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Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trastuzumab deruxtecan (DS-8201a)
Capecitabine
Eribulin
Gemcitabine
Paclitaxel
Nab-paclitaxel
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Anti-HER2-Antibody Drug Conjugate (ADC), Unresectable or Metastatic, Human epidermal growth factor receptor 2 (HER2)-low, DESTINY - Breast 04

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is the age of majority in their country

  • Has pathologically documented breast cancer that:

    1. Is unresectable or metastatic
    2. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
    3. Is HR-positive or HR-negative
    4. Has progressed on, and would no longer benefit from, endocrine therapy
    5. Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the metastatic setting
    6. Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
  • Has documented radiologic progression (during or after most recent treatment)

  • Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:

    1. assessment of HER2 status
    2. assessment of post-treatment status
  • Has at least 1 protocol-defined measurable lesion
  • Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
  • Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)

Exclusion Criteria:

  • Is ineligible for all options in the physician's choice arm
  • Has breast cancer ever assessed with high-HER2 expression
  • Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
  • Has uncontrolled or significant cardiovascular disease
  • Has spinal cord compression or clinically active central nervous system metastases
  • Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Sites / Locations

  • Ironwood Cancer & Research Centers - Chandler II
  • Banner MD Anderson Cancer Center
  • Cancer Treatment Centers of America at Western Regional Medical Center
  • UCLA School of Medicine
  • Stanford Cancer Institute
  • Cancer Care Associates Medical Group, Inc. TORI
  • University of California at San Francisco (PARENT)
  • Eastern Connecticut Hematology/Oncology Assoc.
  • Christiana Care Health Services, Inc.
  • Sylvester Comprehensive Cancer Center - Deerfield Beach
  • Florida Cancer Specialists (South Region)
  • Memorial Healthcare System MRH Cancer Center
  • Orlando Health, Inc.
  • Moffitt Cancer Center -Tampa
  • Cancer Treatment Centers of America-Georgia
  • University of Chicago Medical Center
  • Cancer Treatment Centers of America
  • Cancer Center of Kansas
  • Touro Infirmary
  • Dana-Farber Cancer Institute
  • Henry Ford Hospital
  • Saint Luke's Hospital of Kansas City
  • Saint Barnabas Medical Center
  • New York University Medical Center
  • Memorial Sloan Kettering Hospital
  • Weill Cornell Medicine Breast Center
  • The Cleveland Clinic Foundation
  • Oregon Health & Science University
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center Health System
  • St Francis Hospital
  • Brig Center for Cancer Care and Survivorship
  • Baptist Cancer Center
  • Tennessee Oncology - Skyline Satellite
  • BloomTrials Clinical Research, LLC
  • The Methodist Hospital Research Institute
  • University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
  • Virginia Cancer Specialists
  • Medizinische Universität Innsbruck
  • Kepler Universitätsklinikum
  • LKH - Universitätsklinikum der PMU Salzburg
  • AKH - Medizinische Universität Wien (4305)
  • Klinikum Wels-Grieskirchen GmbH
  • Institut Jules Bordet
  • Universitair Ziekenhuis Brussel
  • Cliniques Universitaires Saint-Luc
  • UZ Leuven
  • Grand Hôpital de Charleroi
  • CHU UCL Namur
  • Centre Hospitalier Wallonie picarde - Site IMC
  • Tom Baker Cancer Center
  • Toronto Sunnybrook Hospital
  • McGill University - Dept. Oncology Clinical Research Program
  • Anhui Provincial Hospital
  • Cancer Hospital Chinese Academy of Medical Sciences
  • Chinese PLA General Hospital
  • Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
  • Sun Yat-sen Memorial hospital, Sun Yat-sen University
  • Harbin Medical University Cancer Hospital
  • Hubei Cancer Hospital
  • The Affiliated Drum Tower Hospital of Nanjing University
  • The First Hospital of Jilin University
  • Jilin Cancer Hospital
  • Liaoning Cancer Hospital & Institute
  • General Hospital of Ningxia Medical University
  • Linyi Cancer Hospital
  • Shanghai General Hospital
  • Fudan University Shanghai Cancer Center
  • West China Hospital, Sichuan University
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • Zhejiang Cancer Hospital
  • Institut Paoli Calmettes
  • Centre François Baclesse
  • CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
  • CHU Brest - Hôpital Morvan
  • Institut Bergonié
  • Clinique Clementville
