Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer (DB-06)

April 11, 2024 updated by: AstraZeneca

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.

Study Overview

Status

Active, not recruiting

Conditions

Advanced or Metastatic Breast Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

866

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1125ABD
    - Research Site
  - Caba, Argentina, C1012AAR
    - Research Site
  - Caba, Argentina, C1019ABS
    - Research Site
  - Caba, Argentina, 1414
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1280
    - Research Site
  - Cordoba, Argentina, 5000
    - Research Site
  - La Plata, Argentina, 1900
    - Research Site
  - Mar del Plata, Argentina, 7600
    - Research Site
  - Rosario, Argentina, S2000DEJ
    - Research Site
  - Rosario, Argentina, S2002KDS
    - Research Site
Australia
- - Adelaide, Australia, 5000
    - Research Site
  - Birtinya, Australia, 4575
    - Research Site
  - Darlinghurst, Australia, 2010
    - Research Site
  - Murdoch, Australia, 6150
    - Research Site
  - South Brisbane, Australia, 4101
    - Research Site
  - St Leonards, Australia, 2065
    - Research Site
  - Waratah, Australia, 2298
    - Research Site
Austria
- - Graz, Austria, 8036
    - Research Site
  - Innsbruck, Austria, 6020
    - Research Site
Belgium
- - Anderlecht, Belgium, 1070
    - Research Site
  - Bruxelles, Belgium, 1200
    - Research Site
  - Charleroi, Belgium, 6000
    - Research Site
  - Edegem, Belgium, 2650
    - Research Site
  - Gent, Belgium, 9000
    - Research Site
  - Leuven, Belgium, 3000
    - Research Site
  - Liège, Belgium, 4000
    - Research Site
  - Namur, Belgium, 5000
    - Research Site
  - Roeselare, Belgium, 8800
    - Research Site
  - Sint-Niklaas, Belgium, 9100
    - Research Site
Brazil
- - Barretos, Brazil, 14784-400
    - Research Site
  - Belo Horizonte, Brazil, 30110-022
    - Research Site
  - Natal, Brazil, 59075-740
    - Research Site
  - Porto Alegre, Brazil, 90610-000
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Research Site
  - Rio de Janeiro, Brazil, 20560-120
    - Research Site
  - Sao Paulo, Brazil, 1323001
    - Research Site
  - Sorocaba, Brazil, 18030-510
    - Research Site
  - São Paulo, Brazil, 04038-034
    - Research Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Research Site
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Research Site
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - Research Site
- CA
  - Toronto, CA, Canada, M5G 2M9
    - Research Site
- Ontario
  - London, Ontario, Canada, N6A 5W9
    - Research Site
  - Toronto, Ontario, Canada, M4N 3M5
    - Research Site
  - Toronto, Ontario, Canada, M5G 1X5
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - Research Site
  - Montreal, Quebec, Canada, H3T 1E2
    - Research Site
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Research Site
China
- - Baoding, China, 071000
    - Research Site
  - Beijing, China, 100044
    - Research Site
  - Beijing, China, 100006
    - Research Site
  - Changchun, China, 130021
    - Research Site
  - Changsha, China, 410013
    - Research Site
  - Changsha, China, 410008
    - Research Site
  - Dalian, China, 116001
    - Research Site
  - Foshan, China, 528000
    - Research Site
  - Fuzhou, China, 350011
    - Research Site
  - Guangzhou, China, 510120
    - Research Site
  - Guangzhou, China, 510080
    - Research Site
  - Guangzhou, China, 510060
    - Research Site
  - Hangzhou, China, 310022
    - Research Site
  - Hangzhou, China, 310003
    - Research Site
  - Hangzhou, China, 310020
    - Research Site
  - Harbin, China, 150001
    - Research Site
  - Hefei, China, 230001
    - Research Site
  - Jinan, China, 250001
    - Research Site
  - Linyi, China, 276000
    - Research Site
  - Nanchang, China, 330006
    - Research Site
  - Nanchang, China, 330009
    - Research Site
  - Nanjing, China, 210009
    - Research Site
  - Nanjing, China, 210029
