Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy (NCT NCT02761642)
NCT ID: NCT02761642
Last Updated: 2018-08-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Week 12
Results posted on
2018-08-24
Participant Flow
Participant milestones
| Measure |
Epoetin Beta
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
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|---|---|
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Overall Study
STARTED
|
200
|
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Overall Study
Treated
|
197
|
|
Overall Study
COMPLETED
|
130
|
|
Overall Study
NOT COMPLETED
|
70
|
Reasons for withdrawal
| Measure |
Epoetin Beta
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
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|---|---|
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Overall Study
Did not Receive Study Treatment
|
3
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Overall Study
Adverse Event
|
13
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Non-compliant
|
7
|
|
Overall Study
Death
|
3
|
|
Overall Study
Lack of Efficacy
|
20
|
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Overall Study
Physician Decision
|
1
|
|
Overall Study
Reason Unspecified
|
21
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy
Baseline characteristics by cohort
| Measure |
Epoetin Beta
n=197 Participants
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
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|---|---|
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Age, Continuous
|
57.3 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Safety population
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.
Outcome measures
| Measure |
Epoetin Beta
n=197 Participants
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
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|---|---|
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Percentage of Participants With Response to Treatment Based on Hemoglobin Levels
|
46.2 percentage of participants
Interval 38.2 to 54.3
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SECONDARY outcome
Timeframe: Baseline, Week 12Population: Safety population. Here, "Number Analyzed" represents number of participants evaluable for the specified category.
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).
Outcome measures
| Measure |
Epoetin Beta
n=197 Participants
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
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|---|---|
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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline
Baseline; Hb <10 g/dL
|
9.4 g/dL
Interval 9.3 to 9.5
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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline
Baseline; 10≤ Hb <11 g/dL
|
10.5 g/dL
Interval 10.4 to 10.6
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|
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline
Change at Week 12; Hb <10 g/dL
|
2.1 g/dL
Interval 1.8 to 2.4
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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline
Change at Week 12; 10≤ Hb <11 g/dL
|
1.1 g/dL
Interval 0.9 to 1.3
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SECONDARY outcome
Timeframe: Baseline, Week 12Population: Safety population. Here, "Number Analyzed" represents number of participants evaluable for the specified category.
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.
Outcome measures
| Measure |
Epoetin Beta
n=197 Participants
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
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|---|---|
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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline
Baseline; Adjuvant Chemotherapy
|
10.2 g/dL
Interval 10.0 to 10.3
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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline
Baseline; Metastatic 1st or 2nd Line
|
9.8 g/dL
Interval 9.6 to 9.9
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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline
Baseline; Metastatic 3rd Line
|
10.2 g/dL
Interval 10.0 to 10.4
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|
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline
Change at Week 12; Adjuvant Chemotherapy
|
1.7 g/dL
Interval 1.4 to 2.0
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|
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline
Change at Week 12; Metastatic 1st or 2nd Line
|
1.6 g/dL
Interval 1.3 to 1.9
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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline
Change at Week 12; Metastatic 3rd Line
|
1.2 g/dL
Interval 0.8 to 1.7
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SECONDARY outcome
Timeframe: Baseline, Week 12Population: Safety population. Here, "Number Analyzed" represents number of participants evaluable for the specified category.
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.
Outcome measures
| Measure |
Epoetin Beta
n=197 Participants
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
|
|---|---|
|
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline
Baseline; <6 Months on Chemotherapy
|
10.0 g/dL
Interval 9.9 to 10.1
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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline
Baseline; ≥6 Months on Chemotherapy
|
10.0 g/dL
Interval 9.8 to 10.2
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|
Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline
Change at Week 12; <6 Months on Chemotherapy
|
1.6 g/dL
Interval 1.4 to 1.8
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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline
Change at Week 12; ≥6 Months on Chemotherapy
|
1.4 g/dL
Interval 1.0 to 1.8
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SECONDARY outcome
Timeframe: Baseline, Week 12Population: Safety population
Outcome measures
| Measure |
Epoetin Beta
n=197 Participants
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
|
|---|---|
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Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment
Baseline
|
10.0 g/dL
Interval 9.9 to 10.1
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Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment
Change at Week 12
|
1.6 g/dL
Interval 1.4 to 1.8
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Safety population
Outcome measures
| Measure |
Epoetin Beta
n=197 Participants
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
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|---|---|
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Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks
|
45.4 percentage of participants
Interval 37.85 to 53.11
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SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Safety population
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.
Outcome measures
| Measure |
Epoetin Beta
n=197 Participants
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
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|---|---|
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Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL
|
34.2 days
Interval 28.0 to 42.0
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SECONDARY outcome
Timeframe: Baseline, Week 12Population: Safety population. Here, "Number of Participants Analyzed" represents number of participants evaluable for this outcome measure and "Number Analyzed" represents number of participants evaluable at specified time points.
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.
Outcome measures
| Measure |
Epoetin Beta
n=162 Participants
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
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|---|---|
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Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores
Baseline
|
65.6 units on a scale
Interval 63.2 to 67.9
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Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores
Week 12
|
71.9 units on a scale
Interval 68.6 to 75.2
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Adverse Events
Epoetin Beta
Serious events: 17 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epoetin Beta
n=197 participants at risk
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
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|---|---|
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Blood and lymphatic system disorders
Neutropenia
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
General disorders
Disease progression
|
1.0%
2/197 • Baseline up to Week 12
Safety population
|
|
General disorders
Fatigue
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
General disorders
General physical health deterioration
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Metabolism and nutrition disorders
Cachexia
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0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Musculoskeletal and connective tissue disorders
Bone pain
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0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Nervous system disorders
Cerebrovascular accident
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Renal and urinary disorders
Renal failure
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0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
2/197 • Baseline up to Week 12
Safety population
|
|
Vascular disorders
Axillary vein thrombosis
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Vascular disorders
Hypovolaemic shock
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
|
Vascular disorders
Thrombosis
|
0.51%
1/197 • Baseline up to Week 12
Safety population
|
Other adverse events
| Measure |
Epoetin Beta
n=197 participants at risk
Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
16.2%
32/197 • Baseline up to Week 12
Safety population
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
18/197 • Baseline up to Week 12
Safety population
|
|
Gastrointestinal disorders
Nausea
|
8.6%
17/197 • Baseline up to Week 12
Safety population
|
|
General disorders
Asthenia
|
16.2%
32/197 • Baseline up to Week 12
Safety population
|
|
General disorders
Pyrexia
|
8.6%
17/197 • Baseline up to Week 12
Safety population
|
|
General disorders
Mucosal inflammation
|
7.1%
14/197 • Baseline up to Week 12
Safety population
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.6%
15/197 • Baseline up to Week 12
Safety population
|
|
Nervous system disorders
Paraesthesia
|
7.6%
15/197 • Baseline up to Week 12
Safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER