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 ID: NCT00338286

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2098 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-02
• Study Completion Date: 2017-01-31

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.

Detailed Description

Anemia is a common complication of the treatment of metastatic breast cancer and is related to the effects of chemotherapy and to chronic disease itself. This is a randomized, open-label, multicenter, international study to further examine the safety of the study drug used with standard supportive care (i.e., packed RBC transfusions) compared to standard supportive care alone, when used to treat anemia associated with chemotherapy. This study will be done in subjects with metastatic breast cancer who are being or will be treated with first-line chemotherapy with standard dose schedules of taxane monotherapy, or a taxane plus trastuzumab, or an anthracycline plus either a taxane or cyclophosphamide. The study hypothesis is that epoetin alfa, when used as supportive anemia care, does not increase the risk of tumor progression or death. The study treatment will be compared to the control treatment by comparing progression-free survival, i.e., the number of months from the date a patient is randomized into the trial to the date of the first documented disease progression or death. In addition to their chemotherapy, half of the subjects will be assigned to receive study drug (epoetin alfa) and half of the subjects will be assigned to standard supportive care for anemia. Subjects treated with the study drug will receive standard supportive care (packed RBC transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first.The hypothesis is to test that epoetin alfa, when used as supportive anemia care, is non-inferior to control (standard supportive care alone), as measured by progression free survival (PFS). Patients treated with the study drug will receive standard supportive care (packed red blood cells (RBC) transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first. Dose adjustments (dose escalation, dose reduction, dose interruption, and dose resumption) of epoetin alfa will be based on hemoglobin (Hb) and confirm to prescribing information.

Conditions

Breast Cancer; Neoplasm Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

001

epoetin alfa + packed RBC transfusion 40 000 IU SC once a week.

Group Type: EXPERIMENTAL

epoetin alfa + packed RBC transfusion

Intervention Type: DRUG

40,000 IU SC once a week.

002

Standard supportive care (packed RBC transfusion) Per doctor prescription

Group Type: OTHER

Standard supportive care (packed RBC transfusion)

Intervention Type: OTHER

Per doctor prescription

Interventions

Standard supportive care (packed RBC transfusion)

Per doctor prescription

Intervention Type: OTHER

epoetin alfa + packed RBC transfusion

40,000 IU SC once a week.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC C. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Anaheim, California, United States

