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

NCT00837265 | Completed Phase 2 Results DMC

• 1 other identifier: NEUGR-002
• Study Type: interventional
• Target: 334
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chemotherapy-induced Neutropenia

Keywords

Breast Cancer Supportive Care Neutropenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With Febrile Neutropenia

  Cycles 1 to 4 (each cycle length = 21 days)

• Duration of Severe Neutropenia in Cycles 2, 3, and 4

  Cycles 2, 3, and 4 (each cycle length = 21 days)

• Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4

  Cycles 1, 2, 3, and 4

Study Arms (7)

Pilot Phase: Balugrastim Low Dose

EXPERIMENTAL

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; Drug: Chemotherapy Regimen

Pilot Phase: Balugrastim Medium Dose

EXPERIMENTAL

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; Drug: Chemotherapy Regimen

Pilot Phase: Balugrastim High Dose

EXPERIMENTAL

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; Drug: Chemotherapy Regimen

Pilot Phase: Pegfilgrastim

ACTIVE COMPARATOR

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; Drug: Chemotherapy Regimen

Main Phase: Balugrastim Medium Dose

EXPERIMENTAL

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; Drug: Chemotherapy Regimen

Main Phase: Balugrastim High Dose

EXPERIMENTAL

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; Drug: Chemotherapy Regimen

Main Phase: Pegfilgrastim

ACTIVE COMPARATOR

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; Drug: Chemotherapy Regimen

Interventions

Balugrastim BIOLOGICAL

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

Also known as: Neugranin

Main Phase: Balugrastim High Dose; Main Phase: Balugrastim Medium Dose; Pilot Phase: Balugrastim High Dose; Pilot Phase: Balugrastim Low Dose; Pilot Phase: Balugrastim Medium Dose

Pegfilgrastim DRUG

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

Main Phase: Pegfilgrastim; Pilot Phase: Pegfilgrastim

Chemotherapy Regimen DRUG

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.

Main Phase: Balugrastim High Dose; Main Phase: Balugrastim Medium Dose; Main Phase: Pegfilgrastim; Pilot Phase: Balugrastim High Dose; Pilot Phase: Balugrastim Low Dose; Pilot Phase: Balugrastim Medium Dose; Pilot Phase: Pegfilgrastim

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

MeSH Terms

Interventions

balugrastim; pegfilgrastim; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

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

USMedInfo@tevapharm.com

1-888-483-8279

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 5, 2009
• Study Start: August 21, 2008
• Primary Completion: June 26, 2009
• Study Completion: June 26, 2009
• Last Updated: April 3, 2024
• Results First Posted: February 3, 2023

Record last verified: 2024-04