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A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Chemotherapy Associated Neutropenia, Breast Cancer

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Trial Information

A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy


Inclusion Criteria:



1. Patients with histologically proven breast cancer, eligible for neoadjuvant or
adjuvant myelosuppressive chemotherapy

2. Women ≥ 18 years of age

3. Estimated life expectancy of more than six months

Exclusion Criteria:

1. Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in
situ carcinoma of the cervix, or other solid tumor treated curatively, and without
evidence of recurrence for at least ten years prior to study entry

2. Any serious illness or medical condition that may interfere with safety, compliance,
response to the products under investigation and their evaluation, e.g.:

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Mean duration of Grade 4 neutropenia during Cycle 1 of Chemotherapy

Outcome Description:

Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia.

Outcome Time Frame:

21 days (Cycle 1 of chemotheray treatment)

Safety Issue:

Yes

Principal Investigator

Sandoz

Investigator Role:

Study Chair

Investigator Affiliation:

Sandoz

Authority:

Russia: Ministry of Health of the Russian Federation

Study ID:

EP06-302

NCT ID:

NCT01519700

Start Date:

December 2011

Completion Date:

June 2013

Related Keywords:

  • Chemotherapy Associated Neutropenia
  • Breast Cancer
  • Filgrastim
  • G-CSF, neutropenia
  • supportive care
  • breast cancer
  • Breast Neoplasms
  • Neutropenia

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