Clinical trial NCT02761642: A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Response to Treatment Based on Hemoglobin Levels
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline
timeFrame: Baseline, Week 12
measure: Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline
timeFrame: Baseline, Week 12
measure: Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline
timeFrame: Baseline, Week 12
measure: Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment
timeFrame: Baseline, Week 12
measure: Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks
timeFrame: Baseline, Week 4
measure: Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL
timeFrame: Baseline up to Week 12
measure: Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Arezzo
country: Italy
city: Ascoli Piceno
country: Italy
city: Bussolengo VR
country: Italy
city: Busto Arsizio
country: Italy
city: Casale Monferrato
country: Italy
city: Catania
country: Italy
city: Catanzaro
country: Italy
city: Chieti
country: Italy
city: Cuneo
country: Italy
city: Fano
country: Italy
city: Firenze
country: Italy
city: Frosinone
country: Italy
city: Genova
country: Italy
city: Macerata
country: Italy
city: Messina
country: Italy
city: Monza
country: Italy
city: Napoli
country: Italy
city: Nocera Inferiore
country: Italy
city: Pavia
country: Italy
city: Pisa
country: Italy
city: Pordenone
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Sassari
country: Italy
city: Torino
country: Italy
city: Vecchiazzano
country: Italy
city: Vittorio Veneto
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: