Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

NCT01126190 | Completed Phase 3 Results DMC

• 1 other identifier: NEUGR-003
• Study Type: interventional
• Target: 381
• Locations: 5 countries
• Sites: 59

Brief Summary

Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.

Conditions

Chemotherapy-induced Neutropenia

Outcome Measures

Primary Outcomes (2)

• Double-Blind Phase: 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)

• Open-Label Phase: Duration of Severe Neutropenia in Cycle 1

  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.

  Cycle 1 (cycle length = 21 days)

Secondary Outcomes (2)

• Double-Blind Phase: Number of Participants With Febrile Neutropenia

  Cycles 1-4 (each cycle = 21 days)

• Open-Label Phase: Number of Participants With Febrile Neutropenia

  Cycles 1-4 (each cycle = 21 days)

Study Arms (3)

Double-Blind Phase: Pegfilgrastim

ACTIVE COMPARATOR

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.

Biological: Pegfilgrastim; Drug: Chemotherapy

Double-Blind Phase: Neugranin 40 mg

EXPERIMENTAL

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.

Biological: Neugranin; Drug: Chemotherapy

Open-Label Phase: Neugranin 40 mg

EXPERIMENTAL

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.

Biological: Neugranin; Drug: Chemotherapy

Interventions

Neugranin BIOLOGICAL

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

Also known as: Balugrastim

Double-Blind Phase: Neugranin 40 mg; Open-Label Phase: Neugranin 40 mg

Pegfilgrastim BIOLOGICAL

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

Also known as: Neulasta

Double-Blind Phase: Pegfilgrastim

Chemotherapy DRUG

The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination

Also known as: Doxorubicin/Docetaxel

Double-Blind Phase: Neugranin 40 mg; Double-Blind Phase: Pegfilgrastim; Open-Label Phase: Neugranin 40 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (59)

Teva Investigational Site 3502

Gabrovo, 5300, Bulgaria

Location

Teva Investigational Site 3511

Plovdiv, 4004, Bulgaria

Location

Teva Investigational Site 3504

Rousse, 7002, Bulgaria

Location

Teva Investigational Site 3501

Shumen, 9700, Bulgaria

Location

Teva Investigational Site 3506

Sofia District, 1233, Bulgaria

Location

Teva Investigational Site 3503

Stara Zagora, 6003, Bulgaria

Location

Teva Investigational Site 3505

Varna, 9010, Bulgaria

Location

Teva Investigational Site 3507

Veliko Tarnovo, 5000, Bulgaria

Location

Teva Investigational Site 4001

Baia Mare, Maramures County, 430031, Romania

Location

Teva Investigational Site 4009

Brasov, 500366, Romania

Location

Teva Investigational Site 4004

Bucharest, 020962, Romania

Location

Teva Investigational Site 4002

Cluj-Napoca, 400015, Romania

Location

Teva Investigational Site 4011

Cluj-Napoca, 999999, Romania

Location

Teva Investigational Site 4005

Craiova, Dolj County, 200535, Romania

Location

Teva Investigational Site 4010

Lasi County, 700106, Romania

Location

Teva Investigational Site 4007

Timișoara, 300239, Romania

Location

Teva Investigational Site 0714

Arkhangelsk, 163045, Russia

Location

Teva Investigational Site 0707

Chelyabinsk, 454087, Russia

Location

Teva Investigational Site 0708

Ivanovo, 153013, Russia

Location

Teva Investigational Site 0721

Kazan', 420029, Russia

Location

Teva Investigational Site 0709

Krasnodar, 350040, Russia

Location

Teva Investigational Site 0711

Kursk, 305035, Russia

Location

Teva Investigational Site 0713

Leningrad Region, 188663, Russia

Location

Teva Investigational Site 0710

Moscow, 121359, Russia

Location

Teva Investigational Site 0703

Moscow, 129128, Russia

Location

Teva Investigational Site 0716

Nizhny Novgorod, 603081, Russia

Location

Teva Investigational Site 0720

Oryol, 302020, Russia

Location

Teva Investigational Site 0724

Pyatigorsk, 357502, Russia

Location

Teva Investigational Site 0725

Rostov-on-Don, 344037, Russia

Location

Teva Investigational Site 0704

Saint Petersburg, 194017, Russia

Location

Teva Investigational Site 0722

Saint Petersburg, 195067, Russia

Location

Teva Investigational Site 0706

Saint Petersburg, 197758, Russia

Location

Teva Investigational Site 0715

Saint Petersburg, 198255, Russia

Location

Teva Investigational Site 0712

Samara, 443031, Russia

Location

Teva Investigational Site 0723

Sochi, 354057, Russia

Location

Teva Investigational Site 0717

Tambov, 392013, Russia

Location

Teva Investigational Site 0719

Ufa, 450007, Russia

Location

Teva Investigational Site 0705

Yaroslavl, 150040, Russia

Location

Teva Investigational Site 0702

Yekaterinburg, 620036, Russia

Location

Teva Investigational Site 8102

Belgrade, 11000, Serbia

Location

Teva Investigational Site 8103

Belgrade, 11000, Serbia

Location

Teva Investigational Site 8104

Kragujevac, 34000, Serbia

Location

Teva Investigational Site 8105

Niš, 18 000, Serbia

Location

Teva Investigational Site 3807

Chernihiv, 14029, Ukraine

Location

Teva Investigational Site 3805

Chernivtsi, 58013, Ukraine

Location

Teva Investigational Site 3802

Dnipropetrovsk, 49102, Ukraine

Location

Teva Investigational Site 3811

Donetsk, 83092, Ukraine

Location

Teva Investigational Site 3806

Ivano-Frankivsk, 76018, Ukraine

Location

Teva Investigational Site 3814

Kharkiv, 61024, Ukraine

Location

Teva Investigational Site 3804

Kharkiv, 61070, Ukraine

Location

Teva Investigational Site 3816

Kharkiv, 61070, Ukraine

Location

Teva Investigational Site 3803

Khmelnytskyi, 29009, Ukraine

Location

Teva Investigational Site 3808

Kyiv, 03115, Ukraine

Location

Teva Investigational Site 3817

Kyiv, 03115, Ukraine

Location

Teva Investigational Site 3812

Lviv, 79031, Ukraine

Location

Teva Investigational Site 3809

Mariupol, Donetsk Region, 87500, Ukraine

Location

Teva Investigational Site 3801

Odesa, 65025, Ukraine

Location

Teva Investigational Site 3815

Sumy, 40005, Ukraine

Location

Teva Investigational Site 3810

Uzhhorod, 88014, Ukraine

Location

Related Publications (1)

• Volovat C, Gladkov OA, Bondarenko IM, Barash S, Buchner A, Bias P, Adar L, Avisar N. Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer receiving chemotherapy. Clin Breast Cancer. 2014 Apr;14(2):101-8. doi: 10.1016/j.clbc.2013.10.001. Epub 2013 Oct 25.

  PMID: 24485296 DERIVED

MeSH Terms

Interventions

balugrastim; pegfilgrastim; Drug Therapy; Doxorubicin; Docetaxel

Intervention Hierarchy (Ancestors)

Therapeutics; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 19, 2010
• Study Start: June 30, 2010
• Primary Completion: February 29, 2012
• Study Completion: February 29, 2012
• Last Updated: March 28, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-02

Locations

UA (16); SE (4); RO (8); BU (8); RU (23)