| CTRI Number |
CTRI/2024/01/061482 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
To study the difference in outcomes in Estrogen or Progestrone positive breast cancer patients with HER2 low vs HER2 negative status. |
|
Scientific Title of Study
|
Impact of HER2 Low on demographic profile and survival outcomes of Hormone positive breast cancer (HER- IMPACT). |
| 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 |
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
Scientific Query
|
| Name |
Dr Sudeep Gupta |
| Designation |
Professor Medical Oncology, Director TMC |
| Affiliation |
Tata Memorial Center |
| Address |
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 |
Room No:1109,
11 floor,
Homi Bhabha Building.
Tata Memorial Hospital
E Borges Marg.
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09967594597 |
| Fax |
02224177201 |
| Email |
yogeshkembhavi1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
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) |
Department of Medical Oncology
Department of Surgical Oncology
Room no 106, First floor
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 Centre |
Department of Medical Oncology
Department of Surgical Oncology
1109,11 floor.
Homi Bhabha Building.
Tata Memorial Hospital
E Borges Marg
Parel , 400012
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 |
15.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Histologically confirmed invasive ductal carcinoma (IDC) breast, with the following specifications:
- Age: 15 years and above
- Females
- Diagnosed between 1st January 2015 and 31st December 2020
- Estrogen receptor (ER) or Progesterone receptor (PR) positive by IHC
- HER2 by IHC: Zero (0) or One plus (1+) or
- HER2 by IHC: Two plus (2+) and HER-2 gene amplification by FISH: non-amplified |
|
| ExclusionCriteria |
| Details |
1 Ductal carcinoma in-situ DCIS
2 Lobular carcinoma
3 Triple negative breast cancer ER, PR and HER2 negative by IHC
4 HER2 positive by IHC
5 HER2 by IHC: Two plus and HER2 gene amplification by FISH amplified equivocal uninterpretable or not done |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the overall survival in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm. |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the DFS in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm in the curative setting.
2. To evaluate the PFS in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm in the metastatic setting.
3. To evaluate the differences in the demographic profile in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm. |
5 years |
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="5000"
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)
|
18/01/2024 |
| 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
|
Patients with histologically proven hormone-positive breast cancer who meet the eligibility criteria will be included in the study. The following baseline parameters will be recorded: age, co-morbidities, ER, PR and HER-2 scores by IHC, HER-2 gene amplification by FISH result if HER-2 by IHC = 2+, tumour laterality, clinical tumour, nodal and metastatic staging (cTNM) as per American Joint Committee on Cancer (AJCC) eighth edition, whether operable breast cancer (OBC), locally advanced breast cancer (LABC) or metastatic breast cancer (MBC). Further, details on neo-adjuvant chemotherapy, type of surgery, pathological grade of tumour, pathological tumour and nodal staging (pTNM), adjuvant chemotherapy, radiotherapy and hormonal therapy will be recorded. Follow-up details including the dates of progression, sites of metastases and the therapy received on progression shall also be recorded. |