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

February 15, 2018 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2098

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Capital Federal, Argentina
      • Ciudad Autonoma De Buenos Airess, Argentina
      • Cordoba, Argentina
      • La Plata, Argentina
      • Mendoza, Argentina
      • Quilmes, Argentina
      • Rosario, Argentina
      • Santa Fe, Argentina
  • Brazil
      • Barretos, Brazil
      • Curitiba, Brazil
      • Goiânia/Go, Brazil
      • Ijuí, Brazil
      • Jau, Brazil
      • Piracicaba, Brazil
      • Porto Alegre, Brazil
      • Ribeirão Preto/Sp, Brazil
      • Santo Andre, Brazil
      • Sao Paulo, Brazil
      • São José Do Rio Preto, Brazil
      • São Paulol, Brazil
  • Bulgaria
      • Plovdiv, Bulgaria
      • Rousse, Bulgaria
      • Sofia, Bulgaria
      • Stara Zagora, Bulgaria
      • Varna, Bulgaria
  • Chile
      • Arica, Chile
      • Santiago, Chile
      • Temuco, Chile
      • Valdivia, Chile
      • Valparaiso, Chile
  • Colombia
      • Bogota, Colombia
      • Floridablanca-Santander, Colombia
      • Monteria, Colombia
  • Ecuador
      • Cuenca, Ecuador
      • Guayaquil, Ecuador
      • Portoviejo, Ecuador
      • Quito, Ecuador
  • Georgia
      • Batumi, Georgia
      • Tbilisi, Georgia
      • Tblisi, Georgia
  • Hong Kong
      • New Territories, Hong Kong
  • India
      • Ahmedabad, India
      • Andra Pradesh, India
      • Bangalore, India
      • Bangalore N/A, India
      • Bhopal, India
      • Cochin, India
      • Delhi, India
      • Hyderabad, India
      • Jaipur, India
      • Karnad, India
      • Kerala, India
      • Kolkata, India
      • Mangalore, India
      • Mumbai, India
      • Nashik, India
      • New Delhi, India
      • Pune, India
      • Tamil Nadu, India
      • Tamil Nadu Na, India
      • Thiruvananthapuram, India
      • Uttar Pradesh, India
      • Vellore, India
  • Indonesia
      • Bandung, Indonesia
      • Jakarta, Indonesia
      • Semarang, Indonesia
      • Yogyakarta, Indonesia
  • Macedonia, The Former Yugoslav Republic of
      • Bitola, Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of
  • Malaysia
      • Georgetown, Malaysia
      • Kelantan, Malaysia
      • Kuala Lumpur, Malaysia
      • Nilai, Malaysia
      • Tanjung Bunga, Malaysia
  • Mexico
      • Chihuahua, Mexico
      • Guerrero, Mexico
      • Leon, Mexico
      • Merida, Mexico
      • Morelia, Mexico
      • Puebla, Mexico
      • San Luis Potosi, Mexico
      • Sinaloa, Mexico
      • Zapopan, Mexico
  • Philippines
      • Cebu, Philippines
      • Davao City, Philippines
      • Iloilo City, Philippines
      • Manila, Philippines
      • Quezon City, Philippines
  • Poland
      • Białystok, Poland
      • Gdansk, Poland
      • Gliwice, Poland
      • Katowice N/A, Poland
      • Kraków, Poland
      • Lodz, Poland
      • Olsztyn, Poland
      • Poznan, Poland
      • Wroclaw, Poland
  • Romania
      • Brasov, Romania
      • Bucuresti, Romania
      • Cluj-Napoca, Romania
      • Iasi, Romania
      • Onesti, Romania
      • Sibiu, Romania
      • Suceava, Romania
      • Timisoara, Romania
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Balashikha, Russian Federation
      • Belgorod, Russian Federation
      • Chelyabinsk, Russian Federation
      • Ekaterinburg, Russian Federation
      • Engels Saratov Region, Russian Federation
      • Ivanovo, Russian Federation
      • Kazan, Russian Federation
      • Krasnodar, Russian Federation
      • Leningrad Region, Russian Federation
      • Lipetsk, Russian Federation
      • Magnitogorsk, Russian Federation
      • Moscow, Russian Federation
      • Novosibirsk, Russian Federation
      • Obninsk, Russian Federation
      • Orenburg, Russian Federation
      • Perm, Russian Federation
      • Pyatigorsk, Russian Federation
      • Ryazan, Russian Federation
      • Smolensk, Russian Federation
      • St Petersburg, Russian Federation
      • St. Petersburg, Russian Federation
      • Tyumen, Russian Federation
      • Ufa, Russian Federation
      • Voronezh, Russian Federation
  • South Africa
      • Bloemfontein, South Africa
      • Cape Town, South Africa
      • Durban, South Africa
      • Johannesburg, South Africa
      • Klerksdorp, South Africa
      • Port Elizabeth N/A, South Africa
      • Pretoria, South Africa
  • Taiwan
      • Changhua, Taiwan
      • Chiayi, Taiwan
      • Hualien, Taiwan
      • Kaohsiung, Taiwan
      • Taichung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
      • Taipei 112, Taiwan
      • Tao-Yuan, Taiwan
  • Ukraine
      • Cherkassy, Ukraine
      • Chernihiv, Ukraine
      • Chernivtsi, Ukraine
      • Dnepropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Ivano-Francovsk, Ukraine
      • Kharkiv, Ukraine
      • Kiev, Ukraine
      • Lviv, Ukraine
      • Odessa, Ukraine
      • Poltava, Ukraine
      • Sumy, Ukraine
      • Uzhgorod, Ukraine
      • Vinnitsa, Ukraine
      • Vinnytsia, Ukraine
      • Zaporozhye, Ukraine
  • United States
    • California
      • Anaheim, California, United States
    • Florida
      • Gainesville, Florida, United States
      • Miami, Florida, United States
      • New Port Richey, Florida, United States
      • Rockledge, Florida, United States
    • Kentucky
      • Hazard, Kentucky, United States
    • Louisiana
      • Alexandria, Louisiana, United States
      • Marrero, Louisiana, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • New York
      • Lake Success, New York, United States
      • Staten Island, New York, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Corpus Christi, Texas, United States
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
epoetin alfa + packed RBC transfusion 40 000 IU SC once a week.
Drug: epoetin alfa + packed RBC transfusion
40,000 IU SC once a week.
Other: 002
Standard supportive care (packed RBC transfusion) Per doctor prescription
Other: Standard supportive care (packed RBC transfusion)
Per doctor prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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.
From randomization up to death from any cause (up to 8.4 years)
Time to Tumor Progression
Time Frame: 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).
From date of randomization to the date of the first documented PD (up to 8.4 years)
Overall Response Rate (ORR)
Time Frame: 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.
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)
Time Frame: up to 8.4 years
Suspected TVEs were identified by investigators and relevant clinical information was collected.
up to 8.4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2006

Primary Completion (Actual)

July 7, 2014

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

June 16, 2006

First Submitted That Met QC Criteria

June 16, 2006

First Posted (Estimate)

June 20, 2006

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005143 (Other Identifier: Janssen Research & Development, LLC)
  • EPOANE3010 (Other Identifier: Janssen Research & Development, LLC)
  • 2005-001817-17 (EudraCT Number: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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