AzTrials
AzTrials

Advanced or Metastatic Breast CancerPhase 3DB-06NCT04494425

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

A Phase 3 study testing Trastuzumab deruxtecan, Capecitabine and Paclitaxel in people with Advanced or Metastatic Breast Cancer, run by AstraZeneca at 293 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 105 years
Conditions the study is for
Advanced or Metastatic Breast Cancer
What is being tested?
Trastuzumab deruxtecan, Capecitabine and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
866 participants
Where
293 sitesin 28 countries
Study dates
24 Jul 2020to 19 Jun 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

293 sites in 28 countries.

293 sites in 28 countries

China32 sites

  • Research Site

    Baoding, 071000

  • Research Site

    Beijing, 100006

  • Research Site

    Beijing, 100044

  • Research Site

    Changchun, 130021

  • Research Site

    Changsha, 410008

  • Research Site

    Changsha, 410013

  • Research Site

    Dalian, 116001

  • Research Site

    Foshan, 528000

  • Research Site

    Fuzhou, 350011

  • Research Site

    Guangzhou, 510060

  • Research Site

    Guangzhou, 510080

  • Research Site

    Guangzhou, 510120

  • Research Site

    Hangzhou, 310003

  • Research Site

    Hangzhou, 310020

  • Research Site

    Hangzhou, 310022

  • Research Site

    Harbin, 150081

  • Research Site

    Hefei, 230001

  • Research Site

    Jinan, 250001

  • Research Site

    Linyi, 276000

  • Research Site

    Nanchang, 330006

  • Research Site

    Nanchang, 330009

  • Research Site

    Nanjing, 210009

  • Research Site

    Nanjing, 210029

  • Research Site

    Nanning, 530021

  • Research Site

    Shanghai, 200032

  • Research Site

    Shenyang, 110015

  • Research Site

    Tianjin, 300060

  • Research Site

    Ürümqi, 830000

  • Research Site

    Wuhan, 430079

  • Research Site

    Xi'an, 710004

  • Research Site

    Xi'an, 710061

  • Research Site

    Zhengzhou, 450008

Other trials in China

Japan29 sites

  • Research Site

    Akashi-shi, 673-8558

  • Research Site

    Bunkyō City, 113-8431

  • Research Site

    Chiba, 260-8717

  • Research Site

    Chūōku, 104-0045

  • Research Site

    Fukuoka, 811-1395

  • Research Site

    Gifu, 501-1194

  • Research Site

    Hidaka-shi, 350-1298

  • Research Site

    Hiroshima, 730-8518

  • Research Site

    Isehara, 259-1193

  • Research Site

    Kagoshima, 892-0833

  • Research Site

    Kashiwa, 277-8577

  • Research Site

    Kawasaki-shi, 216-8511

  • Research Site

    Kitaadachi-gun, 362-0806

  • Research Site

    Kōtoku, 135-8550

  • Research Site

    Matsuyama, 791-0280

  • Research Site

    Nagoya, 460-0001

  • Research Site

    Naha, 901-0154

  • Research Site

    Niigata, 951-8566

  • Research Site

    Nishinomiya-shi, 663-8501

  • Research Site

    Okayama, 700-8558

  • Research Site

    Osaka, 541-8567

  • Research Site

    Osakasayama-shi, 589-8511

  • Research Site

    Sagamihara-shi, 252-0375

  • Research Site

    Sapporo, 060-8648

  • Research Site

    Shinagawa-ku, 142-8666

  • Research Site

    Shinjuku-ku, 160-0023

  • Research Site

    Shizuoka, 420-8527

  • Research Site

    Tsu, 514-8507

  • Research Site

    Yokohama, 241-8515

Other trials in Japan

United States27 sites

  • Research Site

    Aurora, Colorado, 80045

  • Research Site

    Austin, Texas, 78731

  • Research Site

    Bethesda, Maryland, 20817

  • Research Site

    Boston, Massachusetts, 02114

  • Research Site

