| CTRI Number |
CTRI/2023/09/057359 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
02/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study to check the outcomes of Triple Negative Breast Cancer patients with the presence of Estrogen receptor Beta and TP53 mutation and the outcomes of adding the drug Tamoxifen in these patients. |
|
Scientific Title of Study
|
Estrogen Receptor-Beta & TP53 Status as prognostic markers in Triple Negative Breast Cancer and their clinical outcomes with Tamoxifen(Selective Estrogen Receptor Modulator) |
| 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 Navneet Kailash Agrawal |
| Designation |
Senior Resident in Medical Oncology |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Medical Oncology,Room number 4,A Block,Tower 3,Ground floor,Amrita Institute of Medical Sciences, AIMS Health Sciences Campus, AIMS Ponekkara, Kochi, 682041, Kerala, India
Ernakulam
KERALA
682041
India |
| Phone |
9450594972 |
| Fax |
|
| Email |
drnavneetkagrawal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Wesley M Jose |
| Designation |
Additional Professor of Medical Oncology |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Medical Oncology,Room number 4,A Block,Tower 3,Ground floor,Amrita Institute of Medical Sciences, AIMS Health Sciences Campus, AIMS Ponekkara, Kochi, 682041, Kerala, India
Ernakulam
KERALA
682041
India |
| Phone |
7025759415 |
| Fax |
|
| Email |
wesleymjose@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Wesley M Jose |
| Designation |
Additional Professor of Medical Oncology |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Medical Oncology,Room number 4,A Block,Tower 3,Ground floor,Amrita Institute of Medical Sciences, AIMS Health Sciences Campus, AIMS Ponekkara, Kochi, 682041, Kerala, India
Ernakulam
KERALA
682041
India |
| Phone |
7025759415 |
| Fax |
|
| Email |
wesleymjose@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences,AIMS Health Sciences Campus, AIMS Ponekkara, Kochi, 682041, Kerala, India |
|
|
Primary Sponsor
|
| Name |
NAVNEET KAILASH AGRAWAL |
| Address |
Amrita Institute of Medical Sciences, AIMS Health Sciences Campus, AIMS Ponekkara, Kochi, 682041, Kerala, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Navneet Kailash Agrawal |
Amrita Hospital |
Department of Medical Oncology,Room number 4,A Block,Tower 3,Ground Floor,Amrita Institute of Medical Sciences,AIMS Health Sciences Campus, AIMS Ponekkara, Kochi, 682041, Kerala, India.
Ernakulam
KERALA |
9450594972
drnavneetkagrawal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Amrita Institute of Medical Sciences |
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 |
| Comparator Agent |
Standard treatment |
The patients not having Estrogen Receptor beta positive and/or are TP53 wild type,will be given standard treatment for Triple Negative Breast Cancer |
| Intervention |
TAMOXIFEN 20mg |
The patients with Estrogen receptor beta positive and having TP53 mutation will be given Tab Tamoxifen 20mg OD for 5 years in addition to the standard treatment for Triple Negative Breast Cancer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1)All triple negative breast cancer patients will be included
2)All stages of breast cancer patients will be included |
|
| ExclusionCriteria |
| Details |
1)Luminal Breast Cancer patients
2)Pregnant females
3)Breastfeeding females
4)Patients receiving olaparib |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Progression free survival |
Between date of study entry and date of progression or death due to any cause for upto 24 months after therapy start |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall survival |
Between date of study entry and date of death due to any cause after therapy start |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2023 |
| 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
|
This study will evaluate the efficacy of adding Tab Tamoxifen 20mg OD in addition to standard treatment in Triple Negative Breast Cancer patients having ER Beta positive with TP53 mutation.The patients with Estrogen Beta receptor negative and/or with TP53 wild type will be given the standard treatment for Triple Negative Breast Cancer. |