A Phase 3 Study of Epoetin Alfa plus Standard Supportive Care versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2013/09/003977
• Date of registration: 12-09-2013
• Prospective Registration: No
• Primary sponsor: Janssen Research and Development LLC
• Public title: A Phase 3 Study of Epoetin Alfa plus Standard Supportive Care versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
• Scientific 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 - Nil
• Date of first enrolment: 31-08-2006
• Target sample size: 2100
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4889
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

Bulgaria, Chile, Colombia, Ecuador, Georgia, India, Russian Federation, Taiwan, The former Yugoslav Republic of Macedonia, Ukraine, United States of America

Contacts

• Name: Dr Annappa Kamath
• Affiliation: PAREXEL International Clinical Research Private Limited

• Name: Dr Annappa Kamath
• Affiliation: PAREXEL International Clinical Research Private Limited

Key inclusion & exclusion criteria

Inclusion criteria: Subjects must satisfy the following criteria to be enrolled in the study:

. Women with histologically confirmed (at initial diagnosis) breast cancer

and clinical evidence of metastatic disease. Biopsy or cytologic confirmation of new metastatic lesion (e.g., new peripheral lung lesion) is recommended but optional depending upon center practice.



. Subjects (or their legally acceptable representatives) must have signed an

informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.



. Stage IV breast cancer and at least 1 measurable metastatic (M-1) lesion, with or without nonmeasurable lesions (e.g., bone metastases), quantified with appropriate medical imaging prior to starting the current chemotherapy regimen. Subjects whose measurable metastatic disease has become nonmeasurable by the time of randomization as a result of

response to chemotherapy will be eligible (See Attachment 1: RECIST

criteria version 1.0 with modifications).

. Age 18 years or older

. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1 (Attachment 2)

. Life expectancy of greater than 6 months, based on the clinical judgment of the investigator

. Subjects must be surgically sterile, postmenopausal for at least 1 year or

practicing an effective method of birth control (e.g., intrauterine device,

double-barrier method, male partner sterilization) for at least 30 days

before randomization, while receiving chemotherapy or epoetin alfa, and

for 12 weeks after the last dose of chemotherapy or epoetin alfa. All

subjects of childbearing potential must have a negative beta-hCG pregnancy

test within 24 hours prior to randomization.

. Receiving or will receive either first-line or second-line chemotherapy

treatment with a regimen that is considered an acceptable standard, based

on established guidelines such as NCCN21.

. Planned to receive at least 2 additional cycles of chemotherapy while on

study

. Hb less than equal to 11.0 g/dL within 24 hours prior to randomization

. Platelet count of >=100 x 10 to power 9/L

Absolute neutrophil count >1.5 x 109/L before the start of chemotherapy

or >1.0 x 109/L for subjects already on chemotherapy before

randomization

. Serum creatinine and bilirubin <1.5 times the upper limit of normal

(ULN); aspartate aminotransferase (AST), alanine aminotransferase

(ALT); alkaline phosphatase <3 times the ULN. In the presence of bone

metastases, alkaline phosphatase up to 5 times the ULN will be allowed,

provided the other liver function tests are within above limits.

. Myocardial function within normal limits for the institution, as assessed by multigated radionuclide angiography (MUGA) scan or

echocardiography, for those subjects requiring this test (see

Section 9.1.2, Screening Phase).

. HER2/NEU test result available prior to randomization.

. In countries where health authorities have approved the pharmacogenomic and proteomic testing, subjects or their legally acceptable representatives must have signed a separate informed consent for pharmacogenomic and proteomics testing indicating that they agree

or disagree to participate in these optional parts of the st
Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded

from participating in the study:

. History of:

â?? Active second cancer except for adequately treated skin cancer and in

situ cervical cancer

â?? Deep venous thrombosis (DVT) or pulmonary embolus (PE) within

12 months before study entry. Prior superficial thrombophlebitis is not

an exclusion criterion

â?? Stroke, transient ischemic attack (TIA), acute coronary syndrome

(ACS),60 or other arterial thrombosis within 6 months before study

entry. ACS includes unstable angina, Q wave myocardial infarction

(QwMI) and non-Q wave myocardial infarction (NQMI)

