NCT04494425

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
866

participants targeted

Target at P75+ for phase_3

Timeline
2mo left

Started Jul 2020

Longer than P75 for phase_3

Geographic Reach
27 countries

286 active sites

Status
active not recruiting

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

Study Progress98%
Jul 2020Jun 2026

First Submitted

Initial submission to the registry

July 20, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

July 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 2, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2026

Expected
Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

July 20, 2020

Results QC Date

March 13, 2025

Last Update Submit

February 12, 2026

Conditions

Keywords

Breast CancerHR positiveHER2-LowHER2-NegativeTrastuzumab Deruxtecan (T-DXd; DS-8201a)Anti-HER2-Antibody Drug Conjugate (ADC)DESTINY-Breast06

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

EXPERIMENTAL

Trastuzumab deruxtecan (T-DXd; DS-8201a) arm

Drug: Trastuzumab deruxtecan

Standard of Care

ACTIVE COMPARATOR

Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm

Drug: CapecitabineDrug: PaclitaxelDrug: Nab-Paclitaxel

Interventions

Trastuzumab deruxtecan by intravenous infusion

Also known as: DS-8201a; T-DXd
Trastuzumab deruxtecan

Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.

Standard of Care

Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.

Standard of Care

Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion

Standard of Care

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

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

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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.

  • Tarantino 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.

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecanCapecitabinePaclitaxel130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

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
Model Details: The study consists of 2 independent open label treatment arms: trastuzumab deruxtecan and Investigator's choice chemotherapy (paclitaxel, nab-paclitaxel or capecitabine).
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

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.

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.
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