Metastatic Breast CancerPhase 1/2DB-07NCT04538742
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
A Phase 1/2 study testing Trastuzumab deruxtecan, Durvalumab and Paclitaxel in people with Metastatic Breast Cancer, run by AstraZeneca at 72 sites in 15 countries.
Trial summary
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Trastuzumab deruxtecan, Durvalumab and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 72 sitesin 15 countries
- Study dates
- 28 Dec 2020to 31 Jan 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be at least 18 years of age
- Pathologically documented breast cancer that:
- Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic
- HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment. The local HER2 result must be from a tumour sample obtained in the metastatic setting.
- Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
- Patient must have adequate tumor sample from the metastatic setting for biomarker assessment
Show all 16Show fewer
- ECOG Performance Status of 0 or 1
- Part 1
- Disease progression on or after the last systemic therapy prior to starting study treatment
- At least 1 prior treatment line in metastatic setting required.
- Part 2 (Modules 0 - 5)
- No prior lines of therapy for advanced/MBC allowed
- Part 2 (Module 6 and 7) a) Zero or one prior lines of therapy for advanced/MBC allowed
- CNS Inclusion
- Modules 0 - 5 Patients must have no brain metastases or stable brain metastases.
- Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy
Who cannot join
- Uncontrolled or significant cardiovascular disease
- Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Lung-specific intercurrent clinically significant illnesses
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Spinal cord compression or a history of leptomeningeal carcinomatosis
- Prior treatment with immune checkpoint inhibitors
Show all 11Show fewer
- Prior treatment with an ADC containing a topoisomerase I inhibitor
- Prior treatment with tucatinib
- CNS Exclusion
- Modules 0 - 5: Has untreated brain metastasis
- Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg dexamethasone or any brain lesion thought to require immediate local therapy
Trial locations and contacts
72 sites in 15 countries.
72 sites in 15 countries
United States10 sites
Research Site
Columbus, Ohio, 43219
Research Site
Commack, New York, 11725
Research Site
Fairfax, Virginia, 22031
Research Site
Fort Myers, Florida, 33901
Research Site
Fort Worth, Texas, 76104
Research Site
Harrison, New York, 10604
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10016
Research Site
New York, New York, 10065
Research Site
St. Petersburg, Florida, 33705
Russia10 sites
Research Site
Moscow, 105229
Research Site
Moscow, 109240
Research Site
Moscow, 111123
Research Site
Moscow, 115478
Research Site
Moscow, 117997
Research Site
Moscow, 121205
Research Site
Moscow, 143423
Research Site
Saint Petersburg, 195271
Research Site
Saint Petersburg, 196603
Research Site
Saint Petersburg, 197758
Brazil9 sites
Research Site
Barretos, 14784-400
Research Site
Belo Horizonte, 30150-274
Research Site
Natal, 59075-740
Research Site
Porto Alegre, 90610-000
Research Site
Porto Alegre, 91350-200
Research Site
Rio de Janeiro, 20560-120
Research Site
São Paulo, 01317-001
Research Site
São Paulo, 04029-000
Research Site
Sorocaba, 18030-005
Taiwan8 sites
Research Site
Hualien City, 970
Research Site
Tainan, 704
Research Site
Taipei, 10048
Research Site
Taipei, 10449
Research Site
Taipei, 11217
Research Site
Taipei, 114
Research Site
Taipei, 235
Research Site
Taoyuan City, 333
South Korea5 sites
Research Site
Busan, 602-739
Research Site
Seoul, 02841
Research Site
Seoul, 03080
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Spain5 sites
Research Site
Barcelona, 08003
Research Site
L'Hospitalet de Llobregat, 08908
Research Site
Madrid, 28007
Research Site
Madrid, 28050
Research Site
Seville, 41013
Turkey (Türkiye)5 sites
Research Site
Ankara, 6100
Research Site
Edirne, 22030
Research Site
Istanbul, 34662
Research Site
Istanbul, 34722
Research Site
Izmir, 35100
India4 sites
Research Site
Delhi, 110085
Research Site
Gūrgaon, 122001
Research Site
Madurai, 625107
Research Site
Mumbai, 400012
Italy4 sites
Research Site
Bologna, 40138
Research Site
Milan, 20141
Research Site
Naples, 80131
Research Site
Rome, 168
Poland4 sites
Research Site
Bydgoszcz, 85-796
Research Site
Koszalin, 75-581
Research Site
Lodz, 90-242
Research Site
Lublin, 20-090
Canada3 sites
Research Site
Montreal, Quebec, H2X 0A9
Research Site
Québec, Quebec, G1S 4L8
Research Site
Toronto, M5G 2M9
About this study
Official title: A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer
Read the detailed description
This study is modular in design allowing assessment of safety, tolerability and anti-tumour activity of T-DXd in combination with other anti-cancer agents. Combination-treatment modules will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the recommended Phase 2 dose (RP2D) determined in Part 1 will be used for the dose-expansion in Part 2.
