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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2098

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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