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CTRI Number  CTRI/2024/04/065322 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Phase III Randomised Study to Evaluate Dato DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor low/HER2-negative Breast Cancer 
Scientific Title of Study   A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Untreated Triple Negative or Hormone Receptor low/HER2-negative Breast Cancer (D926QC00001; TROPION Breast04) 
Trial Acronym  TROPION Breast-04 
Secondary IDs if Any  
Secondary ID  Identifier 
2023-505928-59-00  EudraCT 
D926QC00001 V1.0 Dated 17 Aug 2023  Protocol Number 
Local CSP - Addendum IND-1: Version 1.0 Dated 25 Aug 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandeep AV 
Designation  Senior Director, Oncology Country Head – Oncology Site Management & Monitoring India 
Affiliation  AstraZeneca Pharma India Ltd 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road.

Bangalore
KARNATAKA
560045
India 
Phone  9845079472  
Fax  08067748857  
Email  Sandeep.AV@astrazeneca.com  
 
Details of Contact Person
Scientific Query  
Name  Sandeep AV 
Designation  Senior Director, Oncology Country Head – Oncology Site Management & Monitoring India 
Affiliation  AstraZeneca Pharma India Ltd 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road.


KARNATAKA
560045
India 
Phone  9845079472  
Fax  08067748857  
Email  Sandeep.AV@astrazeneca.com  
 
Details of Contact Person
Public Query  
Name  Sandeep AV 
Designation  Senior Director, Oncology Country Head – Oncology Site Management & Monitoring India 
Affiliation  AstraZeneca Pharma India Ltd 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road.


KARNATAKA
560045
India 
Phone  9845079472  
Fax  08067748857  
Email  Sandeep.AV@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca AB 151 85 Sodertalje, Sweden 
 
Primary Sponsor  
Name  AstraZeneca AB 
Address  151 85 Södertälje Sweden a member of the AstraZeneca group (Company) 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
AstraZeneca Pharma India Ltd  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road, Bangalore – 560045, India  
 
Countries of Recruitment     Australia
Austria
Belgium
Brazil
Bulgaria
Canada
China
France
Germany
Hong Kong
Hungary
India
Italy
Japan
Malaysia
Poland
Republic of Korea
Singapore
Spain
Switzerland
Taiwan
Thailand
Turkey
United Kingdom
United States of America
Viet Nam  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Gupta  Bhagwan Mahavir Cancer Research Center  Dept. of Medical Oncology Bhagwan Mahavir Cancer Research Center Jawahar Lal Nehru Marg, Jaipur 302017, India
Jaipur
RAJASTHAN 		 9001795275

drdeepakgupta@yahoo.co.in 
Dr Mukesh Chaudhari  HCG Manavata cancer centre  Dept. of Medical Oncology HCG Manavata cancer centre, Behind shivang Auto, Mumbai Naka, Nashik 422002, Maharastra, India
Nashik
MAHARASHTRA 		 9096920416

drmukesh@mcrinasik.com 
Dr Ankit Batra  Himalayan institute of medical sciences  Dept. of Medical Oncology Himalayan institute of medical sciences, Swami Rama Himalayan University Swami Ram Nagar, Beside Jolly Grant Airport Jolly Grant, Doiwala, Uttarakhand 248016
Dehradun
UTTARANCHAL 		 9411712969

drankitbatra@gmail.com 
Dr Biswait Dubhashi  Jawaharlal Institute of Postgraduate Medical Education and Research  Dept. of Medical Oncology Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY 		 8056338405

drbiswajitdm@gmail.com 
Dr Niraj Bhatt  Kailash Cancer Hospital and Research centre  Dept. of Medical Oncology Kailash Cancer Hospital and Research centre, Muni Seva Ashram Goraj, Waghodia, Gujarat 391760
Vadodara
GUJARAT 		 9925581480

niraj.bhatt@greenashram.org 
Dr Sameer Shrirangwar  KIMS-Kingsway Hospital  Dept. of Medical Oncology KIMS-Kingsway Hospital, 44, Kingsway, Near Kasturchand Park, Nagpur-440001, Maharastra, India
Nagpur
MAHARASHTRA 		 9833633299

