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CTRI Number  CTRI/2024/07/070945 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 15/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   Study to Assess the Safety of Trastuzumab Deruxtecan in Indian Patients with Unresectable or Metastatic Her2- Positive Breast Cancer who have received a Prior Anti- Her2 Based treatment.  
Scientific Title of Study   A Prospective, Multi-Center, Phase 4, Single Arm Study to assess the Safety of Trastuzumab Deruxtecan, an Anti-HER2-Antibody Drug Conjugate in Indian Patient with Unresectable or Metastatic HER2-Positive Breast Cancer who have received a prior Anti-HER2-based regimen. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
D9673L00012 Version 1.0 Dated 13 September 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Kirtan Bhatt 
Designation  Medical Advisor 
Affiliation  AstraZeneca Pharma India Ltd 
Address  AstraZeneca Pharma India Ltd Block N1,12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9886266442  
Fax    
Email  kirtan.bhatt@astrazeneca.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Sachin Changan 
Designation  Project Manager- Trials and Publications 
Affiliation  AstraZeneca Pharma India Ltd 
Address  AstraZeneca Pharma India Ltd Block N1,12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9969940436  
Fax    
Email  sachin.changan@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca Pharma India Ltd. Block N1,12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, Bangalore, Karnataka, India- 560045 
 
Primary Sponsor  
Name  AstraZeneca Pharma India Ltd 
Address  Block N1,12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, Bangalore 560045, INDIA.  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Gogia  All India Institute of Medical Sciences  Department of Medical Oncology, Dr B.R.A, I.R.C.H, AIIMS, Ansari Nagar, New Delhi, 110029
New Delhi
DELHI 		 9013000642

ajaygogia@gmail.com 
Dr K Pavithran  Amrita Institute of Medical Sciences  Department of Medical Oncology and Haematology, Ponekkara Road, Edapally, Kochi, Ernakulam- 682041
Ernakulam
KERALA 		 9895367090

pavithrank@aims.amrita.edu 
Dr Akhil Kapoor  Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) and Homi Bhabha Cancer Hospital (HBCH)  Department of Medical Oncology, Sunder Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi- 221005
Varanasi
UTTAR PRADESH 		 9950482121

kapoorakhil1987@gmail.com 
Dr Amit Rauthan  Manipal Hospital  Department of Medical Oncology, HAL Old Airport Road, Kodihalli, Bengaluru- 560017
Bangalore
KARNATAKA 		 9880463958

amit.rauthan@manipalhospitals.com 
Dr Shona Nag  Sahyadri Super Speciality Hospital  Department of Medical oncology, SN 163, Bhosale Garden Rd, beside Bhosale Nagar, Aru Nagar, Laxmi Vihar, Hadapsar, Pune-411028
Pune
MAHARASHTRA 		 9371072441

shonanag3@gmail.com 
Dr Sudeep Gupta  Tata Memorial Hospital  Department of Medical oncology, Homi Babha Building, Dr Ernest Borges Rd, Parel East, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA 		 9821298642

sudeepgupta04@yahoo.com 
Dr Kaushal Kalra  VMMC and Safdarjung Hospital  Department of Medical Oncology, Safdarjung Campus, Ansari Nagar, New Delhi-110029
New Delhi
DELHI 		 9968663394