    Columbus, Ohio, 43210

  • Research Site

    Dallas, Texas, 75246

  • Research Site

    Detroit, Michigan, 48202

  • Research Site

    Duarte, California, 91010

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Houston, Texas, 77090

  • Research Site

    Jacksonville, Florida, 32224

  • Research Site

    Kansas City, Kansas, 66160

  • Research Site

    Lakewood, Colorado, 80228

  • Research Site

    Los Angeles, California, 90017

  • Research Site

    Louisville, Kentucky, 40202

  • Research Site

    Madison, Wisconsin, 53792-5666

  • Research Site

    Nashville, Tennessee, 37232

  • Research Site

    Norfolk, Virginia, 23502

  • Research Site

    Pittsburgh, Pennsylvania, 15212

  • Research Site

    Rochester, Minnesota, 55905

  • Research Site

    Scottsdale, Arizona, 85259

  • Research Site

    Seattle, Washington, 98104

  • Research Site

    Springdale, Arkansas, 72762

  • Research Site

    St Louis, Missouri, 63110

  • Research Site

    Summit, New Jersey, 07901

  • Research Site

    Washington D.C., District of Columbia, 20016

  • Research Site

    Westbury, New York, 11590

Other trials in United States

France18 sites

  • Research Site

    Avignon, 84918

  • Research Site

    Besançon, 25000

  • Research Site

    Bordeaux, 33000

  • Research Site

    Brest, 29609

  • Research Site

    Caen, 14076

  • Research Site

    Dijon, 21079

  • Research Site

    Le Mans, 72000

  • Research Site

    Marseille, 13273

  • Research Site

    Montpellier, 34298

  • Research Site

    Nice, 06100

  • Research Site

    Paris, 75005

  • Research Site

    Pierre-Bénite, 69495

  • Research Site

    Plerin SUR MER, 22190

  • Research Site

    Rennes, 35000

  • Research Site

    Saint-Cloud, 92210

  • Research Site

    Saint-Herblain, 44805

  • Research Site

    Tours, 37000

  • Research Site

    Villejuif, 94805

Other trials in France

Italy15 sites

  • Research Site

    Aviano, 33081

  • Research Site

    Bergamo, 24127

  • Research Site

    Candiolo, 10060

  • Research Site

    Cona, 44124

  • Research Site

    Genova, 16132

  • Research Site

    Livorno, 57124

  • Research Site

    Messina, 98158

  • Research Site

    Milan, 20141

  • Research Site

    Milan, 20132

  • Research Site

    Naples, 80131

  • Research Site

    Padova, 35128

  • Research Site

    Parma

  • Research Site

    Prato, 59100

  • Research Site

    Tricase, Lecce, 73039

  • Research Site

    Udine, 33100

Other trials in Italy

Spain12 sites

  • Research Site

    A Coruña, 15006

  • Research Site

    Barcelona, 08035

  • Research Site

    Barcelona, 08036

  • Research Site

    Barcelona, 08907

  • Research Site

    Córdoba, 14004

  • Research Site

    El Palmar, 30120

  • Research Site

    Madrid, 28005

  • Research Site

    Madrid, 28007

  • Research Site

    Madrid, 28046

  • Research Site

    San Sebastián, 20014

  • Research Site

    Seville, 41013

  • Research Site

    Valencia, 46026

Other trials in Spain

Argentina10 sites

  • Research Site

    Buenos Aires, C1125ABD

  • Research Site

    CABA, 1414

  • Research Site

    CABA, C1012AAR

  • Research Site

    CABA, C1019ABS

  • Research Site

    Ciudad de Buenos Aires, 1280

  • Research Site

    Córdoba, 5000

  • Research Site

    La Plata, 1900

  • Research Site

    Mar del Plata, 7600

  • Research Site

    Rosario, S2000DEJ

  • Research Site

    Rosario, S2002KDS

Other trials in Argentina

Belgium10 sites

  • Research Site

    Anderlecht, 1070

