigational Site 3505
🇧🇬Varna, Bulgaria
Teva Investigational Site 3817
🇺🇦Kyiv, Ukraine
Teva Investigational Site 3814
🇺🇦Kharkiv, Ukraine
Teva Investigational Site 3815
🇺🇦Sumy, Ukraine
Teva Investigational Site 8102
🇷🇸Belgrade, Serbia
Teva Investigational Site 8103
🇷🇸Belgrade, Serbia
Teva Investigational Site 3804
🇺🇦Kharkiv, Ukraine