The target population of interest in this study is patients with HER2-positive (as per ASCO/CAP 2018 guidelines) advanced/MBC inclusive of patients with active and stable brain metastases. Part 1 of each module will enroll patients with locally assessed HER2-positive advanced/MBC in second-line or later patients. Part 2 of each module will enroll patients with locally assessed HER2-positive breast cancer who have not received prior treatment for advanced/metastatic disease.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Trastuzumab deruxtecan, Durvalumab, Paclitaxel, Pertuzumab, Tucatinib
- Keywords
- Breast Cancer, HER2-positive, Brain Metastases, Trastuzumab Deruxtecan, T-DXd, DS-8201a, DESTINY-Breast07, Anti-HER2 Antibody Drug Conjugate (ADC)
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab deruxtecanDrug
Also called DS-8201a, T-DXd
T-DXd: administered as an IV infusion
DurvalumabDrug
Also called MEDI4736
Durvalumab: administered as an IV infusion
PaclitaxelDrug
Paclitaxel: administered as an IV infusion
PertuzumabDrug
Pertuzumab: administered as an IV infusion
TucatinibDrug
Also called ONT-380
Tucatinib administered orally (tablet) twice daily
| Study group | Role | What they receive |
|---|---|---|
| Module 1- T-DXd and Durvalumab | Experimental | T-DXd and Durvalumab Receives: Drug: Trastuzumab deruxtecan; Drug: Durvalumab |
| Module 2- T-DXd and Pertuzumab | Experimental | T-DXd and Pertuzumab Receives: Drug: Trastuzumab deruxtecan; Drug: Pertuzumab |
| Module 3- T-DXd and Paclitaxel | Experimental | T-DXd and Paclitaxel (Arm not initiated in Part 2) Receives: Drug: Trastuzumab deruxtecan; Drug: Paclitaxel |
| Module 4- T-DXd and Durvalumab and Paclitaxel | Experimental | T-DXd and Durvalumab and Paclitaxel (Arm not initiated in Part 1 and Part 2) Receives: Drug: Trastuzumab deruxtecan; Drug: Durvalumab; Drug: Paclitaxel |
| Module 0- T-DXd | Experimental | T-DXd Receives: Drug: Trastuzumab deruxtecan |
| Module 5 - T-DXd and Tucatanib | Experimental | T-DXd and tucatinib (Arm not initiated in Part 2) Receives: Drug: Trastuzumab deruxtecan; Drug: Tucatinib |
| Module 6 - T-DXd and Tucatinib | Experimental | T-DXd and tucatinib in patients with active brain metastases (Part 2 Only) (Arm not initiated) Receives: Drug: Trastuzumab deruxtecan; Drug: Tucatinib |
| Module 7 - T-DXd | Experimental | T-DXd monotherapy in patients with active brain metastases (Part 2 Only) Receives: Drug: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs)- Part 1
Occurrence of AEs in Part 1 graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 53 months
Occurrence of serious adverse events (SAEs)- Part 1
Occurrence of SAEs in Part 1 graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 53 months
Occurrence of adverse events (AEs)- Part 2
Occurrence of AEs in Part 2 graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 53 months
Occurrence of serious adverse events (SAEs)- Part 2
Occurrence of SAEs in Part 2 graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 53 months
Secondary outcomes (13)
Objective Response Rate (ORR)- Part 1 and Part 2
ORR is defined as the proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
Measured: Until progression, assessed up to approximately 53 months
Progression Free Survival (PFS)- Part 1 and Part 2
PFS is defined as time from the date of randomization until the date of progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
Measured: Until progression, assessed up to approximately 53 months
Progression Free Survival 2 (PFS2)- Part 2
PFS2 is defined as time from the date of randomisation until the date of progression on next line treatment (the earliest of the progression event subsequent to first subsequent anticancer therapy) or death; second progression will be defined according to local standard clinical practice.
Measured: Assessed up to approximately 53 months
Duration of Response (DoR)- Part 2
DoR is defined as time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Measured: Until progression, assessed up to approximately 53 months
Overall Survival (OS)- Part 2
OS is defined as time from the date of randomisation until the date of death due to any cause.
