Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

February 21, 2024 updated by: AstraZeneca

Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.

Study Overview

Status

Active, not recruiting

Conditions

Breast Cancer; HER2-positive; Metastatic

Intervention / Treatment

Detailed Description

Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer.

The study aims to evaluate the efficacy, and safety of trastuzumab deruxtecan, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). 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)

1156

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 Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Contact Backup

Name: AZ Breast Cancer Study Navigators
Phone Number: +1-877-400-4656
Email: AstraZeneca@CareboxHealth.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1125ABD
    - Research Site
  - Caba, Argentina, C1012AAR
    - Research Site
  - Caba, Argentina, 1414
    - Research Site
  - Caba, Argentina, C1118AAT
    - Research Site
  - Capital Federal, Argentina, C1417DTB
    - Research Site
  - Cipolletti, Argentina, 8234
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1280
    - 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
  - San Salvador de Jujuy, Argentina, 4600
    - Research Site
Belgium
- - Brussels, Belgium, 1160
    - 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
Brazil
- - Florianópolis, Brazil, 88034-000
    - Research Site
  - Goiânia, Brazil, 74000-000
    - Research Site
  - Londrina, Brazil, 86015-520
    - Research Site
  - Natal, Brazil, 59075-740
    - Research Site
  - Porto Alegre, Brazil, 90035-003
    - Research Site
  - Ribeirão Preto, Brazil, 14015-130
    - Research Site
  - Sorocaba, Brazil, 18030-005
    - Research Site
  - São Paulo, Brazil, 03102-002
    - Research Site
  - Vitoria, Brazil, 29043-260
    - Research Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Research Site
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Research Site
  - Kitchener, Ontario, Canada, N2G 1G3
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 2P9
    - Research Site
  - North York, Ontario, Canada, M2K 1E1
    - Research Site
  - Toronto, Ontario, Canada, M5G 1X5
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - Research Site
  - Montreal, Quebec, Canada, H2X 3E4
    - Research Site
  - Montreal, Quebec, Canada, H1T 2M4
    - Research Site
  - Montreal, Quebec, Canada, H3T 1M5
    - Research Site
  - Ste-Foy, Quebec, Canada, G1V 4G2
    - Research Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Research Site
China
- - Beijing, China, 100044
    - Research Site
  - Beijing, China, 100191
    - Research Site
  - Beijing, China, 100039
    - Research Site
  - Changchun, China, 130021
    - Research Site
  - Changsha, China, 410013
    - Research Site
  - Changsha, China, 410008
    - Research Site
  - Chengdu, China, 610041
    - Research Site
  - Chongqing, China, 400030
    - Research Site
  - Chongqing, China, 400016
    - Research Site
  - Dalian, China, 116011
    - 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
  - Harbin, China, 150049
    - Research Site
  - Kunming, China, 650118
    - Research Site
  - Nanchang, China, 330009
    - Research Site
  - Nanjing, China, 210029
    - Research Site
  - Nanjing, China, 210008
    - Research Site
  - Nanning, China, 530021
    - Research Site
  - Qingdao, China, 266100
    - Research Site
  - Shanghai, China, 200032
    - Research Site
  - Shanghai, China, 200025
    - Research Site
  - Shenyang, China, 110001
    - Research Site
  - Shenzhen, China, 518036
    - Research Site
  - Tianjin, China, 300060
    - Research Site
  - Wu Han, China, 430060
    - Research Site
  - Wuhan, China, 430022
    - Research Site
  - Wuhan, China, 430030
    - Research Site
  - Xi'an, China, 710061
    - Research Site
