| CTRI Number |
CTRI/2022/01/039242 [Registered on: 07/01/2022] Trial Registered Prospectively |
| Last Modified On: |
29/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the results of hormonal treatment along with chemotherapy in previously treated hormone positive metastatic breast cancer patients. |
|
Scientific Title of Study
|
Retrospective and prospective observational study to
evaluate the outcome of patients with metastatic hormone-positive
breast cancer treated with a combination of chemotherapy and
endocrine therapy†|
| Trial Acronym |
|
|
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 |
Director ACTREC & Professor of Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no: 1109,
11th floor.
Department of Medical Oncology
Homi Bhabha Block.
Tata Memorial Hospital
E Borges Marg
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
|
| Email |
sudeepgupta04@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudeep Gupta |
| Designation |
Director ACTREC & Professor of Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Medical Oncology
Room No1109,
11th floor
Homi Bhabha Block.
Tata Memorial Hospital
E Borges Marg
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
|
| Email |
sudeepgupta04@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogesh Kembhavi |
| Designation |
Research Manager |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Medical Oncology
1109,
11th floor
Homi Bhabha Block.
Tata Memorial Hospital
E Borges Marg
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
|
| Email |
yogeshkembhavi1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudeep Gupta |
Tata Memorial Centre |
Department of Medical Oncology
Room No: 106
Homi Bhabha Block
Tata Memorial Hospital
E Borges Marg,
Parel, Mumbai
Mumbai
MAHARASHTRA |
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: C50||Malignant neoplasm of breast, |
|
|
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 |
All patients above 18 yrs who have ER and/or PR positive and HER2 negative metastatic breast cancer and who have received a combination of chemotherapy and endocrine therapy between January
2016 and December 2020. |
|
| ExclusionCriteria |
| Details |
Patients who have HER2 positive tumors. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To analyze the overall survival (OS) of included patients
2 To analyze the progression-free survival(PFS) of included
patients |
Post 6 months and 12 months of treatment completion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze the time-on-treatment of the combination of
chemo and endocrine therapy for included patients
9.3.2 To assess the toxicities from the combination of
chemotherapy and endocrine therapy, in included patients.
9.3.2 To analyze the best overall response (complete response
plus partial response, stable response or disease progression) to
combination chemotherapy and endocrine therapy |
Post 6 months and 12 months of treatment completion. |
|
|
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)
|
17/01/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To determine the outcome of metastatic breast cancer patients with ER and/or PR positive and HER2 negative tumors who have been treated with a combination of endocrine and chemotherapy |