Gainesville, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

Rockledge, Florida, United States

Hazard, Kentucky, United States

Alexandria, Louisiana, United States

Marrero, Louisiana, United States

Jackson, Mississippi, United States

Lake Success, New York, United States

Staten Island, New York, United States

Philadelphia, Pennsylvania, United States

Corpus Christi, Texas, United States

Houston, Texas, United States

Buenos Aires, , Argentina

Capital Federal, , Argentina

Ciudad Autonoma de Buenos Airess, , Argentina

Córdoba, , Argentina

La Plata, , Argentina

Mendoza, , Argentina

Quilmes, , Argentina

Rosario, , Argentina

Santa Fe, , Argentina

Barretos, , Brazil

Curitiba, , Brazil

Goiânia/Go, , Brazil

Ijuí, , Brazil

Jaú, , Brazil

Piracicaba, , Brazil

Porto Alegre, , Brazil

Ribeirão Preto/Sp, , Brazil

Santo André, , Brazil

São José do Rio Preto, , Brazil

São Paulo, , Brazil

São Paulol, , Brazil

Plovdiv, , Bulgaria

Rousse, , Bulgaria

Sofia, , Bulgaria

Stara Zagora, , Bulgaria

Varna, , Bulgaria

Arica, , Chile

Santiago, , Chile

Temuco, , Chile

Valdivia, , Chile

Valparaíso, , Chile

Bogotá, , Colombia

Floridablanca-Santander, , Colombia

Montería, , Colombia

Cuenca, , Ecuador

Guayaquil, , Ecuador

Portoviejo, , Ecuador

Quito, , Ecuador

Batumi, , Georgia

Tbilisi, , Georgia

New Territories, , Hong Kong

Ahmedabad, , India

Andra Pradesh, , India

Bangalore, , India

Bengaluru, , India

Bhopal, , India

Delhi, , India

Hyderabad, , India

Jaipur, , India

Kārnād, , India

Kerala, , India

Kochi, , India

Kolkata, , India

Mangalore, , India

Mumbai, , India

Nashik, , India

New Delhi, , India

Pune, , India

Tamil Nadu Na, , India

Tamil Nadu, , India

Thiruvananthapuram, , India

Uttar Pradesh, , India

Vellore, , India

Bandung, , Indonesia

Jakarta, , Indonesia

Semarang, , Indonesia

Yogyakarta, , Indonesia

George Town, , Malaysia

Kampung Baharu Nilai, , Malaysia

Kelantan, , Malaysia

Kuala Lumpur, , Malaysia

Tanjung Bungah, , Malaysia

Chihuahua City, , Mexico

Guerrero, , Mexico

León, , Mexico

Mérida, , Mexico

Morelia, , Mexico

Puebla City, , Mexico

San Luis Potosí City, , Mexico

Sinaloa, , Mexico

Zapopan, , Mexico

Bitola, , North Macedonia

Skopje, , North Macedonia

Cebu, , Philippines

Davao City, , Philippines

Iloilo City, , Philippines

Manila, , Philippines

Quezon City, , Philippines

Bialystok, , Poland

Gdansk, , Poland

Gliwice, , Poland

Katowice, , Poland

Krakow, , Poland

Lodz, , Poland

Olsztyn, , Poland

Poznan, , Poland

Wroclaw, , Poland

Brasov, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Iași, , Romania

Onești, , Romania

Sibiu, , Romania

Suceava, , Romania

Timișoara, , Romania

Arkhangelsk, , Russia

Balashikha, , Russia

Belgorod, , Russia

Chelyabinsk, , Russia

Engels Saratov Region, , Russia

Ivanovo, , Russia

Kazan', , Russia

Krasnodar, , Russia

Leningrad Region, , Russia

Lipetsk, , Russia

Magnitogorsk, , Russia

Moscow, , Russia

Novosibirsk, , Russia

Obninsk, , Russia

Orenburg, , Russia

Perm, , Russia

Pyatigorsk, , Russia

Ryazan, , Russia

Saint Petersburg, , Russia

Smolensk, , Russia

Tyumen, , Russia

Ufa, , Russia

Voronezh, , Russia

Yekaterinburg, , Russia

Bloemfontein, , South Africa

Cape Town, , South Africa

Durban, , South Africa

Johannesburg, , South Africa

Klerksdorp, , South Africa

Port Elizabeth, , South Africa

Pretoria, , South Africa

Changhua, , Taiwan

Chiayi City, , Taiwan

Hualien City, , Taiwan

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Cherkassy, , Ukraine

Chernihiv, , Ukraine

Chernivtsi, , Ukraine

Dnipro, , Ukraine

Donetsk, , Ukraine

Ivano-Francovsk, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Lviv, , Ukraine

Odesa, , Ukraine

Poltava, , Ukraine

Sumy, , Ukraine

Uzhhorod, , Ukraine

Vinnitsa, , Ukraine

Vinnytsia, , Ukraine

Zaporizhzhya, , Ukraine

Countries

United States; Argentina; Brazil; Bulgaria; Chile; Colombia; Ecuador; Georgia; Hong Kong; India; Indonesia; Malaysia; Mexico; North Macedonia; Philippines; Poland; Romania; Russia; South Africa; Taiwan; Ukraine

References

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.

Reference Type: DERIVED

PMID: 26858335 (View on PubMed)

Other Identifiers

EPOANE3010

Identifier Type: OTHER

Identifier Source: secondary_id

CR005143

Identifier Type: OTHER

Identifier Source: secondary_id

2005-001817-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR005143

Identifier Type: -

Identifier Source: org_study_id