Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim (PIONEER)

Sandoz

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Chemotherapy Associated Neutropenia

Treatments: Drug: EP2006; Drug: Filgrastim

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519700

EP06-302

2010-024481-22 (EudraCT Number)

Details and patient eligibility

About

The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Enrollment: 218 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups

EP2006

Experimental group

Description:

Eligible patients will be teated with EP2006

Treatment:

Drug: EP2006

Filgrastim

Active Comparator group

Description:

Eligible patients will be teated with Filgrastim

Treatment:

Drug: Filgrastim