Neoplasms

Skin and Connective Tissue Diseases

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Blood and Lymph Conditions

Breast Neoplasms

Anemia

Anti-Inflammatory Agents

Antirheumatic Agents

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Hematinics

Chrysarobin

Epoetin Alfa

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

All participants will receive epoetin beta at a dose of 30000 International Units (IU) as SC injection once every week for a total of 12 weeks. Adjustments in the dose will be implemented based on the participant's blood hemoglobin levels.

Epoetin Beta

Clinical Trials

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

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

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

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.

Participants were distributed into 2 subgroups. One subgroup contained participants who had hemoglobin (Hb) level less than (\<) 10 g/dL and other subgroup contained participants who had hemoglobin level greater than or equal to (≥) 10 g/dL but \<11 g/dL (10≤ Hb \<11 g/dL).

Participants were distributed into 3 subgroups. First subgroup contained participants who received adjuvant chemotherapy. Second subgroup contained participants who received metastatic 1st or 2nd line chemotherapy. Third subgroup contained participants who received metastatic 3rd line chemotherapy.

Participants were distributed into 2 subgroups. One subgroup contained participants who had spent \<6 months on chemotherapy and other subgroup contained participants who had spent 6 months or more on chemotherapy.

Time to increase in hemoglobin level by at least 1 g/dL was defined as the time between the start of treatment and an increase in hemoglobin level by at least 1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method.

FACT-An comprised of 2 subscales ('Fatigue' and 'Non-fatigue') of 20-items. All questions were rated on a scale from 0 to 4, where higher scores indicate improved quality of life. The 'Fatigue' subscale consists of 13 questions with score range from 0-52; 'Non-fatigue' subscale consists of 7 questions with score range from 0-28. Total FACT-An score was transformed to a 0-100 scale (instead of 0-80 scale) to get better perception of the participant's quality of life indicator.

Hoffmann-La Roche

Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.

Age, Continuous

Sex: Female, Male

Safety population: included all enrolled participants who received at least 1 dose of study drug.

Medical Communications

Percentage of Participants With Response to Treatment Based on Hemoglobin Levels

Baseline; Hb <10 g/dL

Baseline; 10≤ Hb <11 g/dL

Change at Week 12; Hb <10 g/dL

Change at Week 12; 10≤ Hb <11 g/dL

Safety population. Here, "Number Analyzed" represents number of participants evaluable for the specified category.

Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline

Baseline; Adjuvant Chemotherapy

Baseline; Metastatic 1st or 2nd Line

Baseline; Metastatic 3rd Line

Change at Week 12; Adjuvant Chemotherapy

Change at Week 12; Metastatic 1st or 2nd Line

Change at Week 12; Metastatic 3rd Line

Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline

Baseline; <6 Months on Chemotherapy

Baseline; ≥6 Months on Chemotherapy

Change at Week 12; <6 Months on Chemotherapy

Change at Week 12; ≥6 Months on Chemotherapy

Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline

Baseline

Change at Week 12

Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment

Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks

Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL

Week 12

Safety population. Here, "Number of Participants Analyzed" represents number of participants evaluable for this outcome measure and "Number Analyzed" represents number of participants evaluable at specified time points.

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

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