  • Research Site

    Brussels, 1200

  • Research Site

    Charleroi, 6060

  • Research Site

    Edegem, 2650

  • Research Site

    Ghent, 9000

  • Research Site

    Leuven, 3000

  • Research Site

    Liège, 4000

  • Research Site

    Namur, 5000

  • Research Site

    Roeselare, 8800

  • Research Site

    Sint-Niklaas, 9100

Other trials in Belgium

Canada10 sites

  • Research Site

    Calgary, Alberta, T2N 5G2

  • Research Site

    Edmonton, Alberta, T6G 1Z2

  • Research Site

    London, Ontario, N6A 5W9

  • Research Site

    Montreal, Quebec, H3T 1E2

  • Research Site

    Montreal, Quebec, H4A 3J1

  • Research Site

    Sherbrooke, Quebec, J1H 5N4

  • Research Site

    Toronto, CA, M5G 2M9

  • Research Site

    Toronto, Ontario, M4N 3M5

  • Research Site

    Toronto, Ontario, M5G 1X5

  • Research Site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

India10 sites

  • Research Site

    Bengaluru, 560099

  • Research Site

    Calicut, 673601

  • Research Site

    Kolkata, 700160

  • Research Site

    Marg Jaipur, 302004

  • Research Site

    New Delhi, 110 085

  • Research Site

    New Delhi, 110005

  • Research Site

    New Delhi, 110017

  • Research Site

    New Delhi, 110075

  • Research Site

    Surat, 395002

  • Research Site

    Thiruvananthapuram, 695011

Other trials in India

Brazil9 sites

  • Research Site

    Barretos, 14784-400

  • Research Site

    Belo Horizonte, 30110-022

  • Research Site

    Natal, 59075-740

  • Research Site

    Porto Alegre, 90610-000

  • Research Site

    Porto Alegre, 91350-200

  • Research Site

    Rio de Janeiro, 20560-120

  • Research Site

    São Paulo, 04038-034

  • Research Site

    São Paulo, 1323001

  • Research Site

    Sorocaba, 18030-510

Other trials in Brazil

Mexico9 sites

  • Research Site

    Alc. Cuauhtémoc, 06700

  • Research Site

    Guadalajara Jalisco, 44280

  • Research Site

    Guadalajra, 44260

  • Research Site

    México, 04700

  • Research Site

    Mexico City, '14080

  • Research Site

    Mexico City, 0 3100

  • Research Site

    Mexico City, 6760

  • Research Site

    Monterrey, 64460

  • Research Site

    Nuevo León, 66278

Other trials in Mexico

Russia9 sites

  • Research Site

    Krasnodar, 350040

  • Research Site

    Moscow, 111123

  • Research Site

    Moscow, 115478

  • Research Site

    Moscow, 117997

  • Research Site

    Moscow, 121205

  • Research Site

    Saint Petersburg, 190103

  • Research Site

    Saint Petersburg, 195271

  • Research Site

    Saint Petersburg, 197758

  • Research Site

    Yaroslavl, 150054

Other trials in Russia

South Korea9 sites

  • Research Site

    Daegu, 41404

  • Research Site

    Goyang-si, 10408

  • Research Site

    Incheon, 22332

  • Research Site

    Seongnam-si, 13620

  • Research Site

    Seoul, 02841

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03722

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06351

Other trials in South Korea

Germany8 sites

  • Research Site

    Berlin, 10117

  • Research Site

    Dresden, 01307

  • Research Site

    Freiburg im Breisgau, 79110

  • Research Site

    Hanover, 30625

  • Research Site

    München, 81675

  • Research Site

    München, D-80336

  • Research Site

    Münster, 48149

  • Research Site

    Velbert, 42551

Other trials in Germany

Hungary8 sites

  • Research Site

    Budapest, 1062

  • Research Site

    Budapest, 1122

  • Research Site

    Budapest, 1145

  • Research Site

    Győr, 9024