    - Research Site
  - Nanning, China, 530021
    - Research Site
  - Shanghai, China, 200032
    - Research Site
  - Shenyang, China
    - Research Site
  - Tianjin, China, 300060
    - Research Site
  - Urumqi, China, 830000
    - Research Site
  - Wuhan, China, 430079
    - Research Site
  - Xi'an, China, 710061
    - Research Site
  - Xi'an, China, 710004
    - Research Site
  - Zhengzhou, China, 450008
    - Research Site
Denmark
- - Aalborg, Denmark, 9000
    - Research Site
  - Copenhagen Ø, Denmark, 2100
    - Research Site
  - Odense C, Denmark, 5000
    - Research Site
  - Vejle, Denmark, 7100
    - Research Site
France
- - Avignon Cedex 09, France, 84918
    - Research Site
  - Besançon, France, 25000
    - Research Site
  - Bordeaux, France, 33000
    - Research Site
  - Brest, France, 29609
    - Research Site
  - Caen Cedex 05, France, 14076
    - Research Site
  - Dijon, France, 21079
    - Research Site
  - Le Mans, France, 72000
    - Research Site
  - Marseille, France, 13273
    - Research Site
  - Montpellier, France, 34298
    - Research Site
  - Nice, France, 06100
    - Research Site
  - Paris, France, 75005
    - Research Site
  - Pierre Benite, France, 69495
    - Research Site
  - Plerin SUR MER, France, 22190
    - Research Site
  - Rennes, France, 35000
    - Research Site
  - Saint Herblain Cedex, France, 44805
    - Research Site
  - Saint-cloud, France, 92210
    - Research Site
  - Tours, France, 37000
    - Research Site
  - Villejuif Cedex, France, 94805
    - Research Site
Germany
- - Berlin, Germany, 10117
    - Research Site
  - Dresden, Germany, 01307
    - Research Site
  - Freiburg, Germany, 79110
    - Research Site
  - Hannover, Germany, 30625
    - Research Site
  - München, Germany, 80337
    - Research Site
  - München, Germany, 81675
    - Research Site
  - Münster, Germany, 48149
    - Research Site
  - Velbert, Germany, 42551
    - Research Site
Hungary
- - Budapest, Hungary, 1145
    - Research Site
  - Budapest, Hungary, 1122
    - Research Site
  - Budapest, Hungary, 1062
    - Research Site
  - Győr, Hungary, 9024
    - Research Site
  - Kecskemét, Hungary, 6000
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Research Site
  - Szolnok, Hungary, 5000
    - Research Site
  - Tatabánya, Hungary, 2800
    - Research Site
India
- - Bengaluru, India, 560099
    - Research Site
  - Calicut, India, 673601
    - Research Site
  - Kolkata, India, 700160
    - Research Site
  - Marg Jaipur, India, 302004
    - Research Site
  - New Delhi, India, 110 085
    - Research Site
  - New Delhi, India, 110017
    - Research Site
  - New Delhi, India, 110075
    - Research Site
  - New Delhi, India, 110005
    - Research Site
  - Surat, India, 395002
    - Research Site
  - Thiruvananthapuram, India, 695011
    - Research Site
Israel
- - Haifa, Israel, 3109601
    - Research Site
  - Jerusalem, Israel, 91120
    - Research Site
  - Jerusalem, Israel, 9103102
    - Research Site
  - Kfar-Saba, Israel, 44281
    - Research Site
  - Petah Tikva, Israel, 49100
    - Research Site
  - Ramat Gan, Israel, 52621
    - Research Site
  - Tel-Aviv, Israel, 64239
    - Research Site
Italy
- - Aviano, Italy, 33081
    - Research Site
  - Bergamo, Italy, 24127
    - Research Site
  - Candiolo, Italy, 10060
    - Research Site
  - Cona, Italy, 44124
    - Research Site
  - Genova, Italy, 16132
    - Research Site
  - Livorno, Italy, 57124
    - Research Site
  - Messina, Italy, 98158
    - Research Site
  - Milan, Italy, 20141
    - Research Site
  - Milano, Italy, 20132
    - Research Site
  - Napoli, Italy, 80131
    - Research Site
  - Padova, Italy, 35128
    - Research Site
  - Parma, Italy
    - Research Site
  - Prato, Italy, 59100
    - Research Site
  - Tricase, Lecce, Italy, 73039
    - Research Site
  - Udine, Italy, 33100
    - Research Site
Japan
- - Akashi-shi, Japan, 673-8558
    - Research Site
  - Bunkyo-ku, Japan, 113-8431
    - Research Site
