| CTRI Number |
CTRI/2023/05/052157 [Registered on: 01/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Pattern of treatment in metastatic Breast Cancer Patients |
|
Scientific Title of Study
|
Pattern of treatment and outcomes in patients with recurrent and/or metastatic triple negative breast cancer - A single institute retrospective analysis |
| Trial Acronym |
Metastatic TNBC |
|
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
Homi Bhabha Block.
E Borges Marg Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| 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 |
Room no:1109, 11th floor
Homi Bhabha Block.
E Borges Marg Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| Email |
sudeepgupta04@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogesh Kembhavi |
| Designation |
Reserch Project Manager |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no:1109,
11th floor Homi Bhabha Block. E Borges Marg Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| Email |
yogeshkembhavi1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Centre, Room no:1109,11 th floor Homi Bhabha Block. E Borges Marg Mumbai MAHARASHTRA 400012 India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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-ACTREC |
Room No. 310, 3rd floor, Paymaster Shodhika Building, ACTREC, Sector 22, Kharghar Navi Mumbai
Raigarh
MAHARASHTRA |
02224177201
02224177201
sudeepgupta04@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre ACTREC |
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 |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All individuals above 18 years of age having histopathologically proven, recurrent and/or metastatic triple negative breast cancer (mTNBC) during the period of January 2015 to June 2022.
Patients could have received any number of lines of treatment in the metastatic and/or recurrent setting.
|
|
| ExclusionCriteria |
| Details |
Patients with breast cancer without triple negative disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the treatment pattern and outcomes in patients with recurrent unresectable and/or metastatic triple negative breast cancers. |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical and radiological profile in patients with metastatic TNBC. |
24 months |
| To assess the patterns of treatment used in the management of recurrent and/or metastatic TNBC. |
24 months |
| To evaluate the OS in patients with recurrent and/or metastatic TNBC who are treated at the Tata Memorial Hospital and/or ACTREC during the study period. |
24 months |
| To evaluate the PFS in patients with recurrent and/or metastatic TNBC who receive chemotherapy and/or Immunotherapy Targeted therapy during the mentioned study period at the Tata Memorial Hospital and/or ACTREC. |
24 months |
| To assess the toxicity of treatment in included patients. |
24 months |
|
|
Target Sample Size
|
Total Sample Size="1400"
Sample Size from India="1400"
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)
|
04/05/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In India, there has been a steady increase in the incidence of breast cancer over the past decade. Breast cancer is the most common cancer among women in the urban Indian population. Around 15% of breast cancers do not express Estrogen Receptor (ER), Progesterone Receptor (PR) or Human Epidermal Growth Factor Receptor 2 (HER2) and are categorized as triple negative breast cancers (TNBC). TNBC’s show an aggressive clinical behavior and have a poor prognosis. Because of such aggressive behavior of this type of breast cancer there is an international interest in obtaining improvements in survival of these patients. Also, there is no specific guidelines available to treat metastatic TNBC. Considering the high incidence of the metastatic TNBC in India, its aggressive behavior and lack of essential data, especially in Indian settings, we propose to conduct this retrospective analysis to assess the treatment pattern and outcomes in patients with metastatic and/or recurrent TNBC. This result will form the base for future randomized control trials focusing on metastatic TNBC in India. |