  • Research Site

    Kecskemét, 6000

  • Research Site

    Nyíregyháza, 4400

  • Research Site

    Szolnok, 5000

  • Research Site

    Tatabánya, 2800

Other trials in Hungary

Taiwan8 sites

  • Research Site

    Taichung, 40447

  • Research Site

    Tainan, 70403

  • Research Site

    Tainan, 710

  • Research Site

    Taipei, 10048

  • Research Site

    Taipei, 10449

  • Research Site

    Taipei, 11217

  • Research Site

    Taipei, 235

  • Research Site

    Taoyuan, 333

Other trials in Taiwan

United Kingdom8 sites

  • Research Site

    Cambridge, CB2 0QQ

  • Research Site

    Cardiff, CF14 2TL

  • Research Site

    Edinburgh, EH4 2XR

  • Research Site

    Guildford

  • Research Site

    Leeds, LS9 7TF

  • Research Site

    London, SE1 9RT

  • Research Site

    Manchester, M20 4BX

  • Research Site

    Northwood, HA6 2RN

Other trials in United Kingdom

Australia7 sites

  • Research Site

    Adelaide, 5000

  • Research Site

    Birtinya, 4575

  • Research Site

    Darlinghurst, 2010

  • Research Site

    Murdoch, 6150

  • Research Site

    South Brisbane, 4101

  • Research Site

    St Leonards, 2065

  • Research Site

    Waratah, 2298

Other trials in Australia

Israel7 sites

  • Research Site

    Haifa, 3109601

  • Research Site

    Jerusalem, 9103102

  • Research Site

    Jerusalem, 91120

  • Research Site

    Kfar Saba, 44281

  • Research Site

    Petah Tikva, 49100

  • Research Site

    Ramat Gan, 52621

  • Research Site

    Tel Aviv, 64239

Other trials in Israel

Poland7 sites

  • Research Site

    Bydgoszcz, 85-796

  • Research Site

    Koszalin, 75-581

  • Research Site

    Krakow, 31-501

  • Research Site

    Lodz, 90-302

  • Research Site

    Rzeszów, 35-021

  • Research Site

    Warsaw, 02-781

  • Research Site

    Wroclaw, 53-413

Other trials in Poland

Netherlands6 sites

  • Research Site

    Amsterdam, 1066 CX

  • Research Site

    Breda, 4818 CK

  • Research Site

    Hengelo, 7555 DL

  • Research Site

    Leeuwarden, 8934 AD

  • Research Site

    Rotterdam, 3015 GD

  • Research Site

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

Saudi Arabia6 sites

  • Research Site

    Dammam, 31444

  • Research Site

    Jeddah, 21423

  • Research Site

    Jeddah, 23214

  • Research Site

    Riyadh, 11426

  • Research Site

    Riyadh, 11525

  • Research Site

    Riyadh, 12713

Other trials in Saudi Arabia

Singapore5 sites

  • Research Site

    Bukit Merah, 169610

  • Research Site

    Singapore, 119074

  • Research Site

    Singapore, 258499

  • Research Site

    Singapore, 308433

  • Research Site

    Singapore, 329563

Other trials in Singapore

Sweden5 sites

  • Research Site

    Gothenburg, 413 45

  • Research Site

    Örebro, 701 85

  • Research Site

    Stockholm, 118 83

  • Research Site

    Uppsala, 751 85

  • Research Site

    Vaxjo, 35185

Other trials in Sweden

Denmark4 sites

  • Research Site

    Aalborg, 9000

  • Research Site

    Copenhagen Ø, 2100

  • Research Site

    Odense, 5000

  • Research Site

    Vejle, 7100

Other trials in Denmark

Portugal3 sites

  • Research Site

    Lisbon, 1500-650

  • Research Site

    Lisbon, 1649-035

  • Research Site

    Lisbon, 1998-018

Other trials in Portugal

Austria2 sites

  • Research Site

    Graz, 8036

  • Research Site

    Innsbruck, 6020

Other trials in Austria

About this study

Official title: 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)

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.

