| CTRI Number |
CTRI/2025/08/092443 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A real-world study on how well ribociclib and hormone therapy work together to prevent early breast cancer from coming back. |
|
Scientific Title of Study
|
A phase IIIb study to characterize the efficacy and safety of Adjuvant ribociclib plus endocrine therapy in a close to clinical practice patient population with HR positive HER2 negative early
breast cancer (Adjuvant WIDER) |
| Trial Acronym |
Adjuvant WIDER |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2022-503001-38 |
EudraCT |
| CLEE011O12001, Amendment 02 dated 08 Jan 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murugananthan K |
| Designation |
SSO Country Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 7 floor Inspire BKC G
Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murugananthan K |
| Designation |
SSO Country Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 7 floor Inspire BKC G
Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Murugananthan K |
| Designation |
SSO Country Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 7 floor Inspire BKC G
Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Novartis Campus 4056 – Basel, Switzerland |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla
Complex, Bandra (East), Mumbai – 400051,India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Brazil
Canada
France
Germany
Hong Kong
India
Israel
Italy
Mexico
Portugal
Republic of Korea
Spain
Taiwan
Turkey
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr MVT Krishna Mohan |
Basavatarakam Indo American Cancer Hospital and Research Insititute |
Department of Medical Oncology, Basavatarakam Indo American Cancer Hospital and Research Insititute, Road No 10, Banjara Hills, Hyderabad 500034
Hyderabad
TELANGANA |
9866154503
mvtkm@yahoo.com |
| Dr Ajay Gogia |
All India Institute of Medical Sciences (AIIMS) |
Room No218, Second Floor, Department of Medical Oncology, Dr. B.R.A, I.R.C.H, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029
New Delhi
DELHI |
9013000642
ajaygogia@gmail.com |
| Dr Rejiv Rajendranath |
Apollo Cancer Centre |
No.320, Padma complex,
Anna Salai Chennai-600035,
Tamil Nadu, India.
Chennai
TAMIL NADU |
4424355003
rejivr@yahoo.co.in |
| Dr Joydeep Ghosh |
Apollo Multispeciality Hospitals Limited |
58,Canal Circular Road, Kolkata- 700054
West Bengal,
India
Kolkata
WEST BENGAL |
9167874217
dr.joydeep.ghosh@gmail.com |
| Dr Chirag Desai |
Hemato Oncology Clinic Pvt Ltd |
Nirmaya Complex Ground Floor to Third Floor BS Pandit Dindayal Auditorium Rajpath Club Road Off SG Highway Ahmedabad 380054
Ahmadabad
GUJARAT |
917929706719
chiragdesai.oncology@gmail.com |
| Dr Amit Rauthan |
Manipal Hospital |
98 Old Airport Road Bangalore 560017 Karnataka India
Bangalore
KARNATAKA |
9880463958
amit.rauthan@manipalhospitals.com |
| Dr Shona Milon Nag |
Sahyadri Super Speciality Hospital |
Hadapsar,
Sr. No. 163, Bhosale Nagar, Hadapsar Pune-411028, Maharashtra, India
Pune
MAHARASHTRA |
9371072441
shonanag3@gmail.com |
| Prof Dr Ghanashyam Biswas |
Sparsh Hospital and Critical Care (P) Ltd |
A 407 Saheed Nagar Bhubaneswar Odisha India 751007
Baleshwar
ORISSA |
916742540183
drgbiswas@gmail.com |
| Dr Prabhat Bhargava |
Tata Memorial Hospital |
Room no: 1106, Homi Bhabha Building, Tata Memorial Hospital, Dr. Ernest Borges Road. Parel, Mumbai-400012
Mumbai
MAHARASHTRA |
91-22-24177000
bhargava611@gmail.com |
| Dr Kaushal Kalra |
VMMC and Safdarjung Hospital |
Room no 404, 4th floor, Old SIC, Department of medical oncology, VMMC and Safdarjung Hospital, New Delhi-110029
New Delhi
DELHI |
9968663394
kaushalkalra@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospital-Dr. Amit Rauthan |
Approved |
| Institute Ethics Committee, AIIMS-Dr Ajay Gogia |
Approved |
| Institutional Ethics Committee (IEC)-1-Tata Memorial Centre-Dr. Prabhat Bhargava |
Approved |
| Institutional Ethics Committee, Apollo Multispeciality Hospitals Limited- Dr. Joydeep Ghosh |
Approved |
| Institutional Ethics Committee, Basavatarakam Indo American Cancer Hospital and Research Insititute-Dr M VT Krishna Mohan |
Approved |
| Institutional Ethics Committee, Sparsh Hospital-Dr Ghanashyam Biswas |
Approved |
| Institutional Ethics Committee-Clinical Studies,Apollo Hospitals Enterprise Limited-Dr. Rejiv Rajendranath |
Approved |
| Institutional Ethics Committee-Dr Kaushal Kalra- |
Submittted/Under Review |
| Marengo Asia Healthcare Pvt Ltd_Dr. Chirag Desai |