  - Chiba-shi, Japan, 260-8717
    - Research Site
  - Chuo-ku, Japan, 104-0045
    - Research Site
  - Fukuoka-shi, Japan, 811-1395
    - Research Site
  - Gifu-shi, Japan, 501-1194
    - Research Site
  - Hidaka-shi, Japan, 350-1298
    - Research Site
  - Hiroshima-shi, Japan, 730-8518
    - Research Site
  - Isehara, Japan, 259-1193
    - Research Site
  - Kagoshima-shi, Japan, 892-0833
    - Research Site
  - Kashiwa, Japan, 277-8577
    - Research Site
  - Kawasaki-shi, Japan, 216-8511
    - Research Site
  - Kitaadachi-gun, Japan, 362-0806
    - Research Site
  - Koto-ku, Japan, 135-8550
    - Research Site
  - Matsuyama-shi, Japan, 791-0280
    - Research Site
  - Nagoya, Japan, 460-0001
    - Research Site
  - Naha-shi, Japan, 901-0154
    - Research Site
  - Niigata-shi, Japan, 951-8566
    - Research Site
  - Nishinomiya-shi, Japan, 663-8501
    - Research Site
  - Okayama-shi, Japan, 700-8558
    - Research Site
  - Osaka-shi, Japan, 541-8567
    - Research Site
  - Osakasayama-shi, Japan, 589-8511
    - Research Site
  - Sagamihara-shi, Japan, 252-0375
    - Research Site
  - Sapporo-shi, Japan, 060-8648
    - Research Site
  - Shinagawa-ku, Japan, 142-8666
    - Research Site
  - Shinjuku-ku, Japan, 160-0023
    - Research Site
  - Shizuoka, Japan, 420-8527
    - Research Site
  - Tsu-shi, Japan, 514-8507
    - Research Site
  - Yokohama-shi, Japan, 241-8515
    - Research Site
Korea, Republic of
- - Daegu, Korea, Republic of, 41404
    - Research Site
  - Goyang-si, Korea, Republic of, 10408
    - Research Site
  - Incheon, Korea, Republic of, 22332
    - Research Site
  - Seongnam-si, Korea, Republic of, 13620
    - Research Site
  - Seoul, Korea, Republic of, 03722
    - Research Site
  - Seoul, Korea, Republic of, 05505
    - Research Site
  - Seoul, Korea, Republic of, 03080
    - Research Site
  - Seoul, Korea, Republic of, 02841
    - Research Site
  - Seoul, Korea, Republic of, 06351
    - Research Site
Mexico
- - Alc. Cuauhtémoc, Mexico, 06700
    - Research Site
  - Guadalajara Jalisco, Mexico, 44280
    - Research Site
  - Guadalajra, Mexico, 44260
    - Research Site
  - Mexico City, Mexico, 0 3100
    - Research Site
  - Mexico City, Mexico, '14080
    - Research Site
  - Mexico, D.F., Mexico, 6760
    - Research Site
  - Monterrey, Mexico, 64460
    - Research Site
  - México, Mexico, 04700
    - Research Site
  - Nuevo Leon, Mexico, 66278
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1066 CX
    - Research Site
  - Breda, Netherlands, 4818 CK
    - Research Site
  - Hengelo, Netherlands, 7555 DL
    - Research Site
  - Leeuwarden, Netherlands, 8934 AD
    - Research Site
  - Rotterdam, Netherlands, 3015 GD
    - Research Site
  - Sittard-Geleen, Netherlands, 6162 BG
    - Research Site
Poland
- - Bydgoszcz, Poland, 85-796
    - Research Site
  - Koszalin, Poland, 75-581
    - Research Site
  - Kraków, Poland, 31-501
    - Research Site
  - Rzeszów, Poland, 35-021
    - Research Site
  - Warszawa, Poland, 02-781
    - Research Site
  - Wroclaw, Poland, 53-413
    - Research Site
  - Łódź, Poland, 90-302
    - Research Site
Portugal
- - Lisboa, Portugal, 1649-035
    - Research Site
  - Lisboa, Portugal, 1500-650
    - Research Site
  - Lisboa, Portugal, 1998-018
    - Research Site
Russian Federation
- - Krasnodar, Russian Federation, 350040
    - Research Site
  - Moscow, Russian Federation, 115478
    - Research Site
  - Moscow, Russian Federation, 111123
    - Research Site
  - Moscow, Russian Federation, 117997
    - Research Site
  - Moscow, Russian Federation, 121205
    - Research Site
  - Saint Petersburg, Russian Federation, 195271
    - Research Site
  - Saint Petersburg, Russian Federation, 197758
    - Research Site
  - Saint-Petersburg, Russian Federation, 190103
    - Research Site
  - Sankt-Peterburg, Russian Federation, 197758
    - Research Site
  - Yaroslavl, Russian Federation, 150054
    - Research Site
Saudi Arabia
- - Ar Riyāḑ, Saudi Arabia, 11426
