| CTRI Number |
CTRI/2024/12/078366 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Detecting Rare Cancer Cells and DNA in blood samples of Early-Stage Triple-Negative Breast Cancer After Chemotherapy |
|
Scientific Title of Study
|
Evaluation of circulating tumor DNA (ctDNA) and Circulating Tumor Cells (CTC) for detecting Minimal Residual Disease in Early-Stage Triple-Negative Breast Cancer Post-Neoadjuvant Chemotherapy. |
| Trial Acronym |
REACT is a trial Acronym.
REACT - (R)esidual (E)valuation (A)fter (C)hemotherapy in (T)NBC.
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1302-1885 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhuvan Chugh |
| Designation |
Senior Consultant – Medical Oncology |
| Affiliation |
Max Super Speciality Hospital Saket (East Block) (A unit of Devki Devi Foundation) |
| Address |
Room No.9, Department of Medical Oncology, Max Super Speciality Hospital, Saket, (East Block) (A Unit of Devki Devi
Foundation)
2, Press Enclave Road,Saket.
New Delhi
DELHI
110017
India |
| Phone |
8607773444 |
| Fax |
|
| Email |
drbhuvanchugh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhuvan Chugh |
| Designation |
Senior Consultant – Medical Oncology |
| Affiliation |
Max Super Speciality Hospital Saket (East Block) (A unit of Devki Devi Foundation) |
| Address |
Room No.9, Department of Medical Oncology, Max Super Speciality Hospital, Saket (East Block) (A Unit of Devki Devi Foundation)
2, Press Enclave Road, Saket.
New Delhi
DELHI
110017
India |
| Phone |
8607773444 |
| Fax |
|
| Email |
drbhuvanchugh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhuvan Chugh |
| Designation |
Senior Consultant – Medical Oncology |
| Affiliation |
Max Super Speciality Hospital Saket (East Block) (A unit of Devki Devi Foundation) |
| Address |
Room No.9, Department of Medical Oncology, Max Super Speciality Hospital, Saket (East Block) (A Unit of Devki Devi Foundation)
2,Press Enclave Road,
Saket.
New Delhi
DELHI
110017
India |
| Phone |
8607773444 |
| Fax |
|
| Email |
drbhuvanchugh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Company
One Cell Diagnostics
209, B Wing, GO Square,
Aundh Hinjewadi Road,
Waked, Pune - 411057,
Maharashtra, INDIA
|
|
|
Primary Sponsor
|
| Name |
OneCell Diagnostics |
| Address |
209, B Wing, GO Square, Aundh Hinjewadi Road,
Wakad, Pune - 411057, Maharashtra, INDIA
|
| Type of Sponsor |
Other [Diagnostic Company] |
|
|
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 |
| DrBhuvan Chugh |
Max Super Speciality Hospital (A Unit of Devki Devi Foundation) |
Room No.9, Department of Medical Oncology, Max Super Speciality Hospital, Saket( East Block), 2 Press Enclave Marg, Saket Institutional Area, Saket, New Delhi
New Delhi
DELHI |
8607773444
drbhuvanchugh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Devki Devi Foundation |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosis: Confirmed early-stage triple-negative breast cancer (TNBC).
Treatment: Eligible for neoadjuvant chemotherapy (NACT) for TNBC.
Age: Females 18 and above
Consent: Able and willing to provide informed consent.
Organ Function: Adequate liver, renal, and blood counts.
Follow-up Compliance: Willingness for regular follow-up and blood sampling.
Baseline Sample: Available baseline blood sample pre-NACT. |
|
| ExclusionCriteria |
| Details |
Metastatic Disease: Presence of metastatic breast cancer.
Previous Malignancies: Other malignancies within a specified recent period.
Concurrent Trials: Participation in other clinical trials with investigational drugs.
Major Health Conditions: Uncontrolled diabetes, severe cardiovascular diseases, or infections.
Pregnancy/Breastfeeding: Currently pregnant or breastfeeding.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
i. Pathological Complete Response (pCR)
ii. Overall Survival (OS)
iii. Progression-Free Survival (PFS):
iv. Disease-Free Survival (DFS): |
3 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Recurrence Rate
ii. CTC and ctDNA Levels Correlation with Survival Outcomes
iii. Time to Recurrence
iv. Biomarker Dynamics |
3 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/02/2025 |
| 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="3"
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
|
This study is single centered, Observational, Longitudnal, Cohort study The primary purpose of this observational study is to evaluate the effectiveness of neoadjuvant chemotherapy (NACT) in patients with early-stage triple-negative breast cancer (TNBC) by assessing primary outcomes such as pathological complete response (pCR), overall survival (OS), progression-free survival (PFS), and disease-free survival (DFS). Additionally, the study aims to investigate the correlation between circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) levels post-NACT with disease progression. These biomarkers will be evaluated for their potential to serve as reliable indicators of NACT efficacy and predictors of short-term clinical outcomes in early-stage TNBC patients. |