  - Xi'an, China, 710004
    - Research Site
  - Yinchuan, China, 750004
    - Research Site
  - Zhengzhou, China, 450008
    - Research Site
Denmark
- - Copenhagen O, Denmark, 2100
    - Research Site
  - Sønderborg, Denmark, 6400
    - Research Site
  - Vejle, Denmark, 7100
    - Research Site
France
- - Avignon, France, 84000
    - Research Site
  - Besancon, France, 25000
    - Research Site
  - Bordeaux, France, 33030
    - Research Site
  - Caen Cedex, France, 14076
    - Research Site
  - Le Mans, France, 72000
    - Research Site
  - Montpellier, France, 34298
    - Research Site
  - Montpellier, France, 34070
    - Research Site
  - Nice Cedex 2, France, 06189
    - Research Site
  - Paris, France, 75005
    - Research Site
  - Pierre Benite Cedex, France, 69495
    - Research Site
  - Rennes, France, 35042
    - Research Site
  - Saint Cloud, France, 92210
    - Research Site
  - Saint Herblain, France, 44805
    - Research Site
  - Toulouse Cedex 9, France, 31059
    - Research Site
  - Vandoeuvre les Nancy, France, 54519
    - Research Site
Germany
- - Berlin, Germany, 10117
    - Research Site
  - Dresden, Germany, 1307
    - Research Site
  - Erlangen, Germany, 91054
    - Research Site
  - Essen, Germany, 45136
    - Research Site
  - Frankfurt am Main, Germany, 60431
    - Research Site
  - Freiburg, Germany, 79110
    - Research Site
  - Hamburg, Germany, 20357
    - Research Site
  - Heidelberg, Germany, 69120
    - Research Site
  - Leipzig, Germany, 04103
    - Research Site
  - Muenster, Germany, 48149
    - Research Site
  - Paderborn, Germany, 33161
    - Research Site
Hungary
- - Budapest, Hungary, 1115
    - Research Site
  - Budapest, Hungary, 1145
    - Research Site
  - Budapest, Hungary, 1122
    - Research Site
  - Budapest, Hungary, 1062
    - Research Site
  - Budapest, Hungary, 1082
    - Research Site
  - Győr, Hungary, 9024
    - Research Site
  - Kecskemét, Hungary, 6000
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Research Site
  - Szolnok, Hungary, 5000
    - Research Site
India
- - Ahmedabad, India, 380060
    - Research Site
  - Bangalore, India, 560027
    - Research Site
  - Bengaluru, India, 560099
    - Research Site
  - Calicut, India, 673601
    - Research Site
  - Gurgaon, India, 122001
    - Research Site
  - Mysuru, India, 570017
    - Research Site
  - Nashik, India, 422009
    - Research Site
  - Nashik, India, 422011
    - Research Site
  - New Delhi, India, 110075
    - Research Site
  - New Delhi, India, 110085
    - Research Site
Israel
- - Haifa, Israel, 31096
    - Research Site
  - Jerusalem, Israel, 9112001
    - Research Site
  - Petah Tikva, Israel, 4941492
    - Research Site
  - Ramat Gan, Israel
    - Research Site
  - Tel-Aviv, Israel, 64239
    - Research Site
Italy
- - Bergamo, Italy, 24127
    - Research Site
  - Candiolo, Italy, 10060
    - Research Site
  - Genova, Italy, 16132
    - Research Site
  - Livorno, Italy, 57100
    - Research Site
  - Milan, Italy, 20141
    - Research Site
  - Napoli, Italy, 80131
    - Research Site
  - Padova, Italy, 35128
    - Research Site
  - Rozzano, Italy, 20089
    - Research Site
  - Udine, Italy, 33100
    - Research Site
Japan
- - Akashi-shi, Japan, 673-8558
    - Research Site
  - Aomori-shi, Japan, 030-8553
    - Research Site
  - Bunkyo-ku, Japan, 113-8431
    - Research Site
  - Chiba-shi, Japan, 260-8717
    - Research Site
  - Chuo-ku, Japan, 104-0045
    - Research Site
  - Fukushima-shi, Japan, 960-1295
    - Research Site
  - Hidaka-shi, Japan, 350-1298
    - Research Site
  - Hiroshima-shi, Japan, 730-8518
    - Research Site
  - Hiroshima-shi, Japan, 734-8551
    - Research Site
  - Isehara-shi, Japan, 259-1193
    - Research Site
  - Kagoshima-shi, Japan, 892-0833
    - Research Site
  - Kawasaki-shi, Japan, 216-8511
    - Research Site
