Metastatic Breast CancerPhase 1DB-08NCT04556773
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
A Phase 1 study testing Trastuzumab deruxtecan, Durvalumab and Paclitaxel in people with Metastatic Breast Cancer, run by AstraZeneca at 37 sites in 10 countries.
Trial summary
DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or 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
- 138 participants
- Where
- 37 sitesin 10 countries
- Study dates
- 17 Dec 2020to 1 Jun 2027
- Phase
- Phase 1
- 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
- Male or female patients who have pathologically documented breast cancer that:
- Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay
- Is documented as HR+ (either ER and/or PgR positive [ER or PgR ≥1%]) or ER and PgR negative (ER and PgR <1%) per ASCO/CAP guidelines in the metastatic setting
- Patient must have adequate tumor sample for biomarker assessment
- ECOG Performance Status of 0 or 1
Show all 12Show fewer
- For patients with HR+ disease:
- Part 1: At least 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors), and at least 1 prior line of chemotherapy for MBC are required.
- Part 2: Only 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors) for MBC is allowed. No prior chemotherapy in the metastatic setting is allowed. Note there are no patients with HR+ disease in Part 2 of Modules 2 and 3.
- For patients with HR- disease:
- Part 1: At least 1 prior line of chemotherapy for MBC is required. Note there are no patients with HR- disease in Part 1 of Modules 4 and 5.
- Part 2: For Module 2, no prior lines of therapy for MBC are allowed, and for Modules 1 and 3, only 1 prior line of chemotherapy for MBC is allowed. Note there are no patients with HR- disease in Part 2 of Modules 4 and 5.
Who cannot join
- Uncontrolled intercurrent illness
- Uncontrolled or siginificant cardiovascular disease
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant illnesses
- Has spinal cord compression or clinically active central nervous system metastases
- Active primary immunodeficiency
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Prior treatment with ADC that comprises of an exatecan derivative that is a topoisomerase I inhibitor.
Trial locations and contacts
37 sites in 10 countries.
37 sites in 10 countries
United States9 sites
Research Site
Chapel Hill, North Carolina, 27514
Research Site
Chattanooga, Tennessee, 37404
Research Site
Commack, New York, 11725
Research Site
Fort Worth, Texas, 76104
Research Site
Germantown, Tennessee, 38138
Research Site
Harrison, New York, 10604
Research Site
New York, New York, 10029
Research Site
New York, New York, 10065
Research Site
Uniondale, New York, 11553
Taiwan7 sites
Research Site
Kaohsiung City, 82445
Research Site
Taichung, 40443
Research Site
Taipei, 100
Research Site
Taipei, 11217
Research Site
Taipei, 114
Research Site
Taipei, 235
Research Site
Taoyuan, 333
Brazil5 sites
Research Site
Goiânia, 74605-070
Research Site
Porto Alegre, 90035-003
Research Site
Porto Alegre, 90110-270
Research Site
São Paulo, 03102-002
Research Site
São Paulo, 04543-000
South Korea4 sites
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Belgium3 sites
Research Site
Edegem, 2650
Research Site
Leuven, 3000
Research Site
Ottignies, 1340
Russia3 sites
Research Site
Moscow, 115478
Research Site
Moscow, 143442
Research Site
Saint Petersburg, 199226
Canada2 sites
Research Site
Kelowna, British Columbia, V1Y 5L3
Research Site
Québec, Quebec, G1J 1Z4
About this study
Official title: A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With Metastatic HER2-low Breast Cancer (DESTINY-Breast08)
DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer
Read the detailed description
This study is modular in design allowing assessment of the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies. Combination-treatment modules will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the Part 2 dose-expansion phase will use the RP2D determined in Part 1.