Read the detailed description

Eligible patients will be those patients who have had disease progression on at least 2 previous lines of endocrine therapies given for the treatment of metastatic disease or disease progression within 6 months of starting first line treatment for metastatic disease with an endocrine therapy combined with a CDK4/6 inhibitor. All patients must have historically confirmed HR positive (either estrogen receptor and/or progesterone receptor positive), HER2-low (defined as IHC2+/ISH- and IHC 1+) or HER2 IHC >0 <1+ expression, as determined by central laboratory testing results, advanced or metastatic breast cancer.

The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy. This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Being tested
Trastuzumab deruxtecan, Capecitabine, Paclitaxel, Nab-Paclitaxel
Keywords
Breast Cancer, HR positive, HER2-Low, HER2-Negative, Trastuzumab Deruxtecan (T-DXd; DS-8201a), Anti-HER2-Antibody Drug Conjugate (ADC), DESTINY-Breast06
Medical subject headings
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

    Trastuzumab deruxtecan by intravenous infusion

  • CapecitabineDrug

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

  • PaclitaxelDrug

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

  • Nab-PaclitaxelDrug

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

Study groups in NCT04494425
Study groupRoleWhat they receive
Trastuzumab deruxtecanExperimentalTrastuzumab deruxtecan (T-DXd; DS-8201a) arm
Receives: Drug: Trastuzumab deruxtecan
Standard of CareActive comparatorInvestigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm
Receives: Drug: Capecitabine; Drug: Paclitaxel; Drug: Nab-Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Overall Survival (OS) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population

    OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.

    Measured: From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)

  2. 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

    PFS per 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 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 mm from nadir. Median PFS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.

    Measured: 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)

  3. Overall Survival (OS) in the Intent-to-Treat Population

    OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.

    Measured: From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)

  4. Progression-Free Survival Assessed by Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population

    PFS per RECIST 1.1 assessed by Investigator 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 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 mm from nadir. Median PFS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.

    Measured: 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)

  5. 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

    ORR per RECIST 1.1 assessed by BICR and Investigator was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR). CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.

    Measured: 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)

  6. Duration of Response (DOR) Assessed by Blinded Independent Central Review and Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population

    DOR per RECIST v1.1 was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. PD was defined as at least a 20% increase in the sum of diameters of 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 mm from nadir. Median DOR was calculated using Kaplan-Meier method.

    Measured: 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)

  7. Objective Response Rate Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat and Human Epidermal Growth Factor Receptor 2 Immunohistochemistry >0 <1+ Population

    ORR per RECIST 1.1 assessed by BICR and Investigator was defined as the percentage of participants with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.

    Measured: 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)

  8. Duration of Response Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat Population

    DOR per RECIST v1.1 was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. PD was defined as at least a 20% increase in the sum of diameters of 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 mm from nadir. Median DOR was calculated using Kaplan-Meier method.

    Measured: 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)

  9. Time From Randomization to Second Progression or Death (PFS2) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population

    PFS2 was defined as time from randomization to second progression (the earliest of the progression event subsequent to first subsequent therapy) or death; second progression was defined according to local standard clinical practice and might involve any of the following: objective radiological imaging, symptomatic progression, or death. Median PFS2 was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.

    Measured: 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)

  10. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. A serious adverse event (SAE) was an AE occurring during any study phase, that fulfilled 1 or more of following criteria: resulted in death, was immediately life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was congenital abnormality or birth defect, and was an important medical event that jeopardized participant or required medical treatment to prevent 1 of outcomes listed above. TEAE was any AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiation of the study drug until the 40-day (+7 days) safety follow-up visit.

    Measured: From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months)

  11. Serum Concentration of Trastuzumab Deruxtecan (T-DXd), Total Anti-Human Epidermal Growth Factor Receptor 2 Antibody and MAAA-1181a

    Blood samples were collected at indicated time points to determine the concentration of T-DXd, total anti-HER2 antibody and MAAA-1181a in serum.

