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CTRI Number  CTRI/2023/11/060352 [Registered on: 30/11/2023] Trial Registered Prospectively
Last Modified On: 14/11/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Unveiling ERlow Breast Cancer in India: Insights from a Multicenter Registry and Collaborative Centers on Clinicopathological Characteristics and Clinical Outcomes" 
Scientific Title of Study   Real world data on clinicopathological characteristics and clinical outcomes of ERlow breast cancer from an Indian Multicenter registry and collaborative centers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwin Oommen Philips 
Designation  Associate Professor and Head, Medical Oncology , CMC Ludhiana. 
Affiliation  Christian Medical College, Ludhiana 
Address  Ground floor , room no 19 , Medical Oncology department, CMC ,LUDHIANA
BROWN ROAD, Ludhiana
Ludhiana
PUNJAB
141008
India 
Phone  9003635373  
Fax    
Email  drashphilsmog@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ASHWIN OOMMEN PHILIPS 
Designation  ASSOCIATE PROFESSOR AND HEAD, DEPARTMENT MEDICAL ONCOLOGY CMC LUDHIANA 
Affiliation  Christian Medical College, Ludhiana 
Address  Ground floor,room no 19, Medical oncology , department CMC LUDHIANA
Brown road. Ludhiana
Ludhiana
PUNJAB
141008
India 
Phone  9003635373  
Fax    
Email  drashphilsmog@gmail.com  
 
Details of Contact Person
Public Query  
Name  ASHWIN OOMMEN PHILIPS 
Designation  Associate Professor and Head, Medical Oncology , CMC Ludhiana. 
Affiliation  Christian Medical College, Ludhiana 
Address  Ground floor, room no 19, department medical oncology, CMC Ludhiana
BROWN ROAD, Ludhiana
Ludhiana
PUNJAB
141008
India 
Phone  9003635373  
Fax    
Email  drashphilsmog@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Ludhiana 
 
Primary Sponsor  
Name  Dr ASHWIN OOMMEN PHILIPS 
Address  DEPARTMENT MEDICAL ONCOLOGY, CHRISTIAN MEDICAL COLLEGE, LUDHIANA 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr ASHWIN OOMMEN PHILIPS  CHRISTIAN MEDICAL COLLEGE, LUDHIANA  Ground floor, room no 19, department of medical oncology, CMC Ludhiana, 141008
Ludhiana
PUNJAB 		 9003635373

drashphilsmog@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IInstutional Ethics Committee Christian Medical College and Hospital Christian Medical College Hospital, Brown Road, City-Ludhiana, District- Ludhiana - Punjab - 141008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1) Patient > 18 years of age
2) Patients with a histopathological proven diagnosis of breast cancer and with an IHC report of ER low positivity ( ER 1-10% ,PR 1-10%, Her 2 negative)
 
 
ExclusionCriteria 
Details  1. < 18 years of age
2. Patients with breast cancer who are ER negative or High ER positive ( ER-0%, PR-0%, ER/PR>10%)
3. In case discrepancy between the ER status pre surgery and post surgery- the patients having high ER at any time will be excluded.
4. Her 2-3+ by IHC or FISH positive cases
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) To evaluate the the clinicopathological characteristics and clinical outcomes of ERlow breast cancer.
2) To determine the progression free survival (PFS) for patients with ERlow breast cancer.

3) To determine the overall survival (OS) for patients with ERlow breast cancer.
 		 1 YEAR, 2 YEARS, 3 YEARS , 4 YEARS , 5 YEARS
 
 
Secondary Outcome  
Outcome  TimePoints 
MODES OF TREATMENT  6months, 12 months, 18 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   11/12/2023 
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="5"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drashphilsmog@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The updated American Society of Clinical Oncology/College of American Pathologists guideline for estrogen receptor (ER) testing recommended that breast cancer with ER expression in 1–10% of tumor cells should be reported as ER-low positive (ERlow). There is however limited data that is available on the benefits of endocrine therapy on them. The aim is to understand the clinicopathological characteristics and clinical outcomes of ERlow breast cancer breast cancers based on the data from the real world especially from a developing country like India.

Aims and objectives

1)     To evaluate the the clinicopathological characteristics and clinical outcomes of ERlow breast cancer.

2)     To determine the progression free survival (PFS) for patients with  ERlow breast cancer.

3)     To determine the overall survival (OS) for patients with  ERlow breast cancer.

Methods

Retrospective multi center chart review done under the agesis of Network of oncology clinical trials in India and other collaborative centers. Data from electronic and paper bases of patients more than 18 years of age with ERlow  breast cancer from these centres will be collected from January 1st 2018 to December 31st 2022. The data would be recorded and analysed statistically. Statistical analysis will be done using SPSS software version 22.

Key words

ER, PFS, OS, Real world

 
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