| CTRI Number |
CTRI/2024/05/066872 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Benefit of oral chemotherapy drug Capecitabine by comparing two different dose schedules with observation after standard treatment in triple negative Breast Cancer |
|
Scientific Title of Study
|
Evaluating the role of Adjuvant Capecitabine by comparing two different dose schedules with observation after standard treatment in triple negative Breast Cancer |
| 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 Shailley |
| Designation |
Associate Professor |
| Affiliation |
Pt B D Sharma Postgraduate Institute of Medical Sciences |
| Address |
Regional Cancer Center
Department of Radiation Oncology
Pt B D Sharma Postgraduate Institute of Medical Sciences, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708536926 |
| Fax |
|
| Email |
pranjal.shailley@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailley |
| Designation |
Associate Professor |
| Affiliation |
Pt B D Sharma Postgraduate Institute of Medical Sciences |
| Address |
Regional Cancer Center
Department of Radiation Oncology
Pt B D Sharma Postgraduate Institute of Medical Sciences, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708536926 |
| Fax |
|
| Email |
pranjal.shailley@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailley |
| Designation |
Associate Professor |
| Affiliation |
Pt B D Sharma Postgraduate Institute of Medical Sciences |
| Address |
Regional Cancer Center
Department of Radiation Oncology
Pt B D Sharma Postgraduate Institute of Medical Sciences, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708536926 |
| Fax |
|
| Email |
pranjal.shailley@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt B D Sharma Postgraduate Institute of Medical Sciences,Rohtak(Haryana)-124001,India |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma Postgraduate Institute of Medical Sciences |
| Address |
Regional Cancer Center
Pt B D Sharma Postgraduate Institute of Medical Sciences,Rohtak(Haryana)-124001,India |
| Type of Sponsor |
Government medical college |
|
|
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 Shailley |
Pt. BD Sharma Postgraduate Institute of Medical Sciences |
Outpatient clinic, Department of Radiation Oncology, Regional Cancer center,Pt. BD Sharma Postgraduate Institute of Medical Sciences
Rohtak
HARYANA |
8708536926
pranjal.shailley@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee,Pt. B. D.Sharma PGIMS/UHS, Rohtak |
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 |
Capecitabine in different schedule (group B) |
Capecitabine 1000 mg/m2 day 1 to 14 followed by 1 week rest for 1 year |
| Intervention |
Comparing two different schedules of capecitabine groups (A and B) with observation group (C) |
Capecitabine at a dose of 650 mg/m2 twice a day by mouth for 1 year without interruption (group A) after receiving Standard treatment for Triple negative Carcinoma Breast |
| Comparator Agent |
Observation (Group C) |
No Adjuvant chemotherapy after standard Treatment in Triple negative Breast cancer patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with confirmed histopathological diagnosis of triple negative breast cancer (defined as estrogen or progesterone receptor 1+ or 2+ immunohistochemistry intensity in ≤ 10% cells and HER2-negative by immunohistochemistry and/or in situ hybridization)
2)Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 (Annexure I) and complete hemogram, renal and liver function tests are within normal limits
3)Patients who are able to give consent.
4)Patients must have completed work up and staging followed by treatment with standard chemotherapy and surgery and /or radiation therapy.
|
|
| ExclusionCriteria |
| Details |
1)The presence of cancer in bilateral breasts or metastatic disease, other malignant conditions or synchronic multiple cancers.
2)ECOG PS 3 and above.
3)Patients’ refusal.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison in disease-free survival |
At the end of 1-,3- and 5-years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison in Overall survival and Adverse effects between three groups |
At the end of 1-,3- and 5-years |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Breast cancer as per Globocan 2020 is the most common cancer globally and known for its heterogeneity.Triple negative breast cancer (TNBC) accounts for approximately 15% of breast cancer cases. Despite newer developments in neoadjuvant/adjuvant chemotherapy prognosis remains a big question mark with 25-35% of the patients developing metastasis within 5 years from diagnosis in TNBC patients. Capecitabine, a pro-drug of 5- fluorouracil, is an oral chemotherapeutic anti metabolite group of agent which is readily available and its role after standard treatment is yet to establish.Thus we planned to study the benefit in terms of Disease-free and overall survival and adverse effects in TNBC patients. Studies are scarce in this context and no established dose schedule especially in India,the aim will be to compare three groups with two different schedules of Capecitabine with observation group. It is a single center randomized controlled trial and the primary end point will be disease-free survival and Secondary end points will include overall survival, and adverse events.
|