    - Research Site
  - Dammam, Saudi Arabia, 31444
    - Research Site
  - Jeddah, Saudi Arabia, 21423
    - Research Site
  - Jeddah, Saudi Arabia, 23214
    - Research Site
  - Riyadh, Saudi Arabia, 11525
    - Research Site
  - Riyadh, Saudi Arabia, 12713
    - Research Site
Singapore
- - Bukit Merah, Singapore, 169610
    - Research Site
  - Singapore, Singapore, 308433
    - Research Site
  - Singapore, Singapore, 258499
    - Research Site
  - Singapore, Singapore, 119074
    - Research Site
  - Singapore, Singapore, 329563
    - Research Site
Spain
- - Barcelona, Spain, 08035
    - Research Site
  - Barcelona, Spain, 08036
    - Research Site
  - Barcelona, Spain, 08907
    - Research Site
  - Cordoba, Spain, 14004
    - Research Site
  - El Palmar, Spain, 30120
    - Research Site
  - La Coruña, Spain, 15006
    - Research Site
  - Madrid, Spain, 28046
    - Research Site
  - Madrid, Spain, 28007
    - Research Site
  - Madrid, Spain, 28005
    - Research Site
  - San Sebastián, Spain, 20014
    - Research Site
  - Sevilla, Spain, 41013
    - Research Site
  - Valencia, Spain, 46026
    - Research Site
Sweden
- - Göteborg, Sweden, 413 45
    - Research Site
  - Stockholm, Sweden, 118 83
    - Research Site
  - Uppsala, Sweden, 751 85
    - Research Site
  - Växjö, Sweden, 35185
    - Research Site
  - Örebro, Sweden, 701 85
    - Research Site
Taiwan
- - Taichung, Taiwan, 40447
    - Research Site
  - Tainan, Taiwan, 70403
    - Research Site
  - Tainan, Taiwan, 710
    - Research Site
  - Taipei, Taiwan, 235
    - Research Site
  - Taipei, Taiwan, 10449
    - Research Site
  - Taipei, Taiwan, 11217
    - Research Site
  - Taipei, Taiwan, 10048
    - Research Site
  - Tao-Yuan, Taiwan, 333
    - Research Site
United Kingdom
- - Cambridge, United Kingdom, CB2 0QQ
    - Research Site
  - Cardiff, United Kingdom, CF14 2TL
    - Research Site
  - Edinburgh, United Kingdom, EH4 2XR
    - Research Site
  - Guildford, United Kingdom
    - Research Site
  - Leeds, United Kingdom, LS9 7TF
    - Research Site
  - London, United Kingdom, SE1 9RT
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Research Site
  - Northwood, United Kingdom, HA6 2RN
    - Research Site
United States
- Arizona
  - Scottsdale, Arizona, United States, 85259
    - Research Site
- Arkansas
  - Springdale, Arkansas, United States, 72762
    - Research Site
- California
  - Duarte, California, United States, 91010
    - Research Site
  - Los Angeles, California, United States, 90017
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Research Site
  - Lakewood, Colorado, United States, 80228
    - Research Site
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - Research Site
- Florida
  - Jacksonville, Florida, United States, 32224
    - Research Site
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Research Site
- Maryland
  - Bethesda, Maryland, United States, 20817
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Research Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Research Site
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Research Site
- New Jersey
  - Summit, New Jersey, United States, 07901
    - Research Site
- New York
  - Westbury, New York, United States, 11590
    - Research Site
- Ohio
  - Columbus, Ohio, United States, 43210
    - Research Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15212
    - Research Site
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Research Site
- Texas
  - Austin, Texas, United States, 78731
    - Research Site
  - Dallas, Texas, United States, 75246
    - Research Site
  - Houston, Texas, United States, 77030
    - Research Site
  - Houston, Texas, United States, 77090
    - Research Site
- Virginia
  - Norfolk, Virginia, United States, 23502
    - Research Site
- Washington
  - Seattle, Washington, United States, 98104
    - Research Site
- Wisconsin
  - Madison, Wisconsin, United States, 53792-5666
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

