| CTRI Number |
CTRI/2026/01/102272 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study of Chemotherapy With or Without Enzalutamide in Patients With Androgen Receptor-Positive Triple-Negative Metastatic Breast Cancer. |
|
Scientific Title of Study
|
Chemotherapy with Enzalutamide or placebo in patients with androgen receptor positive, triple-negative metastatic breast cancer: A randomized phase II/III trial. |
| Trial Acronym |
ICEBERG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushmita Rath |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Medical Oncology Department, Room no.1005, 10th Floor, Homi Bhabha Block, Tata Memorial Hospital, Parel (East), Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09869154396 |
| Fax |
|
| Email |
sushmitarath73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushmita Rath |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Medical Oncology Department, Room no.1005, 10th Floor, Homi Bhabha Block, Tata Memorial Hospital, Parel (East), Mumbai.
MAHARASHTRA
400012
India |
| Phone |
09869154396 |
| Fax |
|
| Email |
sushmitarath73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushmita Rath |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Medical Oncology Department, Room no.1005, 10th Floor, Homi Bhabha Block, Tata Memorial Hospital, Parel (East), Mumbai.
MAHARASHTRA
400012
India |
| Phone |
09869154396 |
| Fax |
|
| Email |
sushmitarath73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Zydus Lifesciences, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Near Vaishnodevi Circle, S.G. Highway, Ahmedabad, Gujarat, India, Pincode: 382481 |
|
|
Primary Sponsor
|
| Name |
Zydus Lifesciences |
| Address |
Zydus Corporate Park, Scheme No. 63, Survey No. 536 Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, SG Highway, Ahmedabad – 382481, Gujarat |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tata Memorial Hospital |
Dr. Ernest Borges Road, Parel, Mumbai - 400012 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushmita Rath |
Tata Memorial Hospital |
Medical Oncology Department,Breast division, Room no.1005, 10th Floor, Homi Bhabha Block, Tata Memorial Hospital, Parel (East), Mumbai.
Mumbai
MAHARASHTRA |
09869154396
sushmitarath73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee I |
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 |
Enzalutamide 160mg Obynx + Chemotherapy |
Chemotherapy includes (Capecitabine, Paclitaxel / Nab-paclitaxel, Gemcitabine, Eribulin)
Enzalutamide is initiated on Day 1 of chemotherapy and continued until disease progression, unacceptable toxicity, or patient withdrawal. |
| Comparator Agent |
Placebo + Chemotherapy |
Chemotherapy includes (Capecitabine, Paclitaxel / Nab-paclitaxel, Gemcitabine, Eribulin) Placebo is initiated on Day 1 of chemotherapy and continued until disease progression, unacceptable toxicity, or patient withdrawal.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects must have histologically or cytologically confirmed invasive breast carcinoma.
Disease must be locally advanced unresectable or metastatic breast cancer.
Tumor must be triple negative breast cancer defined as estrogen receptor and progesterone receptor less than one percent by immunohistochemistry and HER2 negative defined as HER2 IHC 0 or 1 plus or IHC 2 plus with FISH negative.
Tumor must be androgen receptor positive defined as androgen receptor expression greater than or equal to ten percent by immunohistochemistry.
Subjects must be chemotherapy naive for the advanced or metastatic setting.
Eastern Cooperative Oncology Group performance status must be zero to two.
Subjects must have adequate hematologic hepatic renal and pulmonary function as defined in the protocol.
Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during treatment and for the protocol specified period after treatment.
Male subjects with partners of childbearing potential must agree to use effective contraception during treatment and for the protocol specified period after treatment.
Subjects must be able to understand and willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Subjects receiving any other concurrent investigational agents are excluded.
Subjects previously exposed to anti androgen therapy after the diagnosis of breast cancer are excluded.
Subjects with symptomatic brain metastases or brain metastases requiring active treatment are excluded.
Subjects with active infection requiring systemic therapy are excluded.
Subjects with hepatitis B virus infection with positive surface antigen and elevated HBV DNA or hepatitis C virus infection with positive anti HCV antibody and elevated HCV RNA are excluded.
Subjects with known severe hypersensitivity to the investigational product or any component of its formulation are excluded.
Subjects with clinically significant active cardiovascular disease including unstable angina congestive heart failure New York Heart Association class two or higher serious uncontrolled cardiac arrhythmia or asymptomatic individuals with left ventricular ejection fraction less than fifty percent are excluded.
Subjects with other severe acute or chronic medical conditions including inflammatory bowel disease pneumonitis chronic kidney disease chronic liver disease pulmonary fibrosis known peripheral neuropathy greater than grade one as per CTCAE version five or significant psychiatric illness including recent or active suicidal ideation or behavior are excluded.
Pregnant women are excluded from the study.
Subjects with any other concomitant malignancy within the last five years except adequately treated basal cell carcinoma squamous cell carcinoma of the skin or carcinoma in situ of the cervix are excluded. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Phase II Primary Outcome:
Progression Free Survival defined as the time from the date of randomization to the date of documented disease progression as per RECIST version 1.1 or death from any cause whichever occurs first.
Phase III Primary Outcome:
Overall Survival defined as the time from the date of randomization to death from any cause or last follow up for surviving patients. |
Baseline and every 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall Response Rate (ORR)
Clinical Benefit Rate (CBR)
Safety and Tolerability
Quality of Life (QOL) |
ORR and CBR assessed every 12 weeks from randomization |
|
|
Target Sample Size
|
Total Sample Size="387"
Sample Size from India="387"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/02/2026 |
| 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="0"
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 - NO
|
|
Brief Summary
|
This is a multicentre randomized parallel group placebo controlled Phase II and Phase III clinical trial designed to evaluate the efficacy and safety of adding enzalutamide to standard chemotherapy in patients with androgen receptor positive triple negative locally advanced or metastatic breast cancer. Eligible patients aged eighteen years and above will be randomized in a one to one ratio to receive either enzalutamide with chemotherapy or placebo with chemotherapy. Chemotherapy will be selected by the treating physician from predefined standard regimens. The Phase II component will assess progression free survival and if efficacy criteria are met the study will continue to the Phase III component to assess overall survival. Secondary objectives include evaluation of overall response rate clinical benefit rate safety tolerability and quality of life. Treatment will continue until disease progression unacceptable toxicity or patient withdrawal with regular follow up for efficacy and survival outcomes. |