| CTRI Number |
CTRI/2025/01/079814 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing a New Treatment Combining Chemotherapy and Radiation Before Surgery for Advanced Triple-Negative Breast Cancer |
|
Scientific Title of Study
|
Neoadjuvant Concurrent Chemoradiation Therapy in the Locally Advanced Triple-Negative Breast Cancer Population: A Prospective Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jahnabi Das |
| Designation |
Assistant Professor |
| Affiliation |
Dr B Borooah Cancer Institute |
| Address |
Department of Radiation Oncology,
Dr B Borooah Cancer Institute
Guwahati
Kamrup
ASSAM
781016
India |
| Phone |
6901269033 |
| Fax |
03612472636 |
| Email |
jahnabi.das@bbci.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jahnabi Das |
| Designation |
Assistant Professor |
| Affiliation |
Dr B Borooah Cancer Institute |
| Address |
Department of Radiation Oncology,
Dr B Borooah Cancer Institute
Guwahati
Kamrup
ASSAM
781016
India |
| Phone |
6901269033 |
| Fax |
03612472636 |
| Email |
jahnabi.das@bbci.in |
|
Details of Contact Person
Public Query
|
| Name |
Jahnabi Das |
| Designation |
Assistant Professor |
| Affiliation |
Dr B Borooah Cancer Institute |
| Address |
Department of Radiation Oncology,
Dr B Borooah Cancer Institute
Guwahati
Kamrup
ASSAM
781016
India |
| Phone |
6901269033 |
| Fax |
03612472636 |
| Email |
jahnabi.das@bbci.in |
|
|
Source of Monetary or Material Support
|
| INTRAMURAL FUND will be provided by Dr B Borooah Cancer Institute, Gopinath Nagar,Guwahti-781016,Assam, India
where the trial will be conducted |
|
|
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 JAHNABI DAS |
DR B BOROOAH CANCER INSTITUTE |
Department of Radiation Oncology
Kamrup
ASSAM |
6901269033
jahnabi.das@bbci.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Ethics Committee, BBCI |
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 |
Neoadjuvant chemoradiation in locally advanced triple negative breast cancer patients |
4 cycles of 3 weekly chemotherapy with anthracycline cyclophosphamide followed by 12 weekly cycles with taxanes. Along with 9th cycle of taxane radiation will be started followed by modified radical mastectomy after 6 weeks of completion of neoadjuvant chemo radiation |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Biopsy proven unilateral locally advanced triple negative breast cancer which includes Stage IIIA-C &/or oligometastastic disease which is defined by ESTRO/ESMO/ACOG as a disease with up to 5 lesions each amenable to local therapy aimed at achieving no evidence of disease status. |
|
| ExclusionCriteria |
| Details |
Unwilling for mastectomy, previous irradiation to chest wall, multiple visceral/bone metastasis, renal cardiac dysfunction, uncontrolled diabetes, bilateral breast cancer, recurrence of tumour |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the tolerability of treatment regimen |
Patient will be assessed at baseline, during time of chemoradiation, post surgery,and after treatmet at 6 weeks, 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess pathological complete response rate (pCR) |
pCR report will be available only post surgery (after completion of treatment i.e Neoadjuvant chemoradiation followed by modified radical mastectomy) single time point |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This research explores how well a combination of chemotherapy and radiation therapy works in treating triple-negative breast cancer when given before surgery |