Approved |
| Sahyadri Hospitals PVT Ltd Ethics Committee--Dr Shona Milon Nag. |
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 |
NA |
NA |
| Intervention |
ribociclib |
400 mg once daily in a 3 weeks on or 1 week off in combination with endocrine therapy for 36 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Approximately 2800 participants will have breast cancer that is stage III, stage IIB or IIA meeting certain criteria, and approximately 300 participants will have high risk Stage I breast cancer. To qualify to join the study, participants must have at least 3 years remaining of standard hormone therapy, which is the duration of treatment on study. |
|
| ExclusionCriteria |
| Details |
Participants cannot be on any other anti-cancer therapy, be pregnant or breast feeding, or plan to become pregnant during the trial. Participants must not have any uncontrolled medical condition, including heart conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The main question this trial is designed to answer is if early breast cancer participants receiving ribociclib in combination with hormonal therapy have the cancer coming back after 3 years using STEEP (Standardized Definition for Efficacy Endpoints in Adjuvant Breast Cancer Clinical Trials) by Investigators |
Your Study Doctor will assess if there are any signs of tumor growth in the breast tissue or other parts of the body. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
If ribociclib plus hormonal therapy is safe
|
Number and severity of side effects (adverse events) until 30 days after the end of treatment
|
| If and when participants cancer comes back including breast and or new cancer |
Every 3 cycles starting from Cycle 1 Day 1 during the first 24 months
and every 6 cycles thereafter until confirmation of distant recurrence
|
| If and when participants breast cancer spreads to other parts of the body |
Within 4 weeks after clinical suspicion of recurrence |
| How long does it take from start of treatment until the return of participants breast cancer if applicable |
Every 3 cycles starting from Cycle 1 Day 1 during the first 24 months
and every 6 cycles thereafter until confirmation of distant recurrence |
| How concentrated the ribociclib dose was |
Once daily on days 1 to 21 of each 28-day cycle for 39 cycles from C1D1
|
| If and when participants stop taking ribociclib |
Continuous up to 30 days after last dose of study treatment |
| How many participants are still alive from the start to the end of the study. |
Rate at which participants die until end of the study |
| How participants feel and manage daily life when taking ribociclib plus hormonal therapy and after until their cancer returns or until end of the study |
Every 3 cycles from C1D1 during the first 24 months every 6 cycles thereafter until 12 months after confirmation of distant recurrence At EoT and every recurrence unless within 4 weeks of last PRO assessment |
|
|
Target Sample Size
|
Total Sample Size="3100"
Sample Size from India="210"
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 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/01/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="6"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Cancer is a well-known condition where abnormal cells in the body
begin to grow and divide uncontrollably. Different stages of cancer are defined
by the location of the cancerous cells and whether they have spread to other areas
in the body. Patients with early breast cancer have minimal spread to other
parts of the body. Although many patients may be declared disease-free after cancer
treatment, early breast cancer patients still have a risk of the cancer coming
back after the first diagnosis.
The purpose of this trial is to evaluate if the study drug, ribociclib,
when added to the standard of care hormonal treatment, can help reduce the risk
of breast cancer returning in these patients.
Ribociclib is a drug designed to lower the activity of certain proteins
in the body that control when cells divide. Blocking these proteins slows down
the rate at which abnormal cells divide to create new tumors in the body. This
trial is designed to find out if ribociclib in combination with hormonal
therapy in participants with early breast cancer can maintain early breast
cancer participants’ disease free. The trial is also designed to learn more
about the safety of ribociclib.
|