| CTRI Number |
CTRI/2025/08/092935 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Chemotherapy Schedules Before Surgery in Patients with Triple-Negative Breast Cancer |
|
Scientific Title of Study
|
A Phase II Randomized Controlled Trial Comparing Alternating Versus Sequential Dose-Dense AC and Taxane Chemotherapy in the Neoadjuvant Treatment of 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 Atul Batra |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science, New Delhi |
| Address |
Room 160 D, 1st floor, IRCH, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9013078407 |
| Fax |
|
| Email |
batraatul85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Batra |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science, New Delhi |
| Address |
Room 160 D, 1st floor, IRCH, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9013078407 |
| Fax |
|
| Email |
batraatul85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Batra |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science, New Delhi |
| Address |
Room 160 D, 1st floor, IRCH, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9013078407 |
| Fax |
|
| Email |
batraatul85@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India Pincode: 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi |
| Address |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India Pincode: 110029 |
| 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 Atul Batra |
All India Institute of Medical Science, New Delhi |
Room 160 D, 1st floor, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar Pincode: 110029
New Delhi
DELHI |
09013078407
batraatul85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Old OT Block, Room No. 102, AIIMS Hospital Ansari Nagar, New Delhi-29 New Delhi South Delhi - 110029 India |
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 |
Alternating AC–T Schedule |
alternating cycles of:
o EC: Epirubicin 90mg/m² + Cyclophosphamide 600 mg/m² on Day 1
o T: Paclitaxel 175 mg/m² on Day 1
• Administered every 2 weeks × 8 total cycles (4 AC, 4 T), alternating with GCSF support .
|
| Comparator Agent |
Standard Sequential AC-T Schedule |
• 4 cycles of AC (as above), followed by
• 4 cycles of T (as above), every 2 weeks with G-CSF support.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Histologically confirmed triple negative breast cancer (ER negative PR negative HER2 negative) and Stage I to III.
•Planned for neoadjuvant chemotherapy with AC and not affordable for immunotherapy.
•ECOG performance status 0 to 1.
•Adequate bone marrow, renal, hepatic and cardiac function.
•Written informed consent provided. |
|
| ExclusionCriteria |
| Details |
•Prior chemotherapy or radiotherapy.
•Pre existing neuropathy assessed by nerve conduction study.
•Uncontrolled diabetes (HbA1c more than 8)
•Active or uncontrolled infection or significant comorbidity interfering with protocol compliance.
•Pregnant or breastfeeding women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Change in global quality of life (QoL) from baseline to the end of chemotherapy, measured using the EORTC QLQ-C30 questionnaire. |
1. Change in global quality of life (QoL) from baseline to the end of chemotherapy, measured using the EORTC QLQ-C30 questionnaire. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence & severity of peripheral neuropathy, assessed using |
Patient-reported outcomes via the CIPN20 questionnaire estimated at baseline, after 6 weeks, & after 14 weeks.
Objective evaluation through nerve conduction studies (NCS) at baseline & at the end of chemotherapy after 14 weeks. |
| Overall toxicity profile, assessed clinically at the end of each chemotherapy cycle and graded using CTCAE v5.0. |
|
| Treatment completion rates, defined as the proportion of patients completing all 8 planned chemotherapy cycles without dose reductions or delays. |
|
| Pathological complete response (pCR) rates, defined as the absence of invasive cancer in the breast and axillary nodes (ypT0/is, ypN0) at the time of definitive surgery, compared between the two arms. |
|
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A single-center, two-arm,
parallel-design, randomized controlled trial comparing an alternating
versus standard sequential chemotherapy schedule of
doxorubicin–cyclophosphamide (AC) and paclitaxel (T) in patients with
early-stage triple-negative breast cancer (TNBC). The trial aims to assess
whether the alternating schedule improves quality of life (QoL) and neuropathy
outcomes compared to the standard sequential approach.
A total of 72 patients will be
randomized in a 1:1 ratio (36 per arm) to receive either the standard
sequential AC – T regimen or an alternating AC–T schedule. Treatment will be
administered in a dose-dense format (every 2 weeks) with G-CSF support.
QoL will be assessed using
validated questionnaires at three key time points: baseline (pre-treatment),
post-cycle 4 (mid-chemotherapy), and post-cycle 8 (end of chemotherapy).
Peripheral neuropathy will be evaluated through both patient-reported outcomes
and nerve conduction studies (NCS). Toxicity will be assessed clinically after
each cycle and graded using CTCAE v5.0. |