Measured: Until death, assessed up to approximately 53 months
Serum Concentration of Trastuzumab Deruxtecan (T-DXd)
Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration
Measured: While on study drug up to study completion, approximately 53 months
Serum Concentration of Durvalumab
Determination of durvalumab concentration in serum at different time points after administration
Measured: While on study drug up to study completion, approximately 53 months
Serum Concentration of Pertuzumab
Determination of pertuzumab concentration in serum at different time points after administration
Measured: While on study drug up to study completion, approximately 53 months
Plasma Concentration of Paclitaxel
Determination of paclitaxel concentration in plasma at different time points after administration
Measured: While on study drug up to study completion, approximately 53 months
Plasma Concentration of Tucatinib
Determination of tucatinib concentration in plasma at different time points after administration
Measured: While on study drug up to study completion, approximately 53 months
Immunogenicity of trastuzumab deruxtecan
Percentage of patients who develop ADA for trastuzumab deruxtecan
Measured: Up to follow-up period, approximately 53 months
Immunogenicity of Durvalumab
Percentage of patients who develop ADA for durvalumab
Measured: Up to follow-up period, approximately 53 months
Immunogenicity of Pertuzumab
Percentage of patients who develop ADA for pertuzumab
Measured: Up to follow-up period, approximately 53 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start28 Dec 2020
- Primary completion31 Jan 2025
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study will consist of 2 phases: a dose escalation phase (Part 1) and a dose expansion phase (Part 2). Part 1 of each module will enroll patients with locally assessed HER2-positive advanced/MBC in second-line or later.Part 2 of each module will enroll patients with locally assessed HER2-positive breast cancer who have not received prior treatment for advanced/metastatic disease.
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Company, Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538742
- Sponsor's protocol ID
- D967JC00001
- Other IDs
- 2023-505309-18-00, 2019-004531-22, 2019, 2023
- Acronym
- DB-07
- Status last verified
- Dec 2025
- First submitted
- 31 Aug 2020
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)
- ClinicalTrials.gov ID
- NCT04538742
- Acronym / sponsor ID
- DB-07 / D967JC00001
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer, HER2-positive, Brain Metastases, Trastuzumab Deruxtecan, T-DXd, DS-8201a, DESTINY-Breast07, Anti-HER2 Antibody Drug Conjugate (ADC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 245 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Company, Limited
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer
Detailed description
This study is modular in design allowing assessment of safety, tolerability and anti-tumour activity of T-DXd in combination with other anti-cancer agents. Combination-treatment modules will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the recommended Phase 2 dose (RP2D) determined in Part 1 will be used for the dose-expansion in Part 2.
The target population of interest in this study is patients with HER2-positive (as per ASCO/CAP 2018 guidelines) advanced/MBC inclusive of patients with active and stable brain metastases. Part 1 of each module will enroll patients with locally assessed HER2-positive advanced/MBC in second-line or later patients. Part 2 of each module will enroll patients with locally assessed HER2-positive breast cancer who have not received prior treatment for advanced/metastatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- The study will consist of 2 phases: a dose escalation phase (Part 1) and a dose expansion phase (Part 2). Part 1 of each module will enroll patients with locally assessed HER2-positive advanced/MBC in second-line or later.Part 2 of each module will enroll patients with locally assessed HER2-positive breast cancer who have not received prior treatment for advanced/metastatic disease.
