Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
DB-06
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
3 other identifiers
interventional
866
27 countries
286
Brief Summary
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2020
Longer than P75 for phase_3
286 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2020
CompletedStudy Start
First participant enrolled
July 24, 2020
CompletedFirst Posted
Study publicly available on registry
July 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2024
CompletedResults Posted
Study results publicly available
April 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2026
ExpectedMarch 4, 2026
February 1, 2026
3.7 years
July 20, 2020
March 13, 2025
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population
PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 millimeter (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.
Response evaluations performed at screening, every 6 weeks (q6w) ± 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary Outcomes (17)
Overall Survival (OS) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Progression-Free Survival Assessed by Blinded Independent Central Review in the Intent-to-Treat, Human Epidermal Growth Factor Receptor 2 Immunohistochemistry (IHC) >0 <1+ and Human Epidermal Growth Factor Receptor 2-low Population
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Overall Survival (OS) in the Intent-to-Treat Population
From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Progression-Free Survival Assessed by Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
- +12 more secondary outcomes
Study Arms (2)
Trastuzumab deruxtecan
EXPERIMENTALTrastuzumab deruxtecan (T-DXd; DS-8201a) arm
Standard of Care
ACTIVE COMPARATORInvestigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm
Interventions
Trastuzumab deruxtecan by intravenous infusion
Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.
Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.
Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion
Eligibility Criteria
You may qualify if:
- Patients must be ≥18 years of age
- Pathologically documented breast cancer that:
- is advanced or metastatic
- has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)
- has HER2-low or HER2 IHC \>0 \<1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic setting
- was never previously HER2-positive
- is documented HR+ disease in the metastatic setting.
- No prior chemotherapy for advanced or metastatic breast cancer.
- Has adequate tumor samples for assessment of HER2 status
- Must have either:
- disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or
- disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the ≥2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting.
- Has protocol-defined adequate organ and bone marrow function
You may not qualify if:
- Ineligible for all options in the investigator's choice chemotherapy arm
- Lung-specific intercurrent clinically significant illnesses
- Uncontrolled or significant cardiovascular disease or infection
- Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening.
- Patients with spinal cord compression or clinically active central nervous system metastases
- Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyocollaborator
Study Sites (293)
Research Site
Scottsdale, Arizona, 85259, United States
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Springdale, Arkansas, 72762, United States
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Duarte, California, 91010, United States
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Los Angeles, California, 90017, United States
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Aurora, Colorado, 80045, United States
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Lakewood, Colorado, 80228, United States
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Washington D.C., District of Columbia, 20016, United States
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Jacksonville, Florida, 32224, United States
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Kansas City, Kansas, 66160, United States
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Louisville, Kentucky, 40202, United States
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Bethesda, Maryland, 20817, United States
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Boston, Massachusetts, 02114, United States
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Detroit, Michigan, 48202, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Summit, New Jersey, 07901, United States
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Westbury, New York, 11590, United States
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Columbus, Ohio, 43210, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78731, United States
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Dallas, Texas, 75246, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77090, United States
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Norfolk, Virginia, 23502, United States
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Seattle, Washington, 98104, United States
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Madison, Wisconsin, 53792-5666, United States
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Buenos Aires, C1125ABD, Argentina
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CABA, 1414, Argentina
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CABA, C1012AAR, Argentina
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CABA, C1019ABS, Argentina
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Ciudad de Buenos Aires, 1280, Argentina
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Córdoba, 5000, Argentina
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La Plata, 1900, Argentina
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Mar del Plata, 7600, Argentina
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Rosario, S2000DEJ, Argentina
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Rosario, S2002KDS, Argentina
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Adelaide, 5000, Australia
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Birtinya, 4575, Australia
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Darlinghurst, 2010, Australia
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Murdoch, 6150, Australia
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South Brisbane, 4101, Australia
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St Leonards, 2065, Australia
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Waratah, 2298, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Anderlecht, 1070, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6060, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Roeselare, 8800, Belgium
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Sint-Niklaas, 9100, Belgium
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Barretos, 14784-400, Brazil
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Belo Horizonte, 30110-022, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 20560-120, Brazil
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São Paulo, 04038-034, Brazil
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São Paulo, 1323001, Brazil
