A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
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
3 other identifiers
interventional
2,098
21 countries
174
Brief Summary
The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Mar 2006
Longer than P75 for phase_3 breast-cancer
174 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2006
CompletedFirst Submitted
Initial submission to the registry
June 16, 2006
CompletedFirst Posted
Study publicly available on registry
June 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2014
CompletedResults Posted
Study results publicly available
March 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2017
CompletedMarch 19, 2018
February 1, 2018
8.4 years
June 16, 2006
December 22, 2015
February 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
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.
From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)
Secondary Outcomes (4)
Overall Survival
From randomization up to death from any cause (up to 8.4 years)
Time to Tumor Progression
From date of randomization to the date of the first documented PD (up to 8.4 years)
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)
Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)
up to 8.4 years
Study Arms (2)
001
EXPERIMENTALepoetin alfa + packed RBC transfusion 40 000 IU SC once a week.
002
OTHERStandard supportive care (packed RBC transfusion) Per doctor prescription
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed (e.g., slide of tissue) breast cancer
- HER2/NEU positive or negative
- Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy
- Received 1st and 2nd line chemotherapy
- Hemoglobin (Hb) \<= 11g/dL at the time of randomization
- planned to receive at least 2 more cycles of chemotherapy
- Life expectancy \> 6 months
- Eastern Cooperative Oncology Group score 0 or 1
- At least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year
You may not qualify if:
- Active second cancer
- no recent history of clinically relevant thrombovascular event
- Current treatment with anticoagulants
- Brain metastasis or CNS involvement
- Anemia secondary to another cause
- Recent (within prior 1 months) use of an ESA
- Patient pregnant or breast feeding
- Progressive disease during adjuvant/neoadjuvant chemotherapy
- Rapidly progressive or life-threatening metastatic disease
- Concomitant endocrine therapy
- Patient in whom the only site of metastasis was local and was successfully treated surgically.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (174)
Unknown Facility
Anaheim, California, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Rockledge, Florida, United States
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Hazard, Kentucky, United States
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Alexandria, Louisiana, United States
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Marrero, Louisiana, United States
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Jackson, Mississippi, United States
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Lake Success, New York, United States
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Staten Island, New York, United States
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Philadelphia, Pennsylvania, United States
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Corpus Christi, Texas, United States
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Houston, Texas, United States
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Buenos Aires, Argentina
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Capital Federal, Argentina
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Ciudad Autonoma de Buenos Airess, Argentina
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Córdoba, Argentina
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La Plata, Argentina
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Mendoza, Argentina
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Quilmes, Argentina
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Rosario, Argentina
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Santa Fe, Argentina
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Barretos, Brazil
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Curitiba, Brazil
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Goiânia/Go, Brazil
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Ijuí, Brazil
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Jaú, Brazil
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Piracicaba, Brazil
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Porto Alegre, Brazil
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Ribeirão Preto/Sp, Brazil
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Santo André, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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São Paulol, Brazil
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Arica, Chile
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Santiago, Chile
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Temuco, Chile
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Valdivia, Chile
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Valparaíso, Chile
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Bogotá, Colombia
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Floridablanca-Santander, Colombia
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Montería, Colombia
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Cuenca, Ecuador
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Guayaquil, Ecuador
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Portoviejo, Ecuador
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Quito, Ecuador
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Batumi, Georgia
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Tbilisi, Georgia
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New Territories, Hong Kong
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Ahmedabad, India
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Andra Pradesh, India
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Bangalore, India
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Bengaluru, India
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Bhopal, India
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Delhi, India
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Hyderabad, India
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Jaipur, India
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Kārnād, India
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Kerala, India
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Kochi, India
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Kolkata, India
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Mangalore, India
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Mumbai, India
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Nashik, India
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New Delhi, India
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Pune, India
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Tamil Nadu Na, India
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Tamil Nadu, India
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Thiruvananthapuram, India
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Uttar Pradesh, India
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Vellore, India
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Bandung, Indonesia
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Jakarta, Indonesia
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Semarang, Indonesia
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Yogyakarta, Indonesia
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George Town, Malaysia
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Kampung Baharu Nilai, Malaysia
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Kelantan, Malaysia
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Kuala Lumpur, Malaysia
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Tanjung Bungah, Malaysia
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Chihuahua City, Mexico
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Guerrero, Mexico
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León, Mexico
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Mérida, Mexico
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Morelia, Mexico
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Puebla City, Mexico
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San Luis Potosí City, Mexico
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Sinaloa, Mexico
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Zapopan, Mexico
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Bitola, North Macedonia
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Skopje, North Macedonia
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Cebu, Philippines
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Davao City, Philippines
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Iloilo City, Philippines
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Manila, Philippines
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Quezon City, Philippines
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Bialystok, Poland
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Gdansk, Poland
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Gliwice, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Olsztyn, Poland
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Poznan, Poland
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Wroclaw, Poland
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Onești, Romania
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Sibiu, Romania
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Suceava, Romania
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Timișoara, Romania
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Arkhangelsk, Russia
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Balashikha, Russia
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Belgorod, Russia
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Chelyabinsk, Russia
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Engels Saratov Region, Russia
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Ivanovo, Russia
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Kazan', Russia
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Krasnodar, Russia
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Leningrad Region, Russia
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Lipetsk, Russia
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Magnitogorsk, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Obninsk, Russia
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Orenburg, Russia
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Perm, Russia
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Pyatigorsk, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Smolensk, Russia
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Tyumen, Russia
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Ufa, Russia
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Voronezh, Russia
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Yekaterinburg, Russia
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Bloemfontein, South Africa
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Klerksdorp, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Changhua, Taiwan
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Chiayi City, Taiwan
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Hualien City, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Cherkassy, Ukraine
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Chernihiv, Ukraine
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Chernivtsi, Ukraine
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Dnipro, Ukraine
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Donetsk, Ukraine
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Ivano-Francovsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Sumy, Ukraine
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Uzhhorod, Ukraine
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Vinnitsa, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
Related Publications (1)
Leyland-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.
PMID: 26858335DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Janssen Research and Development
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC C. Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2006
First Posted
June 20, 2006
Study Start
March 2, 2006
Primary Completion
July 7, 2014
Study Completion
January 31, 2017
Last Updated
March 19, 2018
Results First Posted
March 24, 2016
Record last verified: 2018-02