Patients must be ≥18 years of age
Pathologically documented breast cancer that:
1. is advanced or metastatic
2. 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)
3. 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
4. was never previously HER2-positive
5. 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:
1. disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or
2. 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

Key Exclusion Criteria:

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trastuzumab deruxtecan Trastuzumab deruxtecan (T-DXd; DS-8201a) arm	Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan by intravenous infusion Other Names: DS-8201a; T-DXd
Active Comparator: Standard of Care Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm	Drug: Capecitabine Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally. Drug: Paclitaxel Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion. Drug: Nab-Paclitaxel Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) - in HR+, HER2-low populaton Time Frame: Until progression or death, assessed up to approximately 60 months	Defined as time from date of randomization until the date of objective radiological disease progression by blinded independent central review (BICR) assessment according to RECIST 1.1 or death.	Until progression or death, assessed up to approximately 60 months

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2020

Primary Completion (Actual)

March 18, 2024

Study Completion (Estimated)

June 19, 2026

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 31, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

D9670C00001
2019-004493-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Celgene Corporation

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A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer (VA)

Advanced or Metastatic Solid Tumors | Advanced or Metastatic Breast Cancer

United States
Hoffmann-La Roche

Completed

Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer

HER2-Positive Metastatic Breast Cancer | HER2-Negative Metastatic Breast Cancer | Locally Advanced or Early Breast Cancer

United States
Institut Curie
Rain Oncology Inc

Terminated

Milademetan and Fulvestrant in GATA3-mutant, ER+HER- Advanced or Metastatic Breast Cancer (DEMETER)

Advanced or Metastatic Breast Cancer

France
Kind Pharmaceuticals LLC

Recruiting

A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer

Advanced or Metastatic Breast Cancer

United States
Shanghai Miracogen Inc.

Recruiting

A Study of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)

Advanced or Metastatic Breast Cancer

China
Adlai Nortye Biopharma Co., Ltd.

Completed

Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer

Advanced or Metastatic Breast Cancer

China
Shanghai Pharmaceuticals Holding Co., Ltd

Recruiting

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

Locally Advanced or Metastatic Breast Cancer

China
Institut Paoli-Calmettes
Novartis Pharmaceuticals

Recruiting

Trans-RosaLEE Study: a Biomarker-directed, Translational Study (TransRosaLEE)

Advanced or Metastatic Breast Cancer (BC)

France
Fudan University

Not yet recruiting

Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer

Breast Neoplasms | Locally Advanced or Metastatic Breast Cancer

Clinical Trials on Trastuzumab deruxtecan

AstraZeneca
Daiichi Sankyo

Completed

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer (DESTINY-B12)

Breast Cancer

Denmark, Finland, Italy, Norway, Spain, Sweden, Poland, United States, Canada, Germany, Japan, Netherlands, Portugal, Switzerland, Australia, United Kingdom, Belgium, Ireland
Fudan University

Not yet recruiting

T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients

Triple-Negative Breast Cancer

China
Fudan University

Active, not recruiting

Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer

Breast Cancer

China
AstraZeneca
Daiichi Sankyo Co., Ltd.

