AnemiaPhase 2NCT02761642
A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy
A Phase 2 study testing Epoetin Beta in people with Anemia, run by Hoffmann-La Roche at 27 sites in Italy.
Trial summary
This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anemia
- What is being tested?
- Epoetin Beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 27 sitesItaly
- Study dates
- 29 Feb 2004to 31 Mar 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Italy27 sites
Study site
Arezzo, 52100
Study site
Ascoli Piceno, 63100
Study site
Bussolengo VR, 37012
Study site
Busto Arsizio, 21052
Study site
Casale Monferrato, 15033
Study site
Catania, 95100
Study site
Catanzaro, 88100
Study site
Chieti, 66100
Study site
Cuneo, 12100
Study site
Fano, 61032
Study site
Florence, 50139
Study site
Frosinone, 03100
Study site
Genova, 16132
Study site
Messina, 98123
Study site
Monza, 20052
Study site
Naples, 80131
Study site
Nocera Inferiore, 84014
Study site
Pavia, 27100
Study site
Pisa, 56100
Study site
Pordenone, 33170
Study site
Province of Macerata, 62100
Study site
Roma, 00149
Study site
Roma, 00168
Study site
Sassari, 07100
Study site
Torino, 10126
Study site
Vecchiazzano, 47100
Study site
Vittorio Veneto, 31029
About this study
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
This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.
- Conditions
- Anemia
- Being tested
- Epoetin Beta
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin BetaDrug
Also called NeoRecormon
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.
| Study group | Role | What they receive |
|---|---|---|
| Epoetin Beta | Experimental | Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks. Receives: Drug: Epoetin Beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12
Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment
Measured: Baseline, Week 12
Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start29 Feb 2004
- Primary completion31 Mar 2007
- Study completion31 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761642
- Sponsor's protocol ID
- ML17503
- Status last verified
- Aug 2018
- First submitted
- 3 May 2016
- Last updated
- 24 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02761642
- Acronym / sponsor ID
- ML17503
- Conditions
- Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2004 (actual)
- Primary completion
- 31 Mar 2007 (actual)
- Study completion
- 31 Mar 2007 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Posted 24 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epoetin Beta | Experimental | Drug: Epoetin BetaAnemic breast cancer participants will receive epoetin beta treatment for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin BetaAlso: NeoRecormonAll 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. | Drug | Epoetin Beta |
Primary outcome
Percentage of Participants With Response to Treatment Based on Hemoglobin Levels
Time frame: 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.
7 secondary outcomes
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline
Time frame: Baseline, Week 12
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline
Time frame: 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
Time frame: Baseline, Week 12
Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment
Time frame: Baseline, Week 12
Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks
Time frame: Baseline, Week 4
Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL
Time frame: Baseline up to Week 12
Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study chair
Hoffmann-La Roche
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epoetin Beta in people with Anemia, run by Hoffmann-La Roche at 27 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Response to Treatment Based on Hemoglobin Levels (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.