dr.sameet.mdmed@gmai.com 
Dr RL Jena  Netai Shubhash Chandra Bose Cancer Hospital  Dept. of Medical Oncology Netai Shubhash Chandra Bose Cancer Hospital 3081 Nayabad, New Garia, Kolkata 700094, West Bengal, India
Kolkata
WEST BENGAL 		 8617775659

rajivjena1986@gmail.com 
Dr Chandrakanth MV  NH-Rabindranath Tagore International Institute of Cardiac Sciences  Dept. of Medical Oncology NH-Rabindranath Tagore International Institute of Cardiac Sciences. Premised No 1489 (124), Mukundapur, E M Bypass,.PIN -700099. West Bengal
Kolkata
WEST BENGAL 		 7003206633

drmvch@gmail.com 
Dr Lokesh KN  Radhakrishna Multispeciality Hospital & IVF Cente  Dept. of Medical Oncology Radhakrishna Multispeciality Hospital & IVF Center Radhakrishna Multispeciality Hospital, 3-4 Sunrise Towers, 3-4, JP Rd, opp. CANARA Bank, 1st phase Girinagar, Banashankari 3rd Stage, Bengaluru, Karnataka 560085
Bangalore
KARNATAKA 		 8971609070

knloki@gmail.com 
Dr Dinesh Chandra Doval  Rajiv Gandhi Cancer Institute and Research Centre  Dept. of Medical Oncology Rajiv Gandhi Cancer Institute and Research Centre, Sir Chotu Ram Marg, Sector – 5, Rohini, New Delhi - 110085
New Delhi
DELHI 		 9810836274

dcdoval@gmail.com 
Dr Rona Joseph  Regional Cancer Centre, Medical College Campus  Dept. of Medical Oncology Regional Cancer Centre, Medical College Campus Kumarapuram Rd, Medical College Campus, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA 		 8281468929

ronsjsph@gmail.com 
Dr Kaushal Kalra  VMMC and Safdarjung Hospital  Dept. of Medical Oncology VMMC and Safdarjung Hospital Main OPD Building, 3rd Floor, Room No-313, VMMC and Safdarjung Hospital, Ansari Nagar East, near to AIIMS Metro Station, New Delhi 110029
New Delhi
DELHI 		 9968663394

