A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

ClinicalTrials.gov ID

NCT00338286

Acronym / sponsor ID

CR005143

Conditions

Breast Cancer, Neoplasm Metastasis

Keywords

anemia, metastatic breast cancer, Hemoglobin, progression-free survival (PFS), erythropoiesis-stimulating agents (ESA)

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

2,098 participants (actual)

Lead sponsor

Janssen Research & Development, LLCIndustry (pharma, biotech, devices)

Study start

2 Mar 2006 (actual)

Primary completion

7 Jul 2014 (actual)

Study completion

31 Jan 2017 (actual)

First posted

20 Jun 2006 (estimated)

Results

Posted 24 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

2

Who may qualify

Ages

18 to 99 years

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Progression Free Survival

   Time frame: 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 26858335Leyland-Jones B, Bondarenko I, Nemsadze G, Smirnov V, Litvin I, Kokhreidze I, Abshilava L, Janjalia M, Li R, Lakshmaiah KC, Samkharadze B, Tarasova O, Mohapatra RK, Sparyk Y, Polenkov S, Vladimirov V, Xiu L, Zhu E, Kimelblatt B, Deprince K, Safonov I, Bowers P, Vercammen E. A Randomized, Open-Label, Multicenter, Phase III Study of Epoetin Alfa Versus Best Standard of Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy. J Clin Oncol. 2016 Apr 10;34(11):1197-207. doi: 10.1200/JCO.2015.63.5649. Epub 2016 Feb 8.

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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.

174 sites in 21 countries: see every site and its status.