Trial · NCT00338286
A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
NCT00338286, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2016-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy. Trials, record NCT00338286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00338286
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
- NCT number
- NCT00338286
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,098 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Interventions
- Standard supportive care (packed RBC transfusion), epoetin alfa + packed RBC transfusion
- First posted
- 2006-06-20
- Last updated
- 2018-03-19
- Other registries' IDs
- eudract:2005-001817-17
- Results first posted
- 2016-03-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years) | Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment. |
| Secondary | Overall Survival | From randomization up to death from any cause (up to 8.4 years) | Overall survival (OS) was defined as the interval between the date of randomization to the date of death from any cause. For participants who were lost to follow-up or withdrew before the final database lock, OS was censored at the last date the participants was known to be alive. For participants who were still alive and on study at the time of the final database lock, OS was censored at the date of final database lock. |
| Secondary | Time to Tumor Progression | From date of randomization to the date of the first documented PD (up to 8.4 years) | The Time to tumor progression (TTP) was defined as the time from the date of starting treatment until the date of first documented evidence of progression of tumor. TTP was measured from the date of randomization to the date of the first documented PD (including death due to PD without prior PD). |
| Secondary | Overall Response Rate (ORR) | every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years) | Overall response was RECIST criteria. Complete response (CR) is appearance of all target and non-target lesions. Partial response (PR):a) 30% decrease in sum of lactate dehydrogenase(LD) of target lesions from baseline OR b) complete disappearance of target lesions, with persistence of one or more non-target measurable lesion or one or more non-measurable, evaluable lesions. Progressive disease(PD):a) 20% increase in sum of LDs of target lesions, taking as reference smallest sum LD recorded since treatment started; OR b) appearance of one or more new lesions or a clear worsening of measurable non-target lesions or evaluable disease with stable measurable lesions. Stable disease (SD):a) sufficient shrinkage to qualify for PR;b) sufficient increase to qualify for PD. Non evaluable(NE) lesion: all other lesions, including small lesions (longest diameter \<20 millimeter (mm) with conventional techniques or \<10 mm with spiral CT scan) and truly non-measurable lesions. |
| Secondary | Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs) | up to 8.4 years | Suspected TVEs were identified by investigators and relevant clinical information was collected. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years) | The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group. | Months | MEDIAN |
| SECONDARY | Overall Survival | From randomization up to death from any cause (up to 8.4 years) | The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group. | Months | MEDIAN |
| SECONDARY | Time to Tumor Progression | From date of randomization to the date of the first documented PD (up to 8.4 years) | The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years) | The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs) | up to 8.4 years | The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | Standard of Care (SOC) | 7.4 | 95% Confidence Interval 7.1 to 7.6 | Months | |
| Progression Free Survival | Epoetin Alfa | 7.4 | 95% Confidence Interval 6.9 to 7.6 | Months | |
| Overall Survival | Standard of Care (SOC) | 18.0 | 95% Confidence Interval 16.6 to 19.6 | Months | |
| Overall Survival | Epoetin Alfa | 17.8 | 95% Confidence Interval 16.6 to 19.1 | Months | |
| Time to Tumor Progression | Standard of Care (SOC) | 7.5 | 95% Confidence Interval 7.4 to 8.0 | Months | |
| Time to Tumor Progression | Epoetin Alfa | 7.5 | 95% Confidence Interval 7.4 to 7.9 | Months | |
| Overall Response Rate (ORR) | Standard of Care (SOC) | Complete response (CR) | 3 | Percentage of participants | |
| Overall Response Rate (ORR) | Epoetin Alfa | Complete response (CR) | 3 | Percentage of participants | |
| Overall Response Rate (ORR) | Standard of Care (SOC) | Partial response (PR) | 48 | Percentage of participants | |
| Overall Response Rate (ORR) | Epoetin Alfa | Partial response (PR) | 47 | Percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Supportive Care (SOC) | 1,048 | |
| Overall Study | STARTED | Epoetin Alfa | 1,050 | |
| Overall Study | COMPLETED | Standard Supportive Care (SOC) | 815 | |
| Overall Study | COMPLETED | Epoetin Alfa | 837 | |
| Overall Study | NOT COMPLETED | Standard Supportive Care (SOC) | 233 | |
| Overall Study | NOT COMPLETED | Epoetin Alfa | 213 |
Source ClinicalTrials.gov
Adverse events582
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Standard Supportive Care (SOC) | 153 | 1,045 | |
| other | Anaemia | Blood and lymphatic system disorders | Epoetin Alfa | 98 | 1,051 | |
| other | Leukopenia | Blood and lymphatic system disorders | Standard Supportive Care (SOC) | 279 | 1,045 | |
| other | Leukopenia | Blood and lymphatic system disorders | Epoetin Alfa | 270 | 1,051 | |
| other | Neutropenia | Blood and lymphatic system disorders | Standard Supportive Care (SOC) | 550 | 1,045 | |
| other | Neutropenia | Blood and lymphatic system disorders | Epoetin Alfa | 530 | 1,051 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Standard Supportive Care (SOC) | 97 | 1,045 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Epoetin Alfa | 95 | 1,051 | |
| other | Constipation | Gastrointestinal disorders | Standard Supportive Care (SOC) | 40 | 1,045 | |
| other | Constipation | Gastrointestinal disorders | Epoetin Alfa | 53 | 1,051 |
1 to 10 of 582Source ClinicalTrials.gov
See all 582 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Supportive Care (SOC) | ||
| Total, all-cause mortality | Epoetin Alfa | ||
| Total, other adverse events | Standard Supportive Care (SOC) | 883 | 1,045 |
| Total, other adverse events | Epoetin Alfa | 898 | 1,051 |
| Total, serious adverse events | Standard Supportive Care (SOC) | 229 | 1,045 |
| Total, serious adverse events | Epoetin Alfa | 251 | 1,051 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26858335 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Standard Supportive Care (SOC) vs Epoetin Alfa: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00338286
GET https://conductscience.org/api/trials/v1/NCT00338286/events?page=2