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Sorocaba, 18030-510, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Toronto, CA, M5G 2M9, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Baoding, 071000, China
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Beijing, 100006, China
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Beijing, 100044, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 410013, China
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Dalian, 116001, China
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Foshan, 528000, China
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Fuzhou, 350011, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Guangzhou, 510120, China
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Hangzhou, 310003, China
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Hangzhou, 310020, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230001, China
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Jinan, 250001, China
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Linyi, 276000, China
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Nanchang, 330006, China
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Nanchang, 330009, China
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Nanjing, 210009, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Shanghai, 200032, China
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Shenyang, 110015, China
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Tianjin, 300060, China
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Ürümqi, 830000, China
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Wuhan, 430079, China
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Xi'an, 710004, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Aalborg, 9000, Denmark
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Copenhagen Ø, 2100, Denmark
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Odense, 5000, Denmark
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Vejle, 7100, Denmark
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Avignon, 84918, France
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Besançon, 25000, France
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Bordeaux, 33000, France
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Brest, 29609, France
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Caen, 14076, France
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Dijon, 21079, France
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Le Mans, 72000, France
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Marseille, 13273, France
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Montpellier, 34298, France
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Nice, 06100, France
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Paris, 75005, France
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Pierre-Bénite, 69495, France
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Plerin SUR MER, 22190, France
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Rennes, 35000, France
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Saint-Cloud, 92210, France
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Saint-Herblain, 44805, France
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Tours, 37000, France
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Villejuif, 94805, France
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Berlin, 10117, Germany
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Dresden, 01307, Germany
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Freiburg im Breisgau, 79110, Germany
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Hanover, 30625, Germany
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München, 81675, Germany
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München, D-80336, Germany
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Münster, 48149, Germany
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Velbert, 42551, Germany
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Budapest, 1062, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Győr, 9024, Hungary
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Kecskemét, 6000, Hungary
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Nyíregyháza, 4400, Hungary
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Szolnok, 5000, Hungary
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Tatabánya, 2800, Hungary
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Bengaluru, 560099, India
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Calicut, 673601, India
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Kolkata, 700160, India
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Marg Jaipur, 302004, India
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New Delhi, 110 085, India
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New Delhi, 110005, India
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New Delhi, 110017, India
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New Delhi, 110075, India
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Surat, 395002, India
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Thiruvananthapuram, 695011, India
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Haifa, 3109601, Israel
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Jerusalem, 9103102, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Aviano, 33081, Italy
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Bergamo, 24127, Italy
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Candiolo, 10060, Italy
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Cona, 44124, Italy
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Genova, 16132, Italy
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Livorno, 57124, Italy
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Messina, 98158, Italy
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Milan, 20141, Italy
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Milan, 20132, Italy
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Naples, 80131, Italy
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Padua, 35128, Italy
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Parma, Italy
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Prato, 59100, Italy
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Tricase, Lecce, 73039, Italy
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Udine, 33100, Italy
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Akashi-shi, 673-8558, Japan
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Bunkyō City, 113-8431, Japan
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Chiba, 260-8717, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 811-1395, Japan
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Gifu, 501-1194, Japan
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Hidaka-shi, 350-1298, Japan
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Hiroshima, 730-8518, Japan
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Isehara, 259-1193, Japan
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Kagoshima, 892-0833, Japan
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Kashiwa, 277-8577, Japan