â?? Currently receiving therapeutic or prophylactic anticoagulants. The

only exceptions are low dose aspirin (ï?£325 mg/day) or low dose

anticoagulation (to maintain patency of intravenous [i.v.] lines)

â?? Onset of seizures within 12 weeks prior to randomization or poorly

controlled seizures

â?? Brain metastasis or CNS involvement

â?? Significant arrhythmias

New York Heart Association Stage 3 to 4 cardiac disease

(Attachment 3)

â?? Uncontrolled hypertension (systolic 180 mmHg, diastolic

100 mmHg) while receiving anti-hypertensive therapy

â?? Anemia secondary to vitamin B12 or folic acid deficiency. If mean

corpuscular volume (MCV) is 100 fl, vitamin B12 and folate

deficiency must be ruled out

â?? Anemia known to be secondary to gastrointestinal bleed, hemolysis

(acquired or hereditary, e.g., sickle cell syndrome, thalassemia

syndrome), or primary myelodysplastic syndrome

â?? Or presence of other comorbid conditions or illnesses of the

cardiovascular, respiratory, renal, or other body systems that would

preclude administration of planned chemotherapy.

. Use of ESA therapy within 30 days before randomization, lack of

response to prior therapy with ESA, or use of any investigational ESA at

any time.

. Current treatment with anticoagulants for TVE.

. Have received an experimental drug or used an experimental medical device in the setting of adjuvant/neoadjuvant therapy and within 30 days

before the planned start of treatment.

. Subject who is pregnant or breast-feeding

. Only site of metastasis was local, and was completely resected

(e.g., isolated soft tissue lesion)

. Metastasis to bone only

. Rapid progression of disease during previous chemotherapy, i.e.,

â?? For first-line treatment: progressive disease during adjuvant/neoadjuvant

chemotherapy

â?? For second-line treatment: progressive disease during the first 9 weeks

of first-line chemotherapy treatment

. Progressive disease during the current line of chemotherapy prior to randomization

. Subjects who previously received or are currently receiving dose intensification (high dose) chemotherapy regimens for bone marrow or

peripheral blood precursor cell transplantation

. Concomitant endocrine therapy (e.g., tamoxifen, aromatase inhibitors,

luteinizing hormone releasing hormone [LHRH] agonists), during

first-line or second-line chemotherapy for metastatic breast cancer.

Tamoxifen should be discontinued at least 30 days before randomization.

Aromatase inhibitors or LHRH agonists should be discontin

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Breast Cancer

Intervention(s)

Intervention1: Epoetin Alfa .: 40,000 IU on every week till subject had progression disease or stopped Chemo therapy whichever comes first
Control Intervention1: NA: NA

Primary Outcome(s)

The primary endpoints is Progression free survivalTimepoint: The time point is measured from the date of randomization to the date of the first documented disease progression or death whichever comes first. Subjects who are alive and do not have disease progression by the clinical cutoff will be censored at the dates of their last tumor evaluation

Secondary Outcome(s)

Overall SurvivalTimepoint: Overall survival is measured in months from the date of randomization to the date of death. Subjects who are living at the clinical cutoff will be censored at the date of their last observation. OS will be analyzed in a similar fashion as PFS.

Secondary ID(s)

EPO-ANE-3010;Version 23 Feb 2011; Issue date 01 March 2011

Source(s) of Monetary Support

Janssen Research and Development L.L.C.

