Multicenter Study for the Evaluation of Efficacy and Safety of NeoRecormon® Therapy Administered as 30000 IU Subcutaneously in Anemic Patients With Breast Cancer Treated With Chemotherapy

Hoffmann-La Roche0 sites200 target enrollmentFebruary 29, 2004

ConditionsAnemia

InterventionsEpoetin Beta

Overview

Phase: Phase 2
Intervention: Epoetin Beta
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Enrollment: 200
Primary Endpoint: Percentage of Participants With Response to Treatment Based on Hemoglobin Levels
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 29, 2004

End Date

March 31, 2007

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Epoetin Beta

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

Intervention: Epoetin Beta

Outcomes

Primary Outcomes

Percentage of Participants With Response to Treatment Based on Hemoglobin Levels

Time Frame: Week 12

Response was defined as increase of hemoglobin levels by at least 2 grams per deciliter (g/dL) as compared to baseline or the achievement of hemoglobin level of 12 g/dL after 12 weeks of treatment in the absence of red blood cells transfusion.

Secondary Outcomes

Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores(Baseline, Week 12)
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline(Baseline, Week 12)
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline(Baseline, Week 12)
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline(Baseline, Week 12)
Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment(Baseline, Week 12)
Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks(Baseline, Week 4)
Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL(Baseline up to Week 12)