The target population of interest in this study is patients with HER2-low (IHC 1+ or IHC 2+/ISH -) (as per ASCO/CAP 2018 guidelines) advanced/MBC. Part 1 of each module will enroll patients with locally confirmed HER2-low advanced/MBC in second-line or later (≥ 2L) settings
Part 2 of each module will enroll patients with HER2-low MBC who have either not received prior treatment, or received only 1 prior treatment (depending on the module-specific exclusion criteria) for advanced/metastatic disease
- Conditions
- Metastatic Breast Cancer
- Being tested
- Trastuzumab deruxtecan, Durvalumab, Paclitaxel, Capivasertib, Anastrozole
- Keywords
- Breast Cancer, HER2-negative, HER2-low, Trastuzumab Deruxtecan, T-DXd, DS-8201a, DESTINY-Breast08, Anti-HER2 Antibody Drug Conjugate (ADC), Triple-negative breast cancer (TNBC)
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast 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
Also called Taxol A
Paclitaxel: administered as an IV infusion
CapivasertibDrug
Also called AZD5363
Capivasertib: administered orally
AnastrozoleDrug
Also called Anastrozol
Anastrozole: administered orally
FulvestrantDrug
Fulvestrant: administered as an IM injection
CapecitabineDrug
Capecitabine: administered orally
| Study group | Role | What they receive |
|---|---|---|
| Module 1: T-DXd + capecitabine | Experimental | T-DXd: 5.4 mg/kg Q3W, intravenous use Capecitabine: 1000mg/m2 BID, days 1-14 Q3W, oral use Receives: Drug: Trastuzumab deruxtecan; Drug: Capecitabine |
| Module 2: T-DXd + durvalumab + paclitaxel | Experimental | T-DXd: 5.4 mg/kg Q3W, intravenous use Durvalumab: 1120 mg Q3W, intravenous use Paclitaxel: 80 mg/m2 QW in 3-week cycles, intravenous use Receives: Drug: Trastuzumab deruxtecan; Drug: Durvalumab; Drug: Paclitaxel |
| Module 3: T-DXd + capivasertib | Experimental | T-DXd: 5.4 mg/kg Q3W, intravenous use Capivasertib: 400 mg BID, oral use Receives: Drug: Trastuzumab deruxtecan; Drug: Capivasertib |
| Module 4: T-DXd + anastrozole | Experimental | T-DXd: 5.4 mg/kg Q3W, intravenous use Anastrozole: 1 mg daily, oral Receives: Drug: Trastuzumab deruxtecan; Drug: Anastrozole |
| Module 5: T-DXd + fulvestrant | Experimental | T-DXd: 5.4 mg/kg Q3W, intravenous use Fulvestrant: 500 mg Q4W, intramuscular use Receives: Drug: Trastuzumab deruxtecan; Drug: Fulvestrant |
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 24 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 24 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 24 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 24 months
Secondary outcomes (8)
Objective Response Rate (ORR)- Part 2
ORR defined as the proportion of patients who have a confirmed CR or PR, as determined by the investigator at local site per RECIST 1.1
Measured: Until progression, assessed up to approximately 24 months
Progression Free Survival (PFS)- Part 2
PFS defined as time from the date of first dose until the date of progression as determined by the investigator at local site per RECIST 1.1, or death due to any cause
Measured: Until progression or death, assessed up to approximately 24 months
Duration of Response (DoR)- Part 2
DoR defined as time from the date of first documented response (which is subsequently confirmed) until the date of documented progression or death in the absence of disease progression
Measured: Until progression or death, assessed up to approximately 24 months
Overall Survival (OS)- Part 2
OS defined as time from the date of first dose until the date of death by any cause
Measured: Until death, assessed up to approximately 24 months
Serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181a
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 24 months
Immunogenicity of trastuzumab deruxtecan
Percentage of patients who develop ADA for trastuzumab deruxtecan
Measured: Up to follow-up period, approximately 24 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 24 months
Immunogenicity of durvalumab
Percentage of patients who develop ADAs for durvalumab
Measured: Up to follow-up period, approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start17 Dec 2020
- Primary completion16 Aug 2023
- Study completion1 Jun 2027 (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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will initially consist of 5 treatment modules, each of which includes T-DXd in combination with other anti-cancer agents. Each module will have 2 parts: a dose-finding phase (Part 1) and a dose-expansion phase (Part 2). The Part 2 dose-expansion phase will use the recommended Phase 2 dose (RP2D) for the combination, either as determined in Part 1 or from another clinical study if appropriate. For each module, patients will be centrally assigned to one of the open modules, as per the module specific criteria. In addition to safety and tolerability, this study will also assess ORR, PFS, DoR, and OS for each treatment combination.
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd., Daiichi Sankyo Company, Limited
- Responsible party
- Sponsor
- Investigators
- Komal Jhaveri, MD, FACP, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556773
- Sponsor's protocol ID
- D967JC00002
- Other IDs
- 2023-505690-33-00, 2020-002797-27, 2023
- Acronym
- DB-08
- Status last verified
- Jul 2026
- First submitted
- 15 Sep 2020
- Last updated
- 3 Aug 2026
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With Metastatic HER2-low Breast Cancer (DESTINY-Breast08)
- ClinicalTrials.gov ID
- NCT04556773
- Acronym / sponsor ID
- DB-08 / D967JC00002
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer, HER2-negative, HER2-low, Trastuzumab Deruxtecan, T-DXd, DS-8201a, DESTINY-Breast08, Anti-HER2 Antibody Drug Conjugate (ADC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 138 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd., Daiichi Sankyo Company, Limited
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 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-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer
Detailed description
This study is modular in design allowing assessment of the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies. Combination-treatment modules will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the Part 2 dose-expansion phase will use the RP2D determined in Part 1.
