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Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

NCT01126190 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2023-03-28

Study results available
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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

Interventions

BIOLOGICAL

Neugranin

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

BIOLOGICAL

Pegfilgrastim

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

DRUG

Chemotherapy

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

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Bulgaria
  • Romania
  • Russia
  • Serbia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01126190 on ClinicalTrials.gov