A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy

Roche

Status and phase: Completed; Phase 2

Conditions: Anemia

Treatments: Drug: Epoetin Beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT02761642

ML17503

Details and patient eligibility

About

This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult female participants with histological diagnosis of breast cancer
• Any type of chemotherapy planned for greater than or equal to (>/=) 9 weeks
• Hemoglobin level less than (<) 11 grams per deciliter (g/dL)
• Participants able to receive iron supplement, if necessary

Exclusion criteria

• Known or suspected contraindications to epoetin beta
• Pregnancy or lactation period
• Diagnosis of anemia only due to iron-deficiency
• Diagnosis of thalasemic syndromes
• Epilepsy and/or cerebral metastasis
• Blood transfusion or treatment with any erythropoietic factor within 4 weeks before study start

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Epoetin Beta

Experimental group

Description:

Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks.

Treatment:

Drug: Epoetin Beta