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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06112379




Registration number
NCT06112379
Ethics application status
Date submitted
12/10/2023
Date registered
1/11/2023

Titles & IDs
Public title
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
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 Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
Secondary ID [1] 0 0
2023-505928-59-00
Secondary ID [2] 0 0
D926QC00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dato-DXd
Treatment: Drugs - Durvalumab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Epirubicin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Capecitabine
Treatment: Drugs - Olaparib

Experimental: Dato-DXd plus durvalumab - Participants receive durvalumab every 3 weeks (Q3W) + Dato-DXd Q3W as neoadjuvant therapy prior to surgery; followed by 9 cycles of durvaluamb Q3W as adjuvant therapy post-surgery. 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

Adjuvant chemotherapy may be one of these:

1. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) and carboplatin (weekly or Q3W) for 4 cycles (12 weeks);
2. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) for 4 cycles (12 weeks);
3. Carboplatin (weekly or Q3W) + paclitaxel (weekly) for 4 cycles (12 weeks);
4. Capecitabine (Q3W) for 8 cycles.

Active comparator: Pembrolizumab plus chemotherapy - Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Adjuvant capecitabine (Q3W) for 8 cycles 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.


Treatment: Drugs: Dato-DXd
Experimental drug IV infusion

Treatment: Drugs: Durvalumab
Experimental drug IV Infusion

Treatment: Drugs: Pembrolizumab
IV Infusion Active comparator

Treatment: Drugs: Doxorubicin
IV infusion Experimental/Active Comparator

Treatment: Drugs: Epirubicin
IV Infusion Experimental/Active Comparator

Treatment: Drugs: Cyclophosphamide
IV infusion Experimental/Active Comparator

Treatment: Drugs: Paclitaxel
IV infusion Experimental/Active Comparator

Treatment: Drugs: Carboplatin
IV infusion Experimental/Active Comparator

Treatment: Drugs: Capecitabine
Tablet Oral route of administration Experimental/Active Comparator

Treatment: Drugs: Olaparib
Tablet Oral route of administration Experimental/Active Comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathologic Complete Response (pCR) in the experimental vs control arms
Timepoint [1] 0 0
At the time of definitive surgery
Primary outcome [2] 0 0
Event-free survival (EFS) in the experimental vs control arms
Timepoint [2] 0 0
Date of randomization to date of the EFS event, up to 68 months after the first subject randomized
Secondary outcome [1] 0 0
Overall Survival (OS) in the experimental vs control arms
Timepoint [1] 0 0
Date of randomization to date of death due to any cause, up to 82 months after the first subject randomized
Secondary outcome [2] 0 0
Distant disease-free survival (DDFS) in the experimental vs control arms
Timepoint [2] 0 0
Date of randomization to date of the DDFS event, up to 68 months after the first subject randomized
Secondary outcome [3] 0 0
Participant-reported breast and arm symptoms in the experimental vs. control arms
Timepoint [3] 0 0
From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first.
Secondary outcome [4] 0 0
Participant-reported physical function in the experimental vs. control arms
Timepoint [4] 0 0
From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks).
Secondary outcome [5] 0 0
Participant-reported fatigue in the experimental vs. control arms
Timepoint [5] 0 0
From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks).
Secondary outcome [6] 0 0
Participant-reported Global health status/Quality of life (GHS/QoL)in the experimental vs. control arms
Timepoint [6] 0 0
From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks).
Secondary outcome [7] 0 0
Pharmacokinetics of Dato-DXd (in combination with durvalumab)
Timepoint [7] 0 0
Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
Secondary outcome [8] 0 0
Pharmacokinetics of Dato-DXd (in combination with durvalumab)
Timepoint [8] 0 0
Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
Secondary outcome [9] 0 0
Pharmacokinetics of Dato-DXd (in combination with durvalumab)
Timepoint [9] 0 0
Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
Secondary outcome [10] 0 0
Immunogenicity of Dato-DXd (in combination with durvalumab)
Timepoint [10] 0 0
Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
Secondary outcome [11] 0 0
Safety of Dato-DXd (in combination with durvalumab)
Timepoint [11] 0 0
Randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely

Eligibility
Key inclusion criteria
* Participant must be = 18 years, at the time of signing the ICF.
* Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
* ECOG PS of 0 or 1
* Provision of acceptable tumor sample
* Adequate bone marrow reserve and organ function
* Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and aligned with protocol requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* History of any prior invasive breast malignancy
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 5 years before randomization.
* active or prior documented autoimmune or inflammatory disorders.
* Evidence of distant disease.
* Clinically significant corneal disease.
* Has active or uncontrolled hepatitis B or C virus infection.
* Known HIV infection that is not well controlled.
* Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
* Known to have active tuberculosis infection
* Mean resting corrected QTcF interval > 470 ms obtained from ECG
* Uncontrolled or significant cardiac disease.
* History of non-infectious ILD/pneumonitis
* Has severe pulmonary function compromise
* Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
* For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.
* Concurrent use of systemic hormone replacement therapy or oral hormonal contraception

