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

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

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Epoetin Beta

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Arezzo, Italy, 52100
  • Ascoli Piceno, Italy, 63100
  • Bussolengo VR, Italy, 37012
  • Busto Arsizio, Italy, 21052
  • Casale Monferrato, Italy, 15033
  • Catania, Italy, 95100
  • Catanzaro, Italy, 88100
  • Chieti, Italy, 66100
  • Cuneo, Italy, 12100
  • Fano, Italy, 61032
  • Firenze, Italy, 50139
  • Frosinone, Italy, 03100
  • Genova, Italy, 16132
  • Macerata, Italy, 62100
  • Messina, Italy, 98123
  • Monza, Italy, 20052
  • Napoli, Italy, 80131
  • Nocera Inferiore, Italy, 84014
  • Pavia, Italy, 27100
  • Pisa, Italy, 56100
  • Pordenone, Italy, 33170
  • Roma, Italy, 00149
  • Roma, Italy, 00168
  • Sassari, Italy, 07100
  • Torino, Italy, 10126
  • Vecchiazzano, Italy, 47100
  • Vittorio Veneto, Italy, 31029

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epoetin Beta; Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks.	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.; Other Names: NeoRecormon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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	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
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2004
• Primary Completion (Actual): March 31, 2007
• Study Completion (Actual): March 31, 2007

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML17503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes