| CTRI Number |
CTRI/2024/01/061744 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
To study the side effects and effectiveness effects of Tablet Ribociclib in hormone positive , HER2 negative breast cancer patients |
|
Scientific Title of Study
|
Real life evidence of Tab Ribociclib for Safety and Efficacy in a tertiary care centre (RERISE study). |
| 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 Sudeep Gupta |
| Designation |
Professor Medical Oncology, Director TMC |
| Affiliation |
Tata Memorial Center |
| Address |
Departmentof Medical Oncology
Room No:106 and 107,
First floor, Homi Bhabha Building
Tata Memorial Hospital
E Borges Marg.
Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| Email |
sudeepgupta04@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudeep Gupta |
| Designation |
Professor Medical Oncology, Director TMC |
| Affiliation |
Tata Memorial Center |
| Address |
Department of Medical Oncology
Room No:1109,
11 floor, Homi Bhabha Building
Tata Memorial Hospital
E Borges Marg.
Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| Email |
sudeepgupta04@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogesh Kembhavi |
| Designation |
Research Manager |
| Affiliation |
Tata Memorial Center |
| Address |
Department of Medical Onocoly
Room No:1109,
11 floor, Homi Bhabha Building
Tata Memorial Hospital
E Borges Marg.
Parel.
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09967594597 |
| Fax |
02224177201 |
| Email |
yogeshkembhavi1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre
E Borges Marg
Mumbai Parel
400012 |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable, no funding required.] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudeep Gupta |
ACTREC (Advanced Centre for Treatment, Research and Education in Cancer) |
Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210
Mumbai (Suburban)
MAHARASHTRA |
02224177201
02224177201
sudeepgupta04@yahoo.com |
| Dr Sudeep Gupta |
Tata Memorial Hospital |
Room No:1109,
11 floor, Homi Bhabha Building
Tata Memorial Hospital
E Borges Marg.
Parel.
Mumbai
Mumbai
MAHARASHTRA |
02224177201
02224177201
sudeepgupta04@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre |
Approved |
|
|
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 |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with histopathologically confirmed ER or PR positive and HER2 negative locally advanced or metastatic breast cancer
2 Patients who have been started on Ribocliclib with atleast one record of treatment with Ribociclib from the year Jun 2018 till December 2022 will be included in study. Data will be collected from the EMR
|
|
| ExclusionCriteria |
| Details |
1. Patient with HER2 positive metastatic cancer.
2. Patients with no available data on EMR.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study efficacy including Progression Free Survival and Overall Survival |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study safety and toxicity. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
26/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| 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)
|
Not Applicable |
| 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
|
In this retrospective observational study, data
will be collected from patients who have Hormone positive, HER2 negative
metastatic breast cancer and who have received Ribociclib along with endocrine
treatment from Jun 2018 till Dec 2022.
Patients with altleast
one available medical record on EMR will be included in the analysis.
Progression free survival and overall survival will be studied.
Response will be assessed post evaluation of age, menopausal
status, baseline tumor characteristics, ECOG, metastatic sites, comorbidities,
previous anticancer treatment like surgery, radiation, chemotherapy lines
received, ET lines, other ongoing treatments for comorbidities, visceral, non
visceral disease .
Data will be collected through EMR from all available records
and reports such as blood investigations, radiological reports, physician notes
and histopathological reports to assess the primary objective of the trial. Progression
free survival will be calculated from the day of starting of Ribociclib to date
of first disease progression either clinical or radiological. Overall survival
and best response will be assessed. Toxicity will be graded as per CTCAE V
4.03. Adverse events and tolerability will be assessed along with time to
recover from the toxicity. Dose reductions and interruptions will be studied. |