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Kawasaki-shi, 216-8511, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 460-0001, Japan
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Naha, 901-0154, Japan
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Niigata, 951-8566, Japan
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Nishinomiya-shi, 663-8501, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Sagamihara-shi, 252-0375, Japan
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Sapporo, 060-8648, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 160-0023, Japan
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Shizuoka, 420-8527, Japan
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Tsu, 514-8507, Japan
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Yokohama, 241-8515, Japan
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Alc. Cuauhtémoc, 06700, Mexico
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Guadalajara Jalisco, 44280, Mexico
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Guadalajra, 44260, Mexico
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Mexico City, '14080, Mexico
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Mexico City, 0 3100, Mexico
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Mexico City, 6760, Mexico
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México, 04700, Mexico
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Monterrey, 64460, Mexico
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Nuevo León, 66278, Mexico
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Amsterdam, 1066 CX, Netherlands
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Breda, 4818 CK, Netherlands
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Hengelo, 7555 DL, Netherlands
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Leeuwarden, 8934 AD, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Sittard-Geleen, 6162 BG, Netherlands
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Bydgoszcz, 85-796, Poland
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Koszalin, 75-581, Poland
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Krakow, 31-501, Poland
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Lodz, 90-302, Poland
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Rzeszów, 35-021, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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Lisbon, 1500-650, Portugal
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Lisbon, 1649-035, Portugal
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Lisbon, 1998-018, Portugal
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Krasnodar, 350040, Russia
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Moscow, 111123, Russia
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Moscow, 121205, Russia
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Saint Petersburg, 190103, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197758, Russia
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Yaroslavl, 150054, Russia
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Dammam, 31444, Saudi Arabia
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Jeddah, 21423, Saudi Arabia
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Jeddah, 23214, Saudi Arabia
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Riyadh, 11426, Saudi Arabia
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Riyadh, 11525, Saudi Arabia
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Riyadh, 12713, Saudi Arabia
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Bukit Merah, 169610, Singapore
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Singapore, 119074, Singapore
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Singapore, 258499, Singapore
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Singapore, 308433, Singapore
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Singapore, 329563, Singapore
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Incheon, 22332, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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A Coruña, 15006, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08907, Spain
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Córdoba, 14004, Spain
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El Palmar, 30120, Spain
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Madrid, 28005, Spain
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Madrid, 28007, Spain
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Madrid, 28046, Spain
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San Sebastián, 20014, Spain
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Seville, 41013, Spain
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Valencia, 46026, Spain
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Gothenburg, 413 45, Sweden
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Örebro, 701 85, Sweden
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Stockholm, 118 83, Sweden
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Uppsala, 751 85, Sweden
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Vaxjo, 35185, Sweden
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Taichung, 40447, Taiwan
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Tainan, 70403, Taiwan
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Tainan, 710, Taiwan
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Taipei, 10048, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 235, Taiwan
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Taoyuan District, 333, Taiwan
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Cambridge, CB2 0QQ, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Edinburgh, EH4 2XR, United Kingdom
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Guildford, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
Related Publications (2)
Bardia A, Hu X, Dent R, Yonemori K, Barrios CH, O'Shaughnessy JA, Wildiers H, Pierga JY, Zhang Q, Saura C, Biganzoli L, Sohn J, Im SA, Levy C, Jacot W, Begbie N, Ke J, Patel G, Curigliano G; DESTINY-Breast06 Trial Investigators. Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer. N Engl J Med. 2024 Dec 5;391(22):2110-2122. doi: 10.1056/NEJMoa2407086. Epub 2024 Sep 15.
PMID: 39282896DERIVEDTarantino P, Tolaney SM, Curigliano G. Trastuzumab deruxtecan (T-DXd) in HER2-low metastatic breast cancer treatment. Ann Oncol. 2023 Oct;34(10):949-950. doi: 10.1016/j.annonc.2023.07.003. Epub 2023 Jul 26. No abstract available.
PMID: 37499870DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This study is an open-label study that will be conducted "Sponsor-blind". To maintain the integrity of the study, Sponsor personnel directly involved in study conduct will not undertake or have access to efficacy data aggregated by treatment group prior to final data readout for the primary endpoint.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2020
First Posted
July 31, 2020
Study Start
July 24, 2020
Primary Completion
March 18, 2024
Study Completion (Estimated)
June 19, 2026
Last Updated
March 4, 2026
Results First Posted
April 2, 2025
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified 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.
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.