| Arm | Type | Receives |
|---|---|---|
| Module 1- T-DXd and Durvalumab | Experimental | Drug: Trastuzumab deruxtecan, Drug: DurvalumabT-DXd and Durvalumab |
| Module 2- T-DXd and Pertuzumab | Experimental | Drug: Trastuzumab deruxtecan, Drug: PertuzumabT-DXd and Pertuzumab |
| Module 3- T-DXd and Paclitaxel | Experimental | Drug: Trastuzumab deruxtecan, Drug: PaclitaxelT-DXd and Paclitaxel (Arm not initiated in Part 2) |
| Module 4- T-DXd and Durvalumab and Paclitaxel | Experimental | Drug: Trastuzumab deruxtecan, Drug: Durvalumab, Drug: PaclitaxelT-DXd and Durvalumab and Paclitaxel (Arm not initiated in Part 1 and Part 2) |
| Module 0- T-DXd | Experimental | Drug: Trastuzumab deruxtecanT-DXd |
| Module 5 - T-DXd and Tucatanib | Experimental | Drug: Trastuzumab deruxtecan, Drug: TucatinibT-DXd and tucatinib (Arm not initiated in Part 2) |
| Module 6 - T-DXd and Tucatinib | Experimental | Drug: Trastuzumab deruxtecan, Drug: TucatinibT-DXd and tucatinib in patients with active brain metastases (Part 2 Only) (Arm not initiated) |
| Module 7 - T-DXd | Experimental | Drug: Trastuzumab deruxtecanT-DXd monotherapy in patients with active brain metastases (Part 2 Only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must be at least 18 years of age
- Pathologically documented breast cancer that:
- Patient must have adequate tumor sample from the metastatic setting for biomarker assessment
- ECOG Performance Status of 0 or 1
- Part 1
Key exclusion criteria (11 listed)
- Uncontrolled or significant cardiovascular disease
- Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Lung-specific intercurrent clinically significant illnesses
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Spinal cord compression or a history of leptomeningeal carcinomatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab deruxtecanAlso: DS-8201a, T-DXdT-DXd: administered as an IV infusion | Drug | Module 0- T-DXd, Module 1- T-DXd and Durvalumab, Module 2- T-DXd and Pertuzumab, Module 3- T-DXd and Paclitaxel, Module 4- T-DXd and Durvalumab and Paclitaxel, Module 5 - T-DXd and Tucatanib, Module 6 - T-DXd and Tucatinib, Module 7 - T-DXd |
| DurvalumabAlso: MEDI4736Durvalumab: administered as an IV infusion | Drug | Module 1- T-DXd and Durvalumab, Module 4- T-DXd and Durvalumab and Paclitaxel |
| PaclitaxelPaclitaxel: administered as an IV infusion | Drug | Module 3- T-DXd and Paclitaxel, Module 4- T-DXd and Durvalumab and Paclitaxel |
| PertuzumabPertuzumab: administered as an IV infusion | Drug | Module 2- T-DXd and Pertuzumab |
| TucatinibAlso: ONT-380Tucatinib administered orally (tablet) twice daily | Drug | Module 5 - T-DXd and Tucatanib, Module 6 - T-DXd and Tucatinib |
Primary outcome
Occurrence of adverse events (AEs)- Part 1
Time frame: Up to follow-up period, approximately 53 months
Occurrence of AEs in Part 1 graded according to NCI CTCAE v5.0
Occurrence of serious adverse events (SAEs)- Part 1
Time frame: Up to follow-up period, approximately 53 months
Occurrence of SAEs in Part 1 graded according to NCI CTCAE v5.0
Occurrence of adverse events (AEs)- Part 2
Time frame: Up to follow-up period, approximately 53 months
Occurrence of AEs in Part 2 graded according to NCI CTCAE v5.0
Occurrence of serious adverse events (SAEs)- Part 2
Time frame: Up to follow-up period, approximately 53 months
Occurrence of SAEs in Part 2 graded according to NCI CTCAE v5.0
13 secondary outcomes
Objective Response Rate (ORR)- Part 1 and Part 2
Time frame: Until progression, assessed up to approximately 53 months
Progression Free Survival (PFS)- Part 1 and Part 2
Time frame: Until progression, assessed up to approximately 53 months
Progression Free Survival 2 (PFS2)- Part 2
Time frame: Assessed up to approximately 53 months
Duration of Response (DoR)- Part 2
Time frame: Until progression, assessed up to approximately 53 months
Overall Survival (OS)- Part 2
Time frame: Until death, assessed up to approximately 53 months
Serum Concentration of Trastuzumab Deruxtecan (T-DXd)
Time frame: While on study drug up to study completion, approximately 53 months
Serum Concentration of Durvalumab
Time frame: While on study drug up to study completion, approximately 53 months
Serum Concentration of Pertuzumab
Time frame: While on study drug up to study completion, approximately 53 months
Plasma Concentration of Paclitaxel
Time frame: While on study drug up to study completion, approximately 53 months
Plasma Concentration of Tucatinib
Time frame: While on study drug up to study completion, approximately 53 months
Immunogenicity of trastuzumab deruxtecan
Time frame: Up to follow-up period, approximately 53 months
Immunogenicity of Durvalumab
Time frame: Up to follow-up period, approximately 53 months
Immunogenicity of Pertuzumab
Time frame: Up to follow-up period, approximately 53 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
72 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trastuzumab deruxtecan, Durvalumab and Paclitaxel in people with Metastatic Breast Cancer, run by AstraZeneca at 72 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Russia, Brazil, Taiwan, South Korea and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (AEs)- Part 1 (time frame: Up to follow-up period, approximately 53 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 4 Nov 2026.