kaushalkalra@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethics Committee NSCBC Research Institute. Netaji Subhas Chandra Bose Cancer Hospital  Approved 
Insitutional Ethics Committee VMMC & Safdarjung Hopsital  Approved 
Institutional Ethics committee Department of Community Medicine, BGS Health and Education City  Approved 
Institutional Ethics Committee Bhagwan Mahaveer Cancer Hospital & Research centre  Approved 
Institutional Ethics committee Swami Rama Himalayan University  Submittted/Under Review 
Institutional Ethics committee, JIPMER  Submittted/Under Review 
Institutional Ethics committee-KCHRC Kailash Cancer and Medica  Approved 
Institutional Ethics committee. Regional Cancer Centre, Medical College Campus  Approved 
Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre  Approved 
Kingsway Hospital Ethics Committee  Approved 
Manavata Clinical Research Institute Ethic Committee, HCG Manavata Cancer Centre  Approved 
NHRTIICS Ethics committee Rabindranath Tagore International Institute of Cardiac Sciences  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  Control arm: Pembrolizumab plus chemotherapy neoadjuvant therapy followed by pembrolizumab-based adjuvant therapy:    Neoadjuvant setting (prior to surgery): o Pembrolizumab (200 mg i.v. Q3W) + carboplatin (AUC 5 mg/mL/minute i.v. Q3W; or AUC 1.5 mg/mL/minute i.v. weekly [based on investigator preference]) + paclitaxel (80 mg/m2 i.v. weekly) for 4 cycles (12 weeks), then: o Pembrolizumab (200 mg i.v. Q3W) + cyclophosphamide (600 mg/m2 i.v. Q3W) + either doxorubicin (60 mg/m2 i.v. Q3W) or epirubicin (90 mg/m2 i.v. Q3W) for 4 cycles (12 weeks).  Adjuvant setting (following surgery): pembrolizumab (200 mg i.v. Q3W) for 9 cycles (27 weeks). Adjuvant capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles (24 weeks; choice between the 2 doses will be determined by standard institutional practice) may be given in combination with pembrolizumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease (300 mg orally BID for 1 year) but participants cannot receive capecitabine and olaparib concurrently.  
Intervention  Experimental Arm: Dato DXd plus durvalumab neoadjuvant therapy followed by durvalumab-based adjuvant therapy   Experimental arm: Dato-DXd plus durvalumab neoadjuvant therapy followed by durvalumab-based adjuvant therapy:  Neoadjuvant setting (prior to surgery): Dato-DXd (6 mg/kg i.v. Q3W) + durvalumab (1120 mg i.v. Q3W) for 8 cycles (24 weeks).  Adjuvant setting (following surgery): Durvalumab (1120 mg i.v. Q3W for 9 cycles). Adjuvant chemotherapy may be given in combination with durvalumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease (300 mg orally BID for 1 year) but participants cannot receive chemotherapy and olaparib concurrently. Chemotherapy may be: o Either doxorubicin (60 mg/m2 i.v. Q3W) or epirubicin (90 mg/m2 i.v. Q3W) + cyclophosphamide (600 mg/m2 i.v. Q3W) for 4 cycles (12 weeks) followed by paclitaxel (80 mg/m2 i.v. weekly) and carboplatin (AUC 5 mg/mL/minute i.v. Q3W; or AUC 1.5 mg/mL/minute i.v. weekly [based on investigator preference]) for 4 cycles (12 weeks); o Either doxorubicin (60 mg/m2 i.v. Q3W) or epirubicin (90 mg/m2 i.v. Q3W) + cyclophosphamide (600 mg/m2 i.v. Q3W) for 4 cycles (12 weeks) followed by paclitaxel (80 mg/m2 i.v. weekly) for 4 cycles (12 weeks); o Carboplatin (AUC 5 mg/mL/minute i.v. Q3W; or AUC 1.5 mg/mL/minute i.v. weekly [based on investigator preference]) + paclitaxel (80 mg/m2 i.v. weekly) for 4 cycles (12 weeks); o Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles (24 weeks; choice between the 2 doses will be determined by standard institutional practice) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Inclusion criteria
Informed consent
Age
1. Participant must be 18 years, at the time of signing the ICF.
Type of Participant and Disease Characteristics
1. Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer defined as the following combined primary tumour T and regional lymph node N staging per AJCC for breast cancer staging system edition 8 as assessed by the investigator based on radiological and/or clinical assessment.
1. Negative for ER with 1 of tumour cells positive for ER on IHC and negative for PR with of tumour cells positive for PR on IHC, or hormone receptor-low and
TNBC or hormone receptor-low/HER2-negative breast cancer is defined as:
1. Negative for HER2 with 0 or 1 intensity on IHC, or 2 intensity on IHC and no evidence of amplification on ISH.
2. ECOG PS of 0 or 1.
3. Provision of acceptable tumour sample prior to randomisation as defined in the Laboratory Manual.
Note: Sample collected in China will comply with local regulatory approval.
1. Adequate bone marrow reserve and organ function within 7 days before randomisation, Sex and Contraceptive/Barrier Requirements
2. Male and/or female
Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Informed Consent
1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this CSP.
2. Provision of signed and dated written optional genetic research information informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative.
Other Inclusion Criteria
1. All races, gender and ethnic groups are eligible for this study.
 
 
ExclusionCriteria 
Details  Exclusion criteria
Medical conditions
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. As judged by the investigator, any evidence of diseases such as severe or uncontrolled systemic diseases, which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
2. Refractory nausea and vomiting, inability to swallow a formulated product, or previous significant bowel resection, that would preclude adequate absorption, distribution, metabolism, or excretion of capecitabine or olaparib.
3. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence.
4. Active or prior documented autoimmune or inflammatory disorders
5. Evidence of distant disease.
6. Clinically significant corneal disease.
7. Has active or uncontrolled hepatitis B or C virus infection.
7a. Are HBsAg-positive with chronic HBV infection
1. Known HIV infection that is not well controlled.
2. Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections.
3. Known to have active tuberculosis infection
4. Resting ECG with clinically significant abnormal findings.
5. Uncontrolled or significant cardiac disease
6. History of non-infectious ILD pneumonitis including radiation pneumonitis that required steroids, has current ILD pneumonitis, or has suspected ILD pneumonitis that cannot be ruled out by imaging at screening.
7. Has severe pulmonary function compromise.
Prior/Concomitant Therapy
1. Any concomitant medication known to be associated with torsades de pointes.
2. Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer.
3. Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period of 14 days before randomisation.
4. Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention.
5. Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To demonstrate superiority of neoadjuvant Dato DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low HER2-negative breast cancer, by central assessment of pCR.

