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This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epoetin Beta | Experimental | Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin Beta | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arezzo | 52100 | Italy | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. | 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. | 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 |
| 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. | 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. | Baseline, Week 12 |
| Ascoli Piceno |
| 63100 |
| Italy |
| Bussolengo VR | 37012 | Italy |
| Busto Arsizio | 21052 | Italy |
| Casale Monferrato | 15033 | Italy |
| Catania | 95100 | Italy |
| Catanzaro | 88100 | Italy |
| Chieti | 66100 | Italy |
| Cuneo | 12100 | Italy |
| Fano | 61032 | Italy |
| Florence | 50139 | Italy |
| Frosinone | 03100 | Italy |
| Genova | 16132 | Italy |
| Messina | 98123 | Italy |
| Monza | 20052 | Italy |
| Naples | 80131 | Italy |
| Nocera Inferiore | 84014 | Italy |
| Pavia | 27100 | Italy |
| Pisa | 56100 | Italy |
| Pordenone | 33170 | Italy |
| Province of Macerata | 62100 | Italy |
| Roma | 00149 | Italy |
| Roma | 00168 | Italy |
| Sassari | 07100 | Italy |
| Torino | 10126 | Italy |
| Vecchiazzano | 47100 | Italy |
| Vittorio Veneto | 31029 | Italy |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population: included all enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| 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). | Safety population. Here, "Number Analyzed" represents number of participants evaluable for the specified category. | Posted | Mean | 95% Confidence Interval | g/dL | Baseline, Week 12 |
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| 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. | Safety population. Here, "Number Analyzed" represents number of participants evaluable for the specified category. | Posted | Mean | 95% Confidence Interval | g/dL | Baseline, Week 12 |
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| 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. | Safety population. Here, "Number Analyzed" represents number of participants evaluable for the specified category. | Posted | Mean | 95% Confidence Interval | g/dL | Baseline, Week 12 |
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| Secondary | Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment | Safety population | Posted | Mean | 95% Confidence Interval | g/dL | Baseline, Week 12 |
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| Secondary | Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks | Safety population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 4 |
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| 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. | Safety population | Posted | Mean | 95% Confidence Interval | days | Baseline up to Week 12 |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12 |
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Baseline up to Week 12
Safety population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 17 | 197 | 85 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Disease progression | General disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v9.0 | Non-systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Contrast media reaction | Injury, poisoning and procedural complications | MedDRA v9.0 | Non-systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v9.0 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Axillary vein thrombosis | Vascular disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v9.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA v9.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
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| Title | Denominators | Categories | ||||
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| Baseline |
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| Change at Week 12 |
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