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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06103864




Registration number
NCT06103864
Ethics application status
Date submitted
23/10/2023
Date registered
27/10/2023

Titles & IDs
Public title
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
Scientific title
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
Secondary ID [1] 0 0
D7630C00001
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 - Paclitaxel
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pembrolizumab

Experimental: Dato-DXd + durvalumab - Arm 1: Dato-DXd + durvalumab

Active comparator: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab - Arm 2: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin)

Experimental: Dato-DXd - Arm 3: Dato-DXd


Treatment: Drugs: Dato-DXd
Provided in 100mg vials. IV infusion. Experimental drug.

Treatment: Drugs: Durvalumab
Provided in 500mg vials. IV infusion. Experimental drug.

Treatment: Drugs: Paclitaxel
IV infusion. Active comparator.

Treatment: Drugs: Nab-paclitaxel
IV infusion. Active comparator.

Treatment: Drugs: Gemcitabine
IV infusion. Active comparator.

Treatment: Drugs: Carboplatin
IV infusion. Active comparator.

Treatment: Drugs: Pembrolizumab
IV infusion. Active comparator.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (anticipated to be up to 33 months).
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomisation until the date of death due to any cause (anticipated to be up to 64 months).
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
From randomisation up until progression (anticipated to be up to 33 months).
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
From the date of first documented response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause (anticipated to be up to 33 months).
Secondary outcome [4] 0 0
Progression-Free Survival (PFS) by Investigator assessment
Timepoint [4] 0 0
From randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause (anticipated to be up to 33 months).
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR) at 24 weeks
Timepoint [5] 0 0
From randomisation up until progression, or the last evaluable assessment in the absence of progression (anticipated to be up to 33 months).
Secondary outcome [6] 0 0
Time to deterioration (TTD) in breast and arm symptoms in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
Timepoint [6] 0 0
From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Secondary outcome [7] 0 0
Time to deterioration (TTD) in pain in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
Timepoint [7] 0 0
Time from the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Secondary outcome [8] 0 0
Time to deterioration (TTD) in physical functioning in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
Timepoint [8] 0 0
From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Secondary outcome [9] 0 0
Time to deterioration (TTD) in GHS/QoL in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
Timepoint [9] 0 0
From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Secondary outcome [10] 0 0
Time to First Subsequent Therapy (TFST)
Timepoint [10] 0 0
From randomisation until the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause (anticipated to be up to 64 months).
Secondary outcome [11] 0 0
Time to Second Subsequent Therapy (TSST)
Timepoint [11] 0 0
From randomisation until the start date of the second subsequent anti cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (anticipated to be up to 64 months).
Secondary outcome [12] 0 0
Progression Free Survival 2 (PFS2)
Timepoint [12] 0 0
From the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death (anticipated to be up to 64 months).
Secondary outcome [13] 0 0
Pharmacokinetics of Dato-DXd in combination with durvalumab
Timepoint [13] 0 0
From first dose to end of treatment (anticipated to be up to 33 months).
Secondary outcome [14] 0 0
Immunogenicity of Dato-DXd in combination with durvalumab
Timepoint [14] 0 0
From first dose to end of treatment safety follow-up (anticipated to be up to 33 months).
Secondary outcome [15] 0 0
Safety and tolerability of Dato-DXd + durvalumab as compared with ICC + pembrolizumab
Timepoint [15] 0 0
From first dose to end of treatment safety follow-up (anticipated to be up to 33 months).

Eligibility
Key inclusion criteria
Key Inclusion Criteria

* Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines.
* ECOG PS 0 or 1.
* All participants must provide a FFPE metastatic or locally recurrent inoperable tumour sample.
* PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS = 10) from a sponsor designated central laboratory.
* No prior chemotherapy or targeted systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.

- Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and =6 months have elapsed between completion of treatment with curative intent and the first documented recurrence.
* Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin).
* Measurable disease as per RECIST 1.1.
* Adequate bone marrow reserve and organ function.
* Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* As judged by investigator, severe or uncontrolled medical conditions including systemic diseases, history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection, significant cardiac or psychological conditions.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before Cycle 1 Day 1 and of low potential risk for recurrence.
* Neoplastic spinal cord compression or active brain metastases, leptomeningeal carcinomatosis or history of leptomeningeal carcinomatosis.

- Participants with treated clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.
* Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.
* Active or uncontrolled hepatitis B or C virus infection.
* Known HIV infection that is not well controlled.
* Uncontrolled or significant cardiac disease.
* History of non-infectious ILD/pneumonitis (including radiation pneumonitis) that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Severe pulmonary function compromise.
* Clinically significant corneal disease.
* Active or prior documented autoimmune or inflammatory disorders.
* Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy.
* Any concurrent anti-cancer treatment.
* Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors or Dato-DXd.
* Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

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
23/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/04/2029
Actual
Sample size
Target
625
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Darlinghurst
Recruitment hospital [3] 0 0
Research Site - Heidelberg
Recruitment hospital [4] 0 0
Research Site - Melbourne
Recruitment hospital [5] 0 0
Research Site - Nedlands
Recruitment hospital [6] 0 0
Research Site - Waratah
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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Wisconsin
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Argentina
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Caba
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Argentina
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Ciudad Autonoma Bs As
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Argentina
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Rosario
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Düsseldorf
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Essen
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Georgsmarienhütte
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Hamburg
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Hannover
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Germany
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Heidelberg
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Germany
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Heilbronn
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Germany
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Leipzig
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India
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Calicut
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India
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Kochi
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India
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Kolkata
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India
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India
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Mohali
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India
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Nagpur
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India
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Nashik
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India
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Pondicherry
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India
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Surat
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India
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India
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Vishakapatnam
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Empoli
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Italy
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Milan
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Italy
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Modena
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Italy
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Napoli
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Padova
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Rozzano
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Chiba-shi
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Chuo-ku
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Osakasayama-shi
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Shinagawa-ku
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Shinjuku-ku
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Tsu-shi
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Tsukuba
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Busan
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Daegu
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Seoul
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CD Mexico
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Mexico City
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Tuxtla Gutierrez
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Bacolod
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Gdansk
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Gdynia
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Konin
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Kraków
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Legnica
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Wroclaw
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Lódz
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Singapore
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Hospitalet deLlobregat
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Madrid
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Country [182] 0 0
Thailand
State/province [182] 0 0
Bangkok
Country [183] 0 0
Thailand
State/province [183] 0 0
Chiang Mai
Country [184] 0 0
Thailand
State/province [184] 0 0
Dusit
Country [185] 0 0
Thailand
State/province [185] 0 0
Khon Kaen
Country [186] 0 0
Thailand
State/province [186] 0 0
Songkhla
Country [187] 0 0
Turkey
State/province [187] 0 0
Ankara
Country [188] 0 0
Turkey
State/province [188] 0 0
Besevler Ankara
Country [189] 0 0
Turkey
State/province [189] 0 0
Izmir
Country [190] 0 0
Turkey
State/province [190] 0 0
Küçükçekmece
Country [191] 0 0
Turkey
State/province [191] 0 0
Samsun
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Cardiff
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Chelsea
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Leicester
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Liverpool
Country [196] 0 0
United Kingdom
State/province [196] 0 0
London
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Oxford
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Surrey
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Sutton
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Taunton
Country [201] 0 0
Vietnam
State/province [201] 0 0
Hanoi
Country [202] 0 0
Vietnam
State/province [202] 0 0
Ho Chi Minh City
Country [203] 0 0
Vietnam
State/province [203] 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
[email protected]
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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

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/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT06103864