kaushalkalra1979@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals  Approved 
Institute Ethics committee All India Institute of Medical Sciences  Approved 
Institutional Ethics Committee Amrita Institute of Medical Sciences  Approved 
Institutional Ethics Committee for Sahyadri Hospital  Approved 
Institutional Ethics Committee of Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) and Homi Bhabha Cancer Hospital (HBCH)  Approved 
Institutional Ethics Committee of VMMC and Safdarjung Hospital  Approved 
Institutional Ethics Committee, Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  Not Applicable  Not Applicable 
Intervention  Trastuzumab Deruxtecan (Enhertu)  Dose :5.4 mg/kg Frequency: 21 day cycle for 9 cycles Route of administration :IV infusion Total duration: 9 cycles 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Participant must be more than 18 years of age inclusive, at the time of signing the informed consent.
2. Patients who are willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form.
3. Participants with pathologically documented breast cancer that:
- is unresectable or metastatic
- HER2-positive expression (IHC 3 positive or IHC 2 positive with ISH positive) as confirmed by laboratory assessment within last 1 year of study enrolment.
- was previously treated with an anti HER-2 based regimen
4. Adequate bone marrow function, within 14 d before enrolment
5. Adequate renal function within 14 d before enrolment.
6. Adequate hepatic function within 14 d before enrolment.
7. Adequate hepatic function within 14 d before enrolment.
8. Female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 mo after the last dose of trastuzumab deruxtecan. Male subjects must agree to inform all potential female partners that they are participating in a clinical trial of a drug that may cause birth defects. Male subjects must also agree to either avoid intercourse or that they and/or any female partners of reproductive/childbearing potential will use a highly effective form of contraception during and upon completion of the study and for at least 4.5 mo after the last dose of trastuzumab deruxtecan.
9. Non-childbearing potential is defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 mo of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use 1 of the contraception methods for women of childbearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrolment. For most forms of HRT, at least 2 to 4 wk will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their postmenopausal status, they can resume use of HRT during the study without use of a contraceptive method.
10. Male subjects must not freeze or donate sperm throughout the study period beginning at Cycle 1 Day 1 and for at least 4.5 mo after the last dose of trastuzumab deruxtecan or Preservation of sperm should be considered prior to enrollment in this study.
11. Female subjects must not donate ova or retrieve them for their own use from the time of Screening and throughout the study treatment period, and for at least 7 mo after the last dose of trastuzumab deruxtecan. 
 
ExclusionCriteria 
Details  1. Prior treatment with T-DXd
2. Uncontrolled or significant cardiovascular disease, including any of the following:
a. History of myocardial infarction within 6 months before enrolment
b. History of symptomatic congestive heart failure (New York Heart Association Class II to IV);
c. Corrected QT interval (QTc) prolongation to less than 470 ms (females) or less than 450 ms (male);
d. LVEF more than 50% within 28 d prior to treatment initiation.
3. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
4. Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
− Subjects with clinically inactive brain metastases may be included in the study.
− Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 wk must have elapsed between the end of whole brain radiotherapy and study enrollment.
5. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product or to other mAbs.
6. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
7. Known human immunodeficiency virus (HIV) infection or active hepatitis B or C infection.
8. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade less than or equal to 1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the investigator after consultation with the Sponsor Medical Monitor or designee (eg, Grade 2 chemotherapy-induced neuropathy).
9. Therapeutic radiation therapy or major surgery within 4 wk before enrolment or palliative stereotactic radiation therapy within 2 wk before enrolment.
10. Systemic treatment with anticancer therapy (immunotherapy [non-antibody-based therapy], retinoid therapy, or hormonal therapy) within 3 wk before enrolment; antibody-based-anticancer-therapy within 4 wk before enrolment; or treatment with nitrosoureas or mitomycin C within 6 wk before randomization; or treatment with small-molecule targeted agents within 2 wk or 5 half-lives before enrolment, whichever is longer.
11. Participation in a therapeutic clinical study within 3 wk before enrolment (for small-molecule targeted agents, this non-participation period is 2 wk or 5 half-lives, whichever is longer), or current participation in other investigational procedures.
12. Pregnant, breastfeeding, or planning to become pregnant.
13. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion etc), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjögren’s, sarcoidosis etc), or prior pneumonectomy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the safety of trastuzumab deruxtecan in adult Indian patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.  40 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of Adverse Events  40 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 4 
Date of First Enrollment (India)   02/01/2025 
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="6"
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  
Breast cancer is the most diagnosed and deadliest cancer among women worldwide. In 2020, it has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases. According to the GLOBOCAN 2020 data, in India alone, there were 1.78 lakh new cases and 90,408 deaths.
In approximately 20% of breast cancer cases, overexpression of human epidermal growth factor receptor 2 (HER2) occurs. Compared to HER2-negative breast cancer, HER2-positive breast cancers have historically been associated with more aggressive disease and worse outcomes.
Trastuzumab deruxtecan (T-DXd) is a novel human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) composed of a humanized anti-HER2 immunoglobulin G1 (IgG1) monoclonal antibody with the same amino acid sequence as trastuzumab, covalently linked to a topoisomerase I inhibitor, an exatecan derivative, via a tetrapeptide-based cleavable linker. Deruxtecan is composed of the linker and the topoisomerase I inhibitor
This phase-IV study is planned with an aim to assess the safety of Trastuzumab deruxtecan in Indian subjects receiving the drug as per the approved label indications in India in accordance with the requirements of the Health Authorities of India. The data obtained from the present study will help to understand the safety profile of Trastuzumab deruxtecan among Indian patients
 
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