Anemia
Conditions
Brief summary
This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.
Interventions
DRUGEpoetin 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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response to Treatment Based on Hemoglobin Levels | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline | Baseline, Week 12 | 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. |
| 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 | 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. |
| Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment | Baseline, Week 12 | — |
| Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline | Baseline, Week 12 | 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). |
| Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL | Baseline up to Week 12 | 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. |
| Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores | Baseline, Week 12 | 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. |
| Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks | Baseline, Week 4 | — |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 197 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | Death | 3 |
| Overall Study | Did not Receive Study Treatment | 3 |
| Overall Study | Lack of Efficacy | 20 |
| Overall Study | Non-compliant | 7 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Reason Unspecified | 21 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Epoetin Beta |
|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 197 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 85 / 197 |
| serious Total, serious adverse events | 17 / 197 |
Outcome results
Primary
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.
Time frame: Week 12
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Beta | Percentage of Participants With Response to Treatment Based on Hemoglobin Levels | 46.2 percentage of participants |
Secondary
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.
Time frame: Baseline, Week 12
Population: Safety population. Here, Number Analyzed represents number of participants evaluable for the specified category.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
Secondary
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).
Time frame: Baseline, Week 12
Population: Safety population. Here, Number Analyzed represents number of participants evaluable for the specified category.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
Secondary
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.
Time frame: Baseline, Week 12
Population: Safety population. Here, Number Analyzed represents number of participants evaluable for the specified category.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
Secondary
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.
Time frame: Baseline up to Week 12
Population: Safety population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Epoetin Beta | Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL | 34.2 days |
Secondary
Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment
Time frame: Baseline, Week 12
Population: Safety population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Epoetin Beta | Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment | Baseline | 10.0 g/dL |
| Epoetin Beta | Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment | Change at Week 12 | 1.6 g/dL |
Secondary
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
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Beta | 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 |
Secondary
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Epoetin Beta | Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores | Baseline | 65.6 units on a scale |
| Epoetin Beta | Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores | Week 12 | 71.9 units on a scale |