  • Institut Régional du Cancer de Montpellier
  • CRLCC Eugene Marquis
  • ICO - Site René Gauducheau
  • Centre Hospitalier Emile Roux
  • ICO - Site Paul Papin
  • Centre Hospitalier Valenciennes
  • Hôpital Saint-Louis - Paris
  • Clinique Victor Hugo - Centre Jean Bernard
  • Institut Sainte Catherine
  • Hôpital d'Instruction des Armees Begin*
  • Institut Gustave Roussy
  • Institut Curie - site de Paris
  • Hopital Tenon
  • Universitaetsklinikum Heidelberg
  • Klinikum der Universitaet Muenchen - Campus Grosshardern
  • General Hospital of Athens "Alexandra"
  • General Oncology Hospital of Kifissia " Agioi Anargyroi"
  • Athens Medical Center
  • University General Hospital of Heraklion
  • University General Hospital of Larissa
  • Bioclinic Thessaloniki
  • Euromedica General Clinic Thessaloniki
  • General Hospital Papageorgiou
  • Interbalkan Hospital of Thessaloniki
  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  • Orszagos Onkologiai Intezet
  • Debreceni Egyetem
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
  • Rambam Health Care Center
  • Shaare Zedek Medical Center
  • Hadassah University Hospital - Ein Kerem
  • Rabin Medical Center-Beilinson Campus
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Ziv Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliera Card. G. Panico
  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
  • Istituto Clinico Humanitas
  • Ospedale Sacro Cuore Don Calabria
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
  • Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario
  • IEO Istituto Europeo di Oncologia
  • Istituto Nazionale Tumori Fondazione G. Pascale
  • Ospedale degli Infermi
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Aichi Cancer Center Hospital
  • National Cancer Center Hospital East
  • NHO Shikoku Cancer Center
  • NHO Kyushu Cancer Center
  • Fukushima Medical University Hospital
  • Hiroshima City Hiroshima Citizens Hospital
  • NHO Hokkaido Cancer Center
  • Hyogo College of Medicine Hospital
  • Hakuaikai Sagara Hospital
  • Tokai University Hospital
  • Kanagawa Cancer Center
  • NHO Osaka National Hospital
  • Kindai University Hospital
  • Saitama Cancer Center
  • Shizuoka Cancer Center
  • Cancer Institute Hospital of JFCR
  • Toranomon Hospital
  • Showa University Hospital
  • Chungbuk National University Hospital
  • National Cancer Center
  • Inha University Hospital
  • Seoul National University Bundang Hospital
  • Ajou University Hospital
  • Kyungpook National University Chilgok Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Severance Hospital, Yonsei University Health System
  • Hospital de Braga
  • Centro Hospitalar do Alto do Ave, EPE
  • Fundação Champalimaud
  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  • Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)
  • Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
  • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
  • Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  • SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement
  • SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
  • ICO l'Hospitalet - Hospital Duran i Reynals
  • Hospital Universitario Donostia
  • Complejo Hospitalario Universitario A Coruña
  • Hospital Universitario de Canarias
  • Hospital de Basurto
  • Hospital del Mar
  • Hospital Quironsalud Barcelona
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic de Barcelona
  • MD Anderson Cancer Centre
  • Hospital Ruber Internacional
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario Clinico San Carlos
  • Hospital Clinico Universitario Virgen de la Victoria
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen del Rocio
  • Instituto Valenciano de Oncologia IVO
  • Hospital General Universitario de Valencia
  • Karolinska universitetssjukhuset - Solna
  • Länssjukhuset Sundsvall-Härnösand
  • Akademiska Sjukhuset
  • Hirslanden Medical Center
  • Universitaetsspital Basel
  • Kantonsspital Graubuenden
  • Centre Hospitalier Universitaire Vaudois
  • Kantonsspital St. Gallen
  • Kantonsspital Winterthur
  • Universitaetsspital Zuerich
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Royal Cornwall Hospital
  • Queen Mary University of London
  • University College London Hospitals
  • Royal Free Hospital
  • Western General Hospital
  • Nottingham University Hospitals City Campus
  • Royal Surrey County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trastuzumab deruxtecan

Physician's Choice

Arm Description

HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a

HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options: Capecitabine Eribulin Gemcitabine Paclitaxel Nab-paclitaxel

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.

