CTRI/2018/03/012349 [Registered on: 06/03/2018] Trial Registered Prospectively
Last Modified On:
23/11/2023
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Other
Public Title of Study
Post Marketing Study of Eribulin Mesylate in Patients with Breast Cancer
Scientific Title of Study
Post Marketing Trial (Phase IV) on the Safety, Tolerability And Efficacy of Eribulin Mesylate in Treating Patients with Locally Advanced or Metastatic Breast Cancer
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
E7389-M065-401
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Department of Oncology, Ajanta Research Centre, Ajanta Hospital & iVF Centre,765, ABC Complex,Kanpur Road,Alambagh,Lucknow 226005 Lucknow UTTAR PRADESH
09415760807 0522-4101017 vivek9537@gmail.com
Dr Dilipkumar Parida
All India Institute of medical Sciences
Department of Radiotherapy, AIIMS Road, Patrapada, Bhubaneswar, Orissa 751019 Khordha ORISSA
919438884060
drdkparida@gmail.com
Dr Amit Dhiman
Deep Hospital
481,Department of Medical and Hemato oncology Services, Model Town, Ludhiana-141002, Punjab Ludhiana PUNJAB
Khasra No 50,51,Mauza Wanjri,Bandenawaj Nagar,Near Automotive Square,Kalamana Ring Road,Nagpur 440026 Nagpur MAHARASHTRA
09833621049 - vaibhav.choudhary@hcgoncology.com
Dr Chirag Desai
Hemato-Oncology Clinic Vedanta Institute of Medical Sciences
Department of Medical Oncology,1st Floor, Stadium Commerce College Road, Navrangpura, Ahmedabad - 380 009 Ahmadabad GUJARAT
07940042223
chiragdesai.oncology@gmail.com
Dr Aloke Ghosh
IPGME&R,SSKM Hospital
Department of Radiation Oncology, 244,AJC Bose Road, kolkata-700020 Kolkata WEST BENGAL
09477095836 - alokeghoshdastidar@yahoo.com
Dr Pramod kumar Singh
J.K.Cancer Institute
Department of Radiotherapy, Rawatpur Main Rd, Gutaiya, Rawat Pur, Kanpur-208019 Kanpur Nagar UTTAR PRADESH
09838200265 - drpramodsingh16@gmail.com
Dr Shiv Rajan
King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University)
Department of Surgical Oncology, Chowk, Lucknow - 226003, Uttar Pradesh Lucknow UTTAR PRADESH
919455583068
shivrajan.194@gmail.com
Dr Wategaonkar Ravikumar Narayan
Lokmanya Holistic Cancer Care and Research Center of (LMRC)
Department of Medical Oncology,314/B, Telco Road, Chinchwad, Pune-411033 Pune MAHARASHTRA
919586587445
rnwategaonkar@gmail.com
Dr A Rajeswar
MNJ Institute of Oncology and Regional Cancer Center
Department of Surgical Oncology, Red Hills, Hyderabad- 500004, Telangana Hyderabad ANDHRA PRADESH
919949148484
Mnjiorcchyd3@gmail.com
Dr Prakash S S
Mysore Medical College and Research Institute
Department of General Surgery, Irwin Road, Mysore-570001 Mysore KARNATAKA
919901000559
prakashyesyes@yahoo.com
Dr Chinmay Kumar Basu
Netaji Subhash chandra Bose Cancer Institute
Department of Medical Oncology,16A, Park Lane, Behind Park Street Police Station, Kolkata, West Bengal 700016 Kolkata WEST BENGAL
919830114880
ckbose@hotmail.com
Dr Anjan Bera
Nilratan Sircar Medical College & Hospital
Nilratan Sircar Medical College & Hospital, Department of Radiotherapy, 138, Acharya Jagadish Chandra Bose Road,Sealdah,Kolkata - 700014 Kolkata WEST BENGAL
08336855482 - anjanbera78@gmail.com
Dr Sandeep Kumar Jasuja
R.K. Birla Cancer Center, SMS Hospital
Department of Medical Oncology & BMT, JLN Marg, Jaipur-302004 Jaipur RAJASTHAN
919660121475
sandeepjasuja@gmail.com
Dr Shyam Aggarwal
Sir Ganga Ram Hospital
Department of Medical Oncology,First Floor, Near Labor room,Sir Gangaram Hospital Marg, Rajinder Nagar, New Delhi-110060 New Delhi DELHI
9811075870
drshyam_aggarwal@yahoo.com
Dr K C Lakshmaiah
Srinivasam Cancer Care Multispecialty Hospitals India Pvt Ltd ,
# 36, 1st A Main, 5th Cross (Nethravathi Street), Maruthi Nagar, Nagarbhavi Main Road, Bangalore - 560072
Bangalore KARNATAKA
919448055949
kcluck@gmail.com
Dr Sudeep Gupta
Tata Memorial Hospital
Room No: 1109, 11th Floor, Department of Medical Oncology, Homi Bhabha Block, Dr. E. Borges Marg, Parel (East), Mumbai- 400012 Mumbai MAHARASHTRA
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, Patients with locally advanced or metastatic breast cancer, who have progressed after at least one regimens of chemotherapy which has included anthracycline and taxane therapy,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Eribulin 1.23 mg (equivalent to Eribulin mesylate 1.4mg)/m2 IV infusion
Eribulin 1.23 mg (equivalent to Eribulin mesylate 1.4mg)/m2 IV infusion given over 2 – 5 minutes on days 1 and 8 of 21 day cycle as monotherapy for 6 Cycles (6 Months)
Comparator Agent
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Females of 18 years of age or older.
2.Patients willing to give informed written consent.
3.Patients with locally advanced or metastatic breast cancer.
4.Patients must have progressed after at least after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an Anthracycline and a Taxane unless patients who are not suitable for these treatments.
5.Patients must have documented disease progression within or on 6 months from their last anti-cancer therapy.
6.ECOG performance status ≤2
7.Patients must have normal organ and marrow function as defined below:Absolute neutrophil count >1,500/mcl
Hemoglobin >10.0 g/dL
Platelets >100,000/mcL
Serum total bilirubin <1.5 X upper limit of normal (ULN)
Serum AST (SGOT) and ALT (SGPT) <3 X ULN or <5 X ULN in the presence of liver metastases
Serum Creatinine <1.5 mg/dL
8.Women in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study
ExclusionCriteria
Details
1.Pregnant and lactating females
2.Hypersensitivity to the active substance or any of the excipients
3.Patients who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start
4.Participants receiving any other investigational agents
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1.To evaluate the clinical and laboratory safety of Eribulin mesylate in treating patients with locally advanced or metastatic breast cancer, who have progressed after at least one regimens of chemotherapy which has included anthracycline and taxane therapy
six Cycles
Secondary Outcome
Outcome
TimePoints
To determine the objective response rate (ORR) with Eribulin in patients with locally advanced or metastatic breast cancer, who have progressed after at least one regimens of chemotherapy which has included anthracycline and taxane therapy
Six Cycles
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "200" Final Enrollment numbers achieved (India)="200"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Eribulin is approved in India for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.This is a phase IV prospective, single arm, post marketing trial to collect AEs and efficacy data from Eribulin treated patients in daily medical practice conditions with following approved indication in India based on the DCGI approval.