  - Kobe-shi, Japan, 650-0047
    - Research Site
  - Koto-ku, Japan, 135-8550
    - Research Site
  - Kurume-shi, Japan, 830-0011
    - Research Site
  - Kyoto-shi, Japan, 606-8507
    - Research Site
  - Matsuyama-shi, Japan, 791-0280
    - Research Site
  - Nagoya-shi, Japan, 464-8681
    - Research Site
  - Nagoya-shi, Japan, 467-0001
    - Research Site
  - Niigata-shi, Japan, 951-8566
    - Research Site
  - Nishinomiya-shi, Japan, 663-8501
    - Research Site
  - Okayama, Japan, 700-8558
    - Research Site
  - Osaka-shi, Japan, 541-8567
    - Research Site
  - Ota-shi, Japan, 373-8550
    - Research Site
  - Sapporo-shi, Japan, 003-0804
    - Research Site
  - Sendai-shi, Japan, 980-8574
    - Research Site
  - Shinagawa-ku, Japan, 142-8666
    - Research Site
  - Shinjuku-ku, Japan, 162-8655
    - 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
- - Cheonan-si, Korea, Republic of, 31151
    - Research Site
  - Daegu, Korea, Republic of, 41404
    - Research Site
  - Goyang-si, Korea, Republic of, 10408
    - 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, 06273
    - Research Site
  - Seoul, Korea, Republic of, 06351
    - Research Site
  - Seoul, Korea, Republic of, 06591
    - Research Site
  - Seoul, Korea, Republic of, 08308
    - Research Site
Mexico
- - Alc. Cuauhtémoc, Mexico, 06700
    - Research Site
  - Estado de México, Mexico, 50080
    - Research Site
  - Guadalajara, Mexico, 44680
    - Research Site
  - Metepec, Mexico, 52140
    - Research Site
  - Nuevo Leon, Mexico, 66278
    - Research Site
  - Veracruz, Mexico, 91910
    - Research Site
Peru
- - Arequipa, Peru, AREQUIPA01
    - Research Site
  - Lima, Peru, 15033
    - Research Site
  - Lima, Peru, LIMA 34
    - Research Site
  - Lima, Peru, LIMA 29
    - Research Site
  - Lima, Peru, 15036
    - Research Site
Philippines
- - Baguio City, Philippines, 2600
    - Research Site
  - Cebu City, Philippines, 6000
    - Research Site
  - Davao City, Philippines, 8000
    - Research Site
  - Iloilo City, Philippines, 5000
    - Research Site
  - Manila, Philippines, 1000
    - Research Site
  - Quezon City, Philippines, 1112
    - Research Site
  - San Juan, Philippines, 1500
    - Research Site
Romania
- - Bucharest, Romania, 011461
    - Research Site
  - Floresti, Romania, 407280
    - Research Site
  - Timisoara, Romania, 300239
    - Research Site
Russian Federation
- - Moscow, Russian Federation, 129090
    - Research Site
  - Moscow, Russian Federation, 121205
    - Research Site
  - Moscow, Russian Federation, 143442
    - Research Site
  - Saint Petersburg, Russian Federation, 197758
    - Research Site
  - Saint Petersburg, Russian Federation, 190020
    - Research Site
  - Yaroslavl, Russian Federation, 150054
    - Research Site
Saudi Arabia
- - Dammam, Saudi Arabia, 31444
    - Research Site
  - Jeddah, Saudi Arabia, 22384
    - Research Site
  - Jeddah, Saudi Arabia, 23214
    - Research Site
  - Riyadh, Saudi Arabia, 11426
    - Research Site
  - Riyadh, Saudi Arabia, 11525
    - Research Site
  - Riyadh, Saudi Arabia, 11211
    - Research Site
South Africa
- - Cape Town, South Africa, 7570
    - Research Site
  - Cape Town, South Africa, 7925
    - Research Site
  - George, South Africa, 6529
    - Research Site
  - Johannesburg, South Africa, 2196
    - Research Site
  - Parktown, South Africa, 2193
    - Research Site
  - Port Elizabeth, South Africa, 6045
    - Research Site
  - Pretoria, South Africa, 0081
    - Research Site
  - Rondebosch, South Africa, 7700
    - Research Site
  - Soweto, South Africa, 2013
    - Research Site
Spain
- - Alicante, Spain, 03010
    - Research Site
  - Barcelona, Spain, 08036
    - Research Site
  - Barcelona, Spain, 8035
    - Research Site
  - Barcelona, Spain, 08028
    - Research Site
  - Madrid, Spain, 28046
    - Research Site
  - Madrid, Spain, 28041
