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

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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)

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

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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