| CTRI Number |
CTRI/2025/11/097991 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Survival rates after partial and total breast removal in locally advanced breast cancer |
|
Scientific Title of Study
|
Disease free survival rates of Breast Conservation and modified radical mastectomy following neoadjuvant therapy in locally advanced breast cancer patients with skin involvement (T4b): A Randomized Controlled Trial |
| Trial Acronym |
BRECON-T4b |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ephraim Rebba |
| Designation |
Assistant professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Surgical Oncology
AIIMS, Phulwarisharif, Patna, Bihar
Department of Surgical Oncology
AIIMS, Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7899087040 |
| Fax |
|
| Email |
ephraim.vanquisher18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ephraim Rebba |
| Designation |
Assistant professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Surgical Oncology
AIIMS, Phulwarisharif, Patna, Bihar
Department of Surgical Oncology
AIIMS, Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7899087040 |
| Fax |
|
| Email |
ephraim.vanquisher18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ephraim Rebba |
| Designation |
Assistant professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Surgical Oncology
AIIMS, Phulwarisharif, Patna, Bihar
Department of Surgical Oncology
AIIMS, Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7899087040 |
| Fax |
|
| Email |
ephraim.vanquisher18@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ephraim Rebba |
| Address |
Assistant Professor, Dept. of Surgical Oncology, AIIMS PATNA, Phulwarisharif, Patna, Bihar |
| Type of Sponsor |
Other [Self] |
|
|
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 Ephraim Rebba |
All India Institute of Medical Sciences, Patna |
Department of Surgical Oncology
AIIMS, Phulwarisharif, Patna, Bihar
Patna
BIHAR |
7899087040
ephraim.vanquisher18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Advisory committee AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breast conservation surgery (BCS) |
Breast conservation surgery includes excision of the breast lump, along with 1cm rim of normal tissue all around and reconstruction to achieve acceptable cosmesis. |
| Comparator Agent |
Modified radical mastectomy (MRM) |
Modified radical mastectomy includes excision of the whole breast and axillary lymph nodes up to level II. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Breast cancer patients with skin involvement (T4b) who have responded (complete, partial, and stable disease) to NACT (response assessed using the RECIST 1.1 criteria).
2. Patients willing to consent for the study
|
|
| ExclusionCriteria |
| Details |
1. Progressive disease after NACT
2. Supraclavicular nodes (N3 disease)
3. Fixed axillary nodes
4. Metastatic disease(M1 disease)
5. Poor general conditions with ECOG score of 2 or more precluding NACT or surgery or radiation with a known history of liver .cardiac and renal disease |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate disease free survival rates of breast conservation and modified radical mastectomy following neoadjuvant chemotherapy in locally advanced breast cancer patients with skin involvement |
Three years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate overall survival and ipsilateral breast tumor recurrence rates between the two surgical approaches |
Three years |
| To assess postoperative complications (30-day morbidity) using the Clavien-Dindo scoring system |
30 days |
| To study the pathological outcomes of these patients |
30 days |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
08/12/2025 |
| 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)
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
|
BRECON-T4b trial aims to determine
whether breast conservation surgery (BCS),
traditionally reserved for early breast cancers, can be a safe and effective
alternative to modified radical mastectomy (MRM) in patients
with locally advanced breast cancer with skin involvement (T4b),
who have responded to neoadjuvant chemotherapy (NACT). It seeks to answer
whether disease-free survival (DFS), ipsilateral breast tumor recurrence (IBTR), and overall survival (OS) of BCS are comparable to MRM in this subgroup. This trial challenges
the long-held belief that mastectomy is mandatory in T4b breast cancers by
prospectively comparing BCS and MRM, whether less radical surgery is
oncologically safe. |