    Measured: Pre-dose on Day 1 of Cycles 1, 2, 4, 6 and 8; 15 minutes post-dose on Day 1 of Cycles 1, 2 and 4; and 5 hours post-dose on Day 1 of Cycle 1 (each cycle is 21 days)

  12. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scale Score at Week 91

    EORTC QLQ-C30 is a 30-item self-administered questionnaire grouped into 5 multi-item functional scales(physical,role,emotional,cognitive and social),3 multiitem symptom scales(fatigue,pain and nausea/vomiting),2-item global QoL scale,5 single items assessing additional symptoms reported by cancer participants(dyspnea,loss of appetite,insomnia,constipation and diarrhea). All but 2 questions have 4-point scales:1:not at all,2:a little,3:quite a bit,4:very much.2 questions concerning global health status and QoL have 7-point scales with responses ranging from 1:very poor to 7:excellent;higher score:better level of functioning/greater degree of symptoms.For each of 15 scales,final scores were averaged from scores of component items,transformed,range: 0 to 100;higher scores:better functioning,better health related (HR)QoL,or greater level of symptoms(higher scores:opposite interpretations for functioning/QoL and symptoms/problems).Baseline:last observed measurement prior to randomization.

    Measured: Baseline (Day 1) and Week 91

  13. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Breast Module 45 (BR45) Scale Score at Week 58

    EORTC QLQ-BR45 is an updated version of the BR23. Self-administered instrument includes original 23-items yielding 5 multi-item scores (body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects). Additional 22 items yield 4 additional multi-item scales (breast satisfaction, endocrine therapy symptoms, skin mucosis symptoms, and endocrine sexual symptoms). Single items assess sexual enjoyment, future perspective and being upset by hair loss. Items are scored on a 4-point verbal rating scale: 1: not at all, 2: a little, 3: quite a bit, and 4: very much; higher score: better level of functioning or greater degree of symptoms. Scores of these scales were averaged from scores of component items, transformed, and ranged from 0 to 100; higher scores for functioning scales or items indicate better functioning, whereas higher scores for symptom scales or items represent a higher level of symptoms. Baseline:last observed measurement prior to randomization.

    Measured: Baseline (Day 1) and Week 58

  14. Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scale Score

    Time to deterioration was defined as the time from randomization until the date of the first clinically meaningful deterioration that was confirmed at next available assessment, at least 14 days apart, regardless of whether the participant withdrew from study treatment or receives another anti-cancer therapy prior to deterioration.

    Measured: From randomization until date of first symptom deterioration that is confirmed, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)

  15. Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab Deruxtecan

    Blood samples were collected at indicated timepoints to determine ADA. Treatment-induced ADA was defined as ADA positive post-baseline and not detected at baseline (negative or missing). Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following drug administration.

    Measured: From Day 1 up to PCD of 18 March 2024 (maximum of approximately 43.85 months)

  16. Time to First Subsequent Treatment or Death (TFST) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population

    TFST was defined as time from randomization to the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment or death due to any cause.

    Measured: From Day 1 up to 64 months

  17. Time to Second Subsequent Treatment or Death (TSST) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population

    TSST was defined as time from randomization to the start date of the second subsequent anti-cancer therapy after discontinuation of randomized treatment or death due to any cause.

    Measured: From Day 1 up to 64 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2020
  2. Study start24 Jul 2020
  3. Primary completion18 Mar 2024
  4. Study completion19 Jun 2026 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study consists of 2 independent open label treatment arms: trastuzumab deruxtecan and Investigator's choice chemotherapy (paclitaxel, nab-paclitaxel or capecitabine).
Masking
None (open label)
Enrolment
866 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04494425
Sponsor's protocol ID
D9670C00001
Other IDs
2023-505554-18-00, 2019-004493-26, 2019, 2023
Acronym
DB-06
Status last verified
Feb 2026
First submitted
20 Jul 2020
Last updated
4 Mar 2026
Data monitoring committee
Yes
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.

Publications

  • 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.

    PubMed 39282896

  • 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.

    PubMed 37499870

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab deruxtecan, Capecitabine and Paclitaxel in people with Advanced or Metastatic Breast Cancer, run by AstraZeneca at 293 sites in 28 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 13 inclusion and 7 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 293 sites in China, Japan, United States, France, Italy and 23 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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 (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04494425, which also lists 2 linked publications.

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 4 Mar 2026.

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