Active, not recruiting

Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens (DG-06)

Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

China
Daiichi Sankyo, Inc.
AstraZeneca

Recruiting

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

Breast Cancer

United States
MedSIR
Daiichi Sankyo, Inc.

Not yet recruiting

T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases (TUXEDO-4)

Breast Cancer | Metastatic Breast Cancer
Cancer Trials Ireland

Recruiting

Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study)

HER2-positive Breast Cancer

Ireland
Cancer Institute and Hospital, Chinese Academy...

Not yet recruiting

Trastuzumab Deruxtecan (T-DXd) With Pyrotinib in First-line HER2-positive Unresectable or Metastatic Breast Cancer Trial

Breast Cancer

China
Medical University of Vienna
Daiichi Sankyo, Inc.

Completed

Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases (TUXEDO-1)

Breast Cancer Stage IV

Austria
National Cancer Institute (NCI)

Suspended

Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma

Osteosarcoma | Recurrent Osteosarcoma

United States

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) - in HR+, HER2-low population Time Frame: Until death, assessed up to approximately 60 months	Defined as the time from randomization to death due to any cause	Until death, assessed up to approximately 60 months
Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+) Time Frame: Until progression or death, assessed up to approximately 60 months	PFS by BICR according to RECIST 1.1 in ITT population	Until progression or death, assessed up to approximately 60 months
Overall Survival - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+) Time Frame: Until death, assessed up to approximately 60 months	OS in the ITT population	Until death, assessed up to approximately 60 months
Objective Response Rate (ORR) in HR+, HER-2 low populaton Time Frame: Until progression, assessed up to approximately 60 months	ORR defined as the percentage of patients with at least one visit response of complete or partial response (CR or PR) by BICR and Investigator assessment according to RECIST 1.1.	Until progression, assessed up to approximately 60 months
Duration of response (DoR) - in HR+, HER-2 low populaton Time Frame: Until progression, assessed up to approximately 60 months	DoR defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by BICR and Investigator assessment according to RECIST 1.1	Until progression, assessed up to approximately 60 months
Progression Free Survival by Investigator assessment - in the HR+, HER2-low population Time Frame: Until progression or death, assessed up to approximately 60 months	PFS using investigator assessments according to RECIST 1.1 in the HER2-low population	Until progression or death, assessed up to approximately 60 months
Objective Response Rate (ORR) in the ITT population Time Frame: Until progression, assessed up to approximately 60 months	ORR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population	Until progression, assessed up to approximately 60 months
Duration of response (DoR) - in the ITT population Time Frame: Until progression, assessed up to approximately 60 months	DoR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population	Until progression, assessed up to approximately 60 months
PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population Time Frame: Assessed up to approximately 60 months	PFS2 defined as time from randomisation to second progression or death. TFST defined as a time elapsed from randomization to first subsequent therapy or death. TSST defined as a time elapsed from randomization to second subsequent therapy or death.	Assessed up to approximately 60 months
Safety and tolerability of drugs; number of adverse events (AEs) Time Frame: Up to follow-up period, approximately 60 months	Number of AEs according to NCI-CTCAE Version 5.0 per each treatment arm	Up to follow-up period, approximately 60 months
Serum concentration of trastuzumab deruxtecan Time Frame: Up to Cycle 8, approximately Week 24; each cycle is 21 days	Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration	Up to Cycle 8, approximately Week 24; each cycle is 21 days
Immunogenicity of trastuzumab deruxtecan Time Frame: Up to follow-up period, approximately 60 months	Percentage of patients who develop ADA for trastuzumab deruxtecan	Up to follow-up period, approximately 60 months
Health-related quality of life - EORTC-QLQ-C30 Time Frame: Assessed up to approximately 60 months	Change from baseline in the physical functioning subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.	Assessed up to approximately 60 months
Time to deterioration in EORTC-QLQ-C30 scores Time Frame: Assessed up to approximately 60 months	Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.	Assessed up to approximately 60 months
Health-related quality of life - EORTC QLQ-BR45 Time Frame: Assessed up to approximately 60 months	Change from baseline in the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR45) score. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.	Assessed up to approximately 60 months

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)

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