    - Research Site
  - Majadahonda, Spain, 28222
    - Research Site
  - Sevilla, Spain, 41009
    - Research Site
Sweden
- - Göteborg, Sweden, 413 45
    - Research Site
  - Stockholm, Sweden, 118 83
    - Research Site
  - Uppsala, Sweden, 75185
    - Research Site
  - Växjö, Sweden, 35185
    - Research Site
  - Örebro, Sweden, 701 85
    - Research Site
Taiwan
- - Taichung, Taiwan, 40443
    - Research Site
  - Tainan, Taiwan, 70403
    - Research Site
  - Taipei, Taiwan, 100
    - Research Site
  - Taipei, Taiwan, 235
    - Research Site
  - Taipei, Taiwan, 10449
    - Research Site
  - Taipei, Taiwan, 11217
    - Research Site
  - Taoyuan, Taiwan, 333
    - Research Site
Turkey
- - Adana, Turkey, 01330
    - Research Site
  - Ankara, Turkey
    - Research Site
  - Ankara, Turkey, 06520
    - Research Site
  - Karsiyaka, Turkey, 35575
    - Research Site
  - Malatya, Turkey, 44280
    - Research Site
  - Samsun, Turkey
    - Research Site
United Kingdom
- - Buckhurst Hill, United Kingdom, IG9 5HX
    - Research Site
  - Edinburgh, United Kingdom, EH4 2XU
    - Research Site
  - Guildford, United Kingdom, GU2 7WG
    - Research Site
  - London, United Kingdom, NW1 2PG
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Research Site
  - Swansea, United Kingdom, SA2 8QA
    - Research Site
  - Taunton, United Kingdom, TA1 5DA
    - Research Site
United States
- Arizona
  - Tucson, Arizona, United States, 85711
    - Research Site
- Arkansas
  - Springdale, Arkansas, United States, 72762
    - Research Site
- California
  - Glendale, California, United States, 91206
    - Research Site
  - Glendale, California, United States, 91204
    - Research Site
- Colorado
  - Longmont, Colorado, United States, 80501
    - Research Site
- Florida
  - Miami, Florida, United States, 33176
    - Research Site
  - Palm Bay, Florida, United States, 32909
    - Research Site
  - Plantation, Florida, United States, 33324
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30318
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40241
    - Research Site
- Maryland
  - Silver Spring, Maryland, United States, 20904
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Research Site
- Mississippi
  - Jackson, Mississippi, United States, 39213
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89128
    - Research Site
- New Jersey
  - Summit, New Jersey, United States, 07901
    - Research Site
- New York
  - New York, New York, United States, 10065
    - Research Site
  - Shirley, New York, United States, 11967
    - Research Site
- Pennsylvania
  - York, Pennsylvania, United States, 17403
    - Research Site
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Research Site
- Texas
  - Dallas, Texas, United States, 75246
    - Research Site
  - Dallas, Texas, United States, 75203
    - Research Site
  - Denton, Texas, United States, 76201
    - Research Site
  - Houston, Texas, United States, 77090
    - Research Site
  - San Antonio, Texas, United States, 78240
    - Research Site
  - Shenandoah, Texas, United States, 77380
    - Research Site
  - Tyler, Texas, United States, 75702
    - Research Site
- Virginia
  - Norfolk, Virginia, United States, 23502
    - Research Site
  - Roanoke, Virginia, United States, 24014
    - Research Site
- Washington
  - Tacoma, Washington, United States, 98405
    - 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 130 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. is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+)
3. is documented by local testing as hormone receptor (HR)-positive or HR-negative disease in the metastatic setting
No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if > 6 months from treatment to metastatic diagnosis.
Has protocol-defined adequate organ and bone marrow function
ECOG performance status 0 or 1

