| CTRI Number |
CTRI/2023/07/055665 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Retrospective Study to Understand the Clinical Characteristics and
the Treatment for Breast Cancer
Patients |
|
Scientific Title of Study
|
A Retrospective Study to Understand the Clinical Characteristics and
the Treatment Patterns For HR positive, HER2 negative High-Risk Early Breast Cancer
Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Ashish Singh |
| Designation |
Assistant professor |
| Affiliation |
Christian Medical College |
| Address |
Christian Medical College, IDA Scudder Rd, Vellore, Tamil Nadu
Vellore
TAMIL NADU
632004
India |
| Phone |
6383442826 |
| Fax |
6383442826 |
| Email |
todrashish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Tarun Pandotra |
| Designation |
CEO |
| Affiliation |
Fervor Health Solutions Private Limited |
| Address |
H-1/603, DDA Multi-story, Dwarka, New-Delhi-110078, India
New Delhi
DELHI
110078
India
West
DELHI
110078
India |
| Phone |
8860009879 |
| Fax |
|
| Email |
tarun@fervorhs.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sharad Jain |
| Designation |
COO |
| Affiliation |
Fervor Health Solutions Private Limited |
| Address |
H-1/603, DDA Multi-story, Dwarka, New-Delhi-110078, India
Bangalore
KARNATAKA
560092
India
West
DELHI
560092
India |
| Phone |
8527110300 |
| Fax |
|
| Email |
sharad@fervorhs.com |
|
|
Source of Monetary or Material Support
|
| Eli Lilly and Company
Eli Lilly U.A.E. (Suisse) SA (United Arab Emirates Division) |
|
|
Primary Sponsor
|
| Name |
Clinart MENA |
| Address |
101. Building # 26. Dubai Healthcare City, Dubai 86830, UAE |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Fervor Health solutions |
H-1/603, DDA Multi-story, Dwarka, New Delhi, 110078 |
|
|
Countries of Recruitment
|
India
Saudi Arabia
Turkey
United Arab Emirates |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Senthil |
Basavatarakam Indo American Cancer Hospital & Research Institute |
Department of Oncology, Road No. 10, IAS Officers Quaters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA |
9849213102
9849213102
senthiljrajappa@gmail.com |
| Dr Ashish Singh |
Christian Medical College |
Department of oncology,
IDA Scudder Rd, Vellore, Tamil Nadu 632004
Vellore
TAMIL NADU |
6383442826
6383442826
todrashish@gmail.com |
| Dr Amrith |
Rajiv Gandhi Cancer Institute & Research Centre |
Department of oncology, Sir Chotu Ram Marg, Sector – 5, Rohini Institutional Area, Rohini, New Delhi, Delhi – 110085
West
DELHI |
9711080001
9711080001
amrithpatel@gmail.com |
| Dr Rosina Ahmed |
Tata Medical Center |
Department of oncology, 14 MAR (E-W), New Town, Rajarhat, Kolkata 700 160, West Bengal
Kolkata
WEST BENGAL |
9830108211
9830108211
rosina.ahmed@tmckolkata.com |
| Dr Akhil Kapoor |
Tata Memorial Hospital |
Department of oncology,Old Loco Colony, Shivpurwa, Varanasi, Uttar Pradesh 221010
Varanasi
UTTAR PRADESH |
7597364554
7597364554
kapoorakhil1987@gmail.com |
| Dr Sushmita Rath |
Tata Memorial Hospital |
Department of oncology, Dr. E Borges Road 1: Parel, Mumbai: Maharashtra: 400012
Mumbai
MAHARASHTRA |
9869154396
9869154396
sushmitarath73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| IEC, MPMMCC and HBCH Varanasi |
Submittted/Under Review |
| Institution Review Board, Tata Medical Center |
Submittted/Under Review |
| Institutional Ethics Committee,Basavatarakam Indo American Cancer Hospital |
Submittted/Under Review |
| Institutional Review Board (IRB) Rajiv Gandhi Cancer Institute and Research centre |
Approved |
| OFFICE RESEARCH INSTITUTIONAL REVIEW BOARD , CHRISTIAN MEDICAL COLLEGE |
Approved |
| TMH, Institutional Ethics Committee-I |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Adult women ≥18 years of age (or per local regulations).
2. The participant has confirmed HR+, HER2-, early-stage resected invasive breast cancer
without evidence of distant metastases.
3. The participant must have undergone definitive surgery of the primary breast tumor.
4. The participant must have tumor tissue from the breast (preferred) or lymph node. |
|
| ExclusionCriteria |
| Details |
1. Distant metastasis.
No other explicit exclusion criteria are defined to allow for documentation of routine clinical
practice as much as possible.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To describe the proportion of patients with a high risk of relapse, as defined by MonarchE
inclusion criteria, out of the total number of the recruited cases of HR+, HER2- early
breast cancer patients (EBC) |
At Baseline, one-time assessment only. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To describe the treatment patterns & clinical characteristics in HR positive, HER2 negative early breast
cancer patients (EBC). |
At Baseline one time assessment only. |
|
|
Target Sample Size
|
Total Sample Size="550"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/03/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current observational study aims to obtain real-world data about the proportion of patients with a high
risk of relapse, as defined by MonarchE inclusion criteria (1), out of the total number of HR+/ HER2- early
breast cancer cases, in four countries: KSA, UAE, Turkey, and India. The study also aims to obtain real world data about the treatment patterns and clinical characteristics in HR+, HER2- early breast cancer
patients. The primary study objective is to describe the proportion of patients with high risk of relapse, as defined by
MonarchE inclusion criteria*, out of the total number of the recruited cases.
The study’s secondary objective is to describe the treatment patterns and clinical characteristics in HR+,
HER2- early breast cancer patients (EBC) HR+/ HER2- early breast cancer patients with a high risk of relapse defined as patients with four or more
positive pathologic axillary lymph nodes or one to three positive axillary lymph nodes and at least one of
the following: tumour size ≥ 5 cm, histologic grade 3, or Ki-67 ≥ 20%.
All study data will be collected retrospectively from the medical records and will cover the period of 2 years
before the data collection date, from the date of early breast cancer patients (EBC) patients’ diagnosis until
patients’ inclusion dates. Since a predetermined number of cases are sought from each country, then quota
sampling will be used. Within each country/site, convenience sampling will be used to collect data from
available records. |