 		 To demonstrate superiority of neoadjuvant Dato DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low HER2-negative breast cancer, by central assessment of pCR.

Baseline and 6 Months ( Post surgery) and 18 Months (Completion of adjuvant treatment)
 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate superiority of neoadjuvant Dato DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer, by assessment of OS.  OS is defined as the time from the date of randomisation until the date of death due to any cause.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest will be the HR of OS.
 
To assess effectiveness of neoadjuvant Dato DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low HER2-negative breast cancer, by assessment of DDFS.  DDFS is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: distant metastasis, occurrence of second primary non-breast invasive cancer other than squamous or basal cell skin cancer, or death by any cause (in the absence of recurrence. DDFS will be determined by the investigator based on all available clinical assessments. 
To assess participant-reported breast and arm symptoms in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer treated with neoadjuvant Dato DXd plus durvalumab relative to neoadjuvant pembrolizumab plus chemotherapy.  Actual scores at Weeks 12 and 24 of the neoadjuvant period in breast and arm symptoms as measured by the EORTC IL116.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest is the mean between-arm difference in breast and arm symptom scores.
 
To assess participant reported physical function in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer treated with neoadjuvant Dato DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy.  Actual scores at Weeks 12 and 24 of the neoadjuvant period, and Weeks 12, 27, and Year 1 of the adjuvant period in physical function as measured by the PROMIS Physical Function Short Form 8c.
The analysis will include all dosed participants.
The measure of interest is the mean between-arm difference in physical function scores.
 
To assess participant reported fatigue in participants with previously untreated TNBC or hormone receptor low/HER2-negative breast cancer treated with neoadjuvant Dato DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy.  Proportion of participants experiencing different levels of fatigue and actual scores at 12 and 24 weeks during the neoadjuvant phase and at 12 and 27 weeks during the adjuvant phase as measured by the PROMIS Fatigue Short Form 7a.
The analysis will include all dosed participants.
 
To assess participant-reported GHS/QoL in participants with previously untreated TNBC or hormone receptor low/HER2-negative breast cancer treated with neoadjuvant Dato DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy.  Actual scores at Weeks 12 and 24 of the neoadjuvant period, and Weeks 12, 27, and Year 1 of the adjuvant period in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest is the mean between-arm difference in GHS/QoL scores.
 
To assess the PK of Dato DXd, total anti TROP2 antibody and DXd (in combination with durvalumab).  Plasma concentrations of Dato-DXd, total anti-TROP2 antibody, and DXd. 
To investigate the immunogenicity of Dato DXd (in combination with durvalumab).  Presence of ADAs for Dato-DXd (confirmatory results: positive or negative, titres). 
To assess the safety and tolerability of neoadjuvant Dato DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.  Safety and tolerability will be evaluated in terms of AEs graded by CTCAE version 5.0) and in assessments including:
• ECOG PS
• Vital signs, body weight, physical examination
• Clinical chemistry and haematology
• Ophthalmologic assessments
ECG
 
 
Target Sample Size   Total Sample Size="1728"
Sample Size from India="75" 
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)   15/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
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  

Brief Summary
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.
Study details include:
• The study duration will be up to 82 months after the first participant has been randomised.
• The treatment duration will be approximately 57 weeks (24 weeks of treatment in the neoadjuvant setting followed by surgery 25 days to 6 weeks after conclusion of neoadjuvant treatment or following early discontinuation, then 27 weeks of treatment in the adjuvant setting). Treatment duration will be longer for participants receiving up to 1 year of adjuvant olaparib treatment. Adjuvant radiotherapy may be given concurrently with adjuvant durvalumab or pembrolizumab monotherapy but not concurrently with adjuvant chemotherapy. Adjuvant endocrine therapy for hormone receptor-low tumours is permitted per investigator’s discretion (Note: participants cannot receive adjuvant CDK4/6 inhibitor therapy, including abemaciclib and ribociclib). All participants will receive study intervention in the neoadjuvant and adjuvant setting. Note, endocrine therapy is not considered study intervention and as such will not be provided by AstraZeneca.
• The on-treatment visit frequency will be weekly to Q3W.

 
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