The target population of interest in this study is patients with HER2-low (IHC 1+ or IHC 2+/ISH -) (as per ASCO/CAP 2018 guidelines) advanced/MBC. Part 1 of each module will enroll patients with locally confirmed HER2-low advanced/MBC in second-line or later (≥ 2L) settings
Part 2 of each module will enroll patients with HER2-low MBC who have either not received prior treatment, or received only 1 prior treatment (depending on the module-specific exclusion criteria) for advanced/metastatic disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The study will initially consist of 5 treatment modules, each of which includes T-DXd in combination with other anti-cancer agents. Each module will have 2 parts: a dose-finding phase (Part 1) and a dose-expansion phase (Part 2). The Part 2 dose-expansion phase will use the recommended Phase 2 dose (RP2D) for the combination, either as determined in Part 1 or from another clinical study if appropriate. For each module, patients will be centrally assigned to one of the open modules, as per the module specific criteria. In addition to safety and tolerability, this study will also assess ORR, PFS, DoR, and OS for each treatment combination.
| Arm | Type | Receives |
|---|---|---|
| Module 1: T-DXd + capecitabine | Experimental | Drug: Trastuzumab deruxtecan, Drug: CapecitabineT-DXd: 5.4 mg/kg Q3W, intravenous use Capecitabine: 1000mg/m2 BID, days 1-14 Q3W, oral use |
| Module 2: T-DXd + durvalumab + paclitaxel | Experimental | Drug: Trastuzumab deruxtecan, Drug: Durvalumab, Drug: PaclitaxelT-DXd: 5.4 mg/kg Q3W, intravenous use Durvalumab: 1120 mg Q3W, intravenous use Paclitaxel: 80 mg/m2 QW in 3-week cycles, intravenous use |
| Module 3: T-DXd + capivasertib | Experimental | Drug: Trastuzumab deruxtecan, Drug: CapivasertibT-DXd: 5.4 mg/kg Q3W, intravenous use Capivasertib: 400 mg BID, oral use |
| Module 4: T-DXd + anastrozole | Experimental | Drug: Trastuzumab deruxtecan, Drug: AnastrozoleT-DXd: 5.4 mg/kg Q3W, intravenous use Anastrozole: 1 mg daily, oral |
| Module 5: T-DXd + fulvestrant | Experimental | Drug: Trastuzumab deruxtecan, Drug: FulvestrantT-DXd: 5.4 mg/kg Q3W, intravenous use Fulvestrant: 500 mg Q4W, intramuscular use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must be at least 18 years of age
- Male or female patients who have pathologically documented breast cancer that:
- Patient must have adequate tumor sample for biomarker assessment
- ECOG Performance Status of 0 or 1
- Part 1: At least 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors), and at least 1 prior line of chemotherapy for MBC are required.
Key exclusion criteria (8 listed)
- Uncontrolled intercurrent illness
- Uncontrolled or siginificant cardiovascular disease
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant illnesses
- Has spinal cord compression or clinically active central nervous system metastases
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 1: T-DXd + capecitabine, Module 2: T-DXd + durvalumab + paclitaxel, Module 3: T-DXd + capivasertib, Module 4: T-DXd + anastrozole, Module 5: T-DXd + fulvestrant |
| DurvalumabAlso: MEDI4736Durvalumab: administered as an IV infusion | Drug | Module 2: T-DXd + durvalumab + paclitaxel |
| PaclitaxelAlso: Taxol APaclitaxel: administered as an IV infusion | Drug | Module 2: T-DXd + durvalumab + paclitaxel |
| CapivasertibAlso: AZD5363Capivasertib: administered orally | Drug | Module 3: T-DXd + capivasertib |
| AnastrozoleAlso: AnastrozolAnastrozole: administered orally | Drug | Module 4: T-DXd + anastrozole |
| FulvestrantFulvestrant: administered as an IM injection | Drug | Module 5: T-DXd + fulvestrant |
| CapecitabineCapecitabine: administered orally | Drug | Module 1: T-DXd + capecitabine |
Primary outcome
Occurrence of adverse events (AEs)- Part 1
Time frame: Up to follow-up period, approximately 24 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 24 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 24 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 24 months
Occurrence of SAEs in Part 2 graded according to NCI CTCAE v5.0
8 secondary outcomes
Objective Response Rate (ORR)- Part 2
Time frame: Until progression, assessed up to approximately 24 months
Progression Free Survival (PFS)- Part 2
Time frame: Until progression or death, assessed up to approximately 24 months
Duration of Response (DoR)- Part 2
Time frame: Until progression or death, assessed up to approximately 24 months
Overall Survival (OS)- Part 2
Time frame: Until death, assessed up to approximately 24 months
Serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181a
Time frame: While on study drug up to study completion, approximately 24 months
Immunogenicity of trastuzumab deruxtecan
Time frame: Up to follow-up period, approximately 24 months
Serum Concentration of durvalumab
Time frame: While on study drug up to study completion, approximately 24 months
Immunogenicity of durvalumab
Time frame: Up to follow-up period, approximately 24 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 3 Aug 2026.
- AstraZeneca Breast Cancer Study Locator website - To learn which AstraZeneca breast cancer clinical trials are looking for participants with specific diagnosis, stage, and treatment history.Link provided by the sponsor.
- redacted Study Synopsis (core + module 1-5 (combined)Link 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.
Komal Jhaveri, MD, FACP principal investigator
Memorial Sloan Kettering Cancer Center
37 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trastuzumab deruxtecan, Durvalumab and Paclitaxel in people with Metastatic Breast Cancer, run by AstraZeneca at 37 sites in 10 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 12 inclusion and 8 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Taiwan, Brazil, South Korea, Belgium and 5 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 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.
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 24 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 3 Aug 2026.