Secondary Sponsor(s)

PAREXEL International Clinical Research Private Limited

Ethics review

Status: Approved
Approval date: 04/01/2010
Contact:

Institutional Ethics committee, Kasturba Medical College, Mangalore 575001

Status: Approved
Approval date: 01/03/2010
Contact:

Medical ethics Committee, Kidwai Institute of Medical Oncology, Dr. M.H.Marigowda Road, Bangalore 560029

Status: Approved
Approval date: 13/05/2010
Contact:

Institutional Ethics committee Denanath Mangeskar & Research Center

Status: Approved
Approval date: 01/02/2012
Contact:

EC of Institutional Review Board,Christian Medical College,Christian Medical College,BagayamVellore-632004

Status: Approved
Approval date: 20/12/2012
Contact:

Ethics Committee,B.P.Poddar Hospital and medical Research ,71/1, Humayun Kabir Sarani,Block-G, New Alipore,Kolkata-700053

Status: Approved
Approval date: 23/01/2013
Contact:

Ethics Committee-Apollo Hospitals Enterprise Limited,21, Greams Lane, Off Greams Road, Chennai- 600006, Tamil Nadu, India.

Status: Approved
Approval date: 29/01/2013
Contact:

EC of Institutional Ethics Committee,Shatabdi Super Speciality hospital ,Suyojit City Center,Maharashtra,Nasik-422005

Status: Approved
Approval date: 15/02/2013
Contact:

Ethics Committee,V S Hospital, # 13, East Spurtank Road, Chetpet, Chennai-600 031

Status: Approved
Approval date: 19/02/2013
Contact:

EC of Lakeshore Ethics Committee,Lakeshore Hospital & Research Centre,NH-47 Bypass, Maradu Nettor P.O, Kochi-682040

Status: Approved
Approval date: 22/02/2013
Contact:

EC of Institutional Ethics Committee,Bhagwan Mahaveer Cancer Hospital & Research Centre,Bhagwan Mahavir Hospital & Research Centre,Jawahar Lal Nehru, Marg,Jaipur-302017

Status: Approved
Approval date: 25/02/2013
Contact:

EC of Institutional Ethics Committee,MNJ Institute of Oncology and Regional Cancer Centre, Red Hills,Hyderabad,Andhra Pradesh-500004

Status: Approved
Approval date: 10/04/2013
Contact:

EC of Human Ethics Committee,Tata Memorial Centre,Dr. Ernest Borges Road, Parel Mumbai-400012

Status: Approved
Approval date: 13/04/2013
Contact:

Ethics Committee,Ganga Ram Hospital,Sir Ganga Ram Hospital, Rajinder Nagar,New Delhi-110060

Status: Approved
Approval date: 16/04/2013
Contact:

EC of Institutional Ethics Committee,C.S.M Medical University,Uttar Pradesh Lucknow-226003

Status: Approved
Approval date: 22/04/2013
Contact:

Ethics Committee Hehangir Clinical Development Centre Pvt Ltd, Jehangir Hospital Premises, 32 Sassoon Road, Pune-411 001

Status: Approved
Approval date: 30/04/2013
Contact:

EC of SEAROC Ethics Committee,SEAROC Cancer center,S.K. Soni Hospital,Sector 5,Vidhyadhar Nagar ,Sikar Road,Rajasthan-302013

Status: Approved
Approval date: 11/06/2013
Contact:

EC of Institutional Review Board,Rajiv Gandhi Cancer Institute & Research Centre,Sec-V, Rohini ,Delhi-110085

Status: Approved
Approval date: 14/06/2013
Contact:

Ethics Committee, Regional Cancer center, Thiruvanathpuram-695 011

Status: Approved
Approval date: 18/06/2013
Contact:

EC of Institutional Ethics Committee,Global Hospital,Lakdi-Ka-Pool,Hyderabad-500004

Status: Approved
Approval date: 16/07/2013
Contact:

Ethics Committee,Nizams Institute of Medical sciences,Nizams Institute of Medical sciences,Hyderbad,Andhra Pradesh-500082

Status: Approved
Approval date: 31/12/2013
Contact:

The Institutional Ethics Committe, office of Ethics Committee, SMS Medical College and attched Hospitals, SMS Medical College and Hospital, Jawahar Lal Nehru MArg, Jaipur-302004, Rajasthan, India

Status: Not Approved
Approval date:
Contact:

Ethics Committee, Chirayu Medical College and Hospitals, Bhainsakhedi, Near Bairagarh )Bhopal-Indore Highway, Bhapal-462 030, Madhya Pradesh, India