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/08/2030
Actual
Sample size
Target
1728
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - East Melbourne
Recruitment hospital [3] 0 0
Research Site - Heidelberg
Recruitment hospital [4] 0 0
Research Site - Herston
Recruitment hospital [5] 0 0
Research Site - Nedlands
Recruitment hospital [6] 0 0
Research Site - Waratah
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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Japan
State/province [181] 0 0
Osaka-shi
Country [182] 0 0
Japan
State/province [182] 0 0
Sapporo-shi
Country [183] 0 0
Japan
State/province [183] 0 0
Sendai-shi
Country [184] 0 0
Japan
State/province [184] 0 0
Shinagawa-ku
Country [185] 0 0
Japan
State/province [185] 0 0
Shinjuku-ku
Country [186] 0 0
Japan
State/province [186] 0 0
Sunto-gun
Country [187] 0 0
Japan
State/province [187] 0 0
Tokyo
Country [188] 0 0
Japan
State/province [188] 0 0
Tsu-shi
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Japan
State/province [189] 0 0
Yokohama-shi
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Korea, Republic of
State/province [190] 0 0
Daegu
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Korea, Republic of
State/province [191] 0 0
Goyang-si
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Korea, Republic of
State/province [192] 0 0
Seongnam
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Korea, Republic of
State/province [193] 0 0
Seoul
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Malaysia
State/province [194] 0 0
George Town
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Malaysia
State/province [195] 0 0
Kuala Lumpur
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Malaysia
State/province [196] 0 0
Kuching
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Malaysia
State/province [197] 0 0
Selangor
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Poland
State/province [198] 0 0
Bialystok
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Poland
State/province [199] 0 0
Bydgoszcz
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Poland
State/province [200] 0 0
Gdansk
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Poland
State/province [201] 0 0
Gdynia
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Poland
State/province [202] 0 0
Tomaszów Mazowiecki
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Poland
State/province [203] 0 0
Warszawa
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Poland
State/province [204] 0 0
Wroclaw
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Poland
State/province [205] 0 0
Lódz
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State/province [206] 0 0
Singapore
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Spain
State/province [207] 0 0
Barcelona
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Spain
State/province [208] 0 0
Granada
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Spain
State/province [209] 0 0
Hospitalet deLlobregat
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Spain
State/province [210] 0 0
Madrid
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Spain
State/province [211] 0 0
Santiago de Compostela
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Spain
State/province [212] 0 0
Sevilla
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Spain
State/province [213] 0 0
Zaragoza
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State/province [214] 0 0
Baden
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Switzerland
State/province [215] 0 0
Basel
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Switzerland
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Bern
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Switzerland
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Frauenfeld
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Switzerland
State/province [218] 0 0
Rennaz
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State/province [219] 0 0
Changhua
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Taiwan
State/province [220] 0 0
Kaohsiung
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Taiwan
State/province [221] 0 0
Taichung
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Taiwan
State/province [222] 0 0
Tainan
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Taiwan
State/province [223] 0 0
Taipei
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Taiwan
State/province [224] 0 0
Taoyuan
Country [225] 0 0
Thailand
State/province [225] 0 0
Bangkok
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Thailand
State/province [226] 0 0
Dusit
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Thailand
State/province [227] 0 0
Muang
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Thailand
State/province [228] 0 0
Songkhla
Country [229] 0 0
Turkey
State/province [229] 0 0
Adapazari
Country [230] 0 0
Turkey
State/province [230] 0 0
Ankara
Country [231] 0 0
Turkey
State/province [231] 0 0
Istanbul
Country [232] 0 0
Turkey
State/province [232] 0 0
Kayseri
Country [233] 0 0
Turkey
State/province [233] 0 0
Samsun
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United Kingdom
State/province [234] 0 0
Birmingham
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Cardiff
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United Kingdom
State/province [236] 0 0
Edinburgh
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United Kingdom
State/province [237] 0 0
Guildford
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United Kingdom
State/province [238] 0 0
Lancaster
Country [239] 0 0
United Kingdom
State/province [239] 0 0
London
Country [240] 0 0
United Kingdom
State/province [240] 0 0
Northampton
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Oxford
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Taunton
Country [243] 0 0
Vietnam
State/province [243] 0 0
Hanoi
Country [244] 0 0
Vietnam
State/province [244] 0 0
Ho Chi Minh city
Country [245] 0 0
Vietnam
State/province [245] 0 0
Vinh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06112379