| CTRI Number |
CTRI/2023/06/054056 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Low dose Capecitabine in Triple Negative Breast Cancer patients as maintenance in Indian Women |
|
Scientific Title of Study
|
METRONOMIC CAPECITABINE FOR MAINTENANCE IN NON METASTATIC TRIPLE NEGATIVE BREAST CANCER [TNBC] AFTER STANDARD TREATMENT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SVS Bala |
| Designation |
Associate Prof. |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre |
| Address |
Dept. of Radiation Oncology,
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre, Mullana-Ambala
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre, Mullana-Ambala (133207)
Ambala
HARYANA
133207
India |
| Phone |
9176853611 |
| Fax |
|
| Email |
balasvs109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SVS Bala |
| Designation |
Associate Prof. |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre |
| Address |
Dept. of Radiation Oncology,
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre, Mullana-Ambala
Dept. of Radiation Oncology,
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre, Mullana-Ambala
Ambala
HARYANA
133207
India |
| Phone |
9176853611 |
| Fax |
|
| Email |
balasvs109@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SVS Bala |
| Designation |
Associate Prof. |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre |
| Address |
Dept. of Radiation Oncology,
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre, Mullana-Ambala
Dept. of Radiation Oncology,
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre, Mullana-Ambala
Ambala
HARYANA
133207
India |
| Phone |
9176853611 |
| Fax |
|
| Email |
balasvs109@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Medical Sciences and Research Center, Mullana-Ambala, Haryana, India (Pin : 133207) |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre |
| Address |
Maharishi Markandeshwar Institute of Medical Sciences and Research Center, Mullana-Ambala, Haryana, India (Pin : 133207) |
| Type of Sponsor |
Private 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 SVS Bala |
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre, Mullana-Ambala |
Radiotherapy Ward No. 1, Dept. of Radiation Oncology,
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre, Mullana-Ambala
Ambala
HARYANA |
9176853611
balasvs109@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,MMIMSR, MULLANA-AMBALA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C506||Malignant neoplasm of axillary tail of breast, (2) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (3) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (4) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (5) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (6) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (7) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Tablet Capecitabine |
Tablet Capecitabine -
650 mg/m2 Twice Daily with Tablet Pyridoxine 50 mg Twice daily - Per Oral for 12 months daily (for maintenance after standard treatment) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 25 -75 yrs.
2. Karnofsky performance status more than 70
3. Completed planned standard therapy (Surgery, Chemotherapy- neoadjuvant/ adjuvant,
Radiotherapy)
4. Proven to be non metastatic after standard treatment also by imaging with whole body
PET-CT before starting tab. Capecitabine.
5. No other synchronous malignancy |
|
| ExclusionCriteria |
| Details |
1. Age <25 yrs and >75 yrs.
2. With history of treatment for Breast cancer or for any other Malignancy
3. Deranged liver and kidney functions
4. Deranged coagulation profile [bleeding time, clotting time, PT-INR]
5. Known hypersensitivity to capacitabine or 5-Flourouracil
6. Metastatic Disease at presentation or after completion of standard therapy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the tolerability & toxicities of Metronomic capacitabine as maintenance
therapy [post standard treatment] in non-metastatic TNBC patients |
Tolerability and Toxicities assessed ever month for 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the Disease free survival of these patients at 2 years |
To establish the Disease free survival of these patients at 2 years |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/07/2023 |
| 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 - YES
- What data in particular will be shared?
Response (Others) - N/A
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Response (Others) - N/A
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [balasvs109@gmail.com].
- For how long will this data be available start date provided 10-06-2025 and end date provided 10-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - N/A
|
|
Brief Summary
|
The rising cancer burden globally in general and in India in particular is a significant health
concern. Breast cancer forms a majority of this burden in females of which triple negative
molecular subtype particularly shows poor response and increased relapse rates and distant
metastases after standard combined modality approach of surgery, chemotherapy and
radiotherapy . A number of drugs are being tried in neoadjuvant, adjuvant and metastatic settings in triple negative breast cancers to cater to the huge unmet need in treatment modalities that could be offered to this notorious entity. Most of these drugs, barring a few for neoadjuvant setting, have not been able to have an established role. Capecitabine can be offered to most patients of triple negative breast cancers after standard
therapy, owing to its availability and affordability. Addition of metronomic capecitabine in
adjuvant setting after standard therapy in TNBC patients has potential particularly for developed countries like India. Ambala district has the second highest incidence of breast cancer in the state of Haryana and a single institution study from our institute showed the incidence of TNBC to be as high as 43%. This study is being taken up to assess the tolerability of metronomic capecitabine as
maintenance therapy post standard therapy in non metastatic TNBC patients while establishing the disease free survival of these patients. |