| CTRI Number |
CTRI/2024/12/078269 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Identification of factors predicting complete response to neo-adjuvant chemotherapy in breast cancer patients |
|
Scientific Title of Study
|
Development of predictive nomogram for assessing pathological complete response after neo-adjuvant chemotherapy in treatment naive non-metastatic breast cancer patients - An ambispective study |
| Trial Acronym |
P-NNACLE-B
(P-Predictive
N-Nomogram
post
N-Neo
A-Adjuvant
C-Chemotherapy
in
L-Locally advanced
and
E-Early
B-Breast cancer)
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suhani |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 414, Surgery Block, AIIMS Delhi Campus, Ansari Nagar East
New Delhi
DELHI
110029
India |
| Phone |
01126551815 |
| Fax |
|
| Email |
drsuhani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramita Mukherjee |
| Designation |
Senior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Surgical Disciplines, 4th floor, AIIMS Delhi Campus
New Delhi
DELHI
110029
India |
| Phone |
7604052439 |
| Fax |
|
| Email |
drramitamukherjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramita Mukherjee |
| Designation |
Senior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Surgical Disciplines, 4th floor, AIIMS Delhi Campus
New Delhi
DELHI
110029
India |
| Phone |
7604052439 |
| Fax |
|
| Email |
drramitamukherjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
All India Institute of Medical Sciences, New Delhi
Ansari Nagar East,
New Delhi 110029
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Suhani |
All India Institute of Medical Sciences |
Room 414, 4th floor, Department of Surgical Disciplines, Surgery Block, AIIMS Delhi Campus, Ansari Nagar East
New Delhi 110029
New Delhi
DELHI |
01126551815
drsuhani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee AIIMS OT Block Ansari Nagar, New Delhi 29 |
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 |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Treatment naïve non-metastatic breast cancer patients receiving/received
neoadjuvant chemotherapy
2. For prospective group: patients consenting to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Breast cancer patients with previous history of surgery or radiotherapy to chest and
axilla.
2. Metastatic breast cancer at presentation.
3. Patients not consenting to participate in the study.
4. Patients having incomplete records. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To develop a predictive nomogram to predict pathological complete response in treatment naïve non metastatic breast cancer patients receiving neoadjuvant
chemotherapy |
From enrollment to final histopathology (06 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To validate the predictive nomogram developed to identify the patients having a
likelihood of achieving pathological complete response in treatment naïve non
metastatic breast cancer patients receiving neoadjuvant chemotherapy |
01 month |
To study the factors predicting pathological complete response in treatment naïve
non metastatic breast cancer patients receiving neoadjuvant chemotherapy |
06 months |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
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)
|
30/12/2024 |
| 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="6"
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
|
Breast cancer is the most common malignancy in women and leading cause of cancer related deaths amongst them. There is a difference in the clinical and demographic presentation of breast cancer patients in India compared to the West. Asians are younger to Western women with breast cancer at time of diagnosis. Prevalence of Triple negative breast cancer is more in Indian than Western women. Hence, the predictors of desired response to chemotherapy are also expected to differ. No study has been carried out in the Indian subcontinent to identify the predictors of complete response to chemotherapy in breast cancer patients. There is a striking difference in the clinical and demographic profile of breast cancer patients from India and the west. There is no published study in English literature from Indian sub continent on this subject. The few available studies from the west have used differing parameters as marker for response assessment making a head on comparison difficult. Hence, we wish to study the factors influencing response to Neoadjuvant chemotherapy and develop a predictive nomogram for the same. This may help in individualized patient treatment planning in the future. |