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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761642
• Other study ID #: ML17503
• Status: Completed
• Phase: Phase 2
• Start date: February 29, 2004
• Est. completion date: March 31, 2007

Study information

• Verified date: August 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 31, 2007
• Est. primary completion date: March 31, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Epoetin Beta
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

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