Key Exclusion Criteria:

Ineligible for any of the agents on the study.
Any substance abuse or other medical conditions that, in the investigator's opinion, may interfere with subject's participation or study results
Patients with spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases or treated brain metastases that are no longer symptomatic may be included in the study.
Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment

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: Arm A Trastuzumab deruxtecan (T-DXd) plus pertuzumab-matching placebo	Drug: Trastuzumab deruxtecan Administered by intravenous infusion Other Names: DS-8201a; T-DXd Drug: Placebo Administered by intravenous infusion
Experimental: Arm B Trastuzumab deruxtecan (T-DXd) plus pertuzumab	Drug: Trastuzumab deruxtecan Administered by intravenous infusion Other Names: DS-8201a; T-DXd Drug: Pertuzumab Administered by intravenous infusion
Active Comparator: Arm C Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)	Drug: Pertuzumab Administered by intravenous infusion Drug: Taxane Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion Drug: Trastuzumab Administered by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment Time Frame: Until progression or death, assessed up to approximately 60 months	Defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.	Until progression or death, assessed up to approximately 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) by Investigator assessment Time Frame: Until progression or death, assessed up to approximately 60 months	Defined as time from date of randomisation until the date of objective radiological disease progression according to Investigator using RECIST 1.1 or death by any cause.	Until progression or death, assessed up to approximately 60 months
Overall Survival (OS) Time Frame: Until death, assessed up to approximately 104 months	OS is defined as the time from randomisation until the date of death due to any cause.	Until death, assessed up to approximately 104 months
Objective Response Rate (ORR) by BICR and Investigator assessment Time Frame: Until progression or death (in the absence of progression), assessed up to approximately 60 months	ORR is defined as The proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.	Until progression or death (in the absence of progression), assessed up to approximately 60 months
Duration of Response (DoR) by BICR and Investigator Assessment Time Frame: Until progression or death (in the absence of progression), assessed up to approximately 60 months	DoR is defined as the time from date of first detection of objective response until the date of objective radiological disease progression according to BICR and investigator assessment using RECIST 1.1 or death in the absence of progression.	Until progression or death (in the absence of progression), assessed up to approximately 60 months
Time to second progression or death (PFS2) by Investigator assessment Time Frame: Assessed up to approximately 104 months	PFS2 is defined as the time from randomisation until the date of tumor progression on next-line treatment (the earliest of the progression event subsequent to first subsequent anticancer therapy after the first progression) or death from any cause; second progression will be defined according to local standard clinical practice.	Assessed up to approximately 104 months
To assess the effect of T-DXd ± pertuzumab relative to THP in terms of patient-reported pain in participants with HER2 positive, first-line mBC'. Time Frame: Assessed up to approximately 60 months	Pain progression: Time to sustained deterioration of European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Pain Scale. Scores range from 0-100 based on 2 items with responses ranging from 1-4. A lower score would mean better outcome.	Assessed up to approximately 60 months
To assess patient-reported treatment tolerability Time Frame: Assessed up to approximately 60 months	Proportion of participants experiencing treatment related symptoms as measured by selected items from the European Organisation for Research and Treatment of Cancer, general cancer module (EORTC QLQ-C30), score of 1-4. A lower score would mean better outcome.	Assessed up to approximately 60 months
To assess patient-reported treatment tolerability Time Frame: Assessed up to approximately 60 months	Proportion of patients reporting different levels of overall tolerability as measured by the Patient Global Impression of Treatment Tolerability (PGI-TT), score of 0-4. A lower score would mean a better outcome.	Assessed up to approximately 60 months
To assess patient-reported treatment tolerability Time Frame: Assessed up to approximately 60 months	Proportion of participants experiencing treatment related symptoms as measured by selected items from the European Organisation for Research and Treatment of Cancer, breast cancer module (EORTC QLQ-BR45), score of 1-4. A lower score would mean better outcome.	Assessed up to approximately 60 months
To assess patient-reported treatment tolerability Time Frame: Assessed up to approximately 60 months	Proportion of participants experiencing treatment related symptoms as measured by selected items from the Patient-Reported Outcomes- Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present). A lower score would mean a better outcome.	Assessed up to approximately 60 months
To assess patient-reported treatment tolerability Time Frame: Assessed up to approximately 60 months	The proportion of participants with maintained or improved physical function while on treatment, based on the EORTC QLQ-C30 Physical Functioning scale. Scores range from 0-100, based on 5 items with responses ranging from 1-4. A higher score would mean a better outcome.	Assessed up to approximately 60 months
Serum concentration of trastuzumab deruxtecan and pertuzumab Time Frame: Up to Cycle 6, approximately Week 18; each cycle is 21 days	Determination of trastuzumab deruxtecan and pertuzumab concentrations in serum.	Up to Cycle 6, approximately Week 18; each cycle is 21 days
Immunogenicity of trastuzumab deruxtecan. Time Frame: Up to follow-up period, approximately 60 months	Number and percentage of participants who develop anti-drug antibody (ADA) for trastuzumab deruxtecan.	Up to follow-up period, approximately 60 months
Safety and tolerability of trastuzumab deruxtecan, alone or with pertuzumab Time Frame: Assessed up to approximately 60 months	Number of AEs according to NCI-CTCAE Version 5.0 per each treatment arm	Assessed up to approximately 60 months

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo

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)

April 26, 2021

Primary Completion (Estimated)

March 28, 2025

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Breast Neoplasms; Breast Diseases; Trastuzumab; Antineoplastic Agents, Phytogenic; Anti-drug conjugate; Molecular Mechanisms of Pharmacological Action;

Additional Relevant MeSH Terms

Other Study ID Numbers

D967UC00001
2020-004074-21 (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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Ovarian Cancer | Metastatic Cancer | Metastatic Breast Cancer | Bladder Cancer | Triple Negative Breast Cancer | HER2-positive Breast Cancer | Gastroesophageal Adenocarcinoma | Ovarian Carcinoma | HER2-positive Gastric Cancer | Metastatic Gastrointestinal Carcinoid Tumor | HER2-positive Metastatic Breast... and other conditions

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Breast Cancer | Metastatic Breast Cancer | Estrogen Receptor Positive | Triple Negative | HER2 | HER2 Positive | MBC | ER

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HER2-positive Metastatic Breast Cancer

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Breast Cancer; HER2-positive; Metastatic

Clinical Trials on Trastuzumab deruxtecan

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