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

Phase 2

Completed

• Conditions: Anemia
• Interventions: Drug: Epoetin Beta

• Registration Number: NCT02761642
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02-29
• Primary Completion: 2007-03-31
• Study Completion: 2007-03-31
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Results First Submitted: 2017-05-15
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-23
• Last Update Submitted: 2018-08-23
• Results First Posted: 2018-08-24
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epoetin Beta	Epoetin Beta	Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Response to Treatment Based on Hemoglobin Levels	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 Outcome Measures

Name	Time	Method
Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores	Baseline, Week 12	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.
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline	Baseline, Week 12	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).
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline	Baseline, Week 12	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.
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	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.
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	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.