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
1 other identifier
interventional
200
1 country
27
Brief Summary
This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2004
Typical duration for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 29, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2007
CompletedFirst Submitted
Initial submission to the registry
May 3, 2016
CompletedFirst Posted
Study publicly available on registry
May 4, 2016
CompletedResults Posted
Study results publicly available
August 24, 2018
CompletedAugust 24, 2018
August 1, 2018
3.1 years
May 3, 2016
May 15, 2017
August 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Epoetin Beta
EXPERIMENTALAnemic breast cancer participants will receive epoetin beta treatment for 12 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Arezzo, 52100, Italy
Unknown Facility
Ascoli Piceno, 63100, Italy
Unknown Facility
Bussolengo VR, 37012, Italy
Unknown Facility
Busto Arsizio, 21052, Italy
Unknown Facility
Casale Monferrato, 15033, Italy
Unknown Facility
Catania, 95100, Italy
Unknown Facility
Catanzaro, 88100, Italy
Unknown Facility
Chieti, 66100, Italy
Unknown Facility
Cuneo, 12100, Italy
Unknown Facility
Fano, 61032, Italy
Unknown Facility
Florence, 50139, Italy
Unknown Facility
Frosinone, 03100, Italy
Unknown Facility
Genova, 16132, Italy
Unknown Facility
Macerata, 62100, Italy
Unknown Facility
Messina, 98123, Italy
Unknown Facility
Monza, 20052, Italy
Unknown Facility
Napoli, 80131, Italy
Unknown Facility
Nocera Inferiore, 84014, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Pisa, 56100, Italy
Unknown Facility
Pordenone, 33170, Italy
Unknown Facility
Roma, 00149, Italy
Unknown Facility
Roma, 00168, Italy
Unknown Facility
Sassari, 07100, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
Vecchiazzano, 47100, Italy
Unknown Facility
Vittorio Veneto, 31029, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2016
First Posted
May 4, 2016
Study Start
February 29, 2004
Primary Completion
March 31, 2007
Study Completion
March 31, 2007
Last Updated
August 24, 2018
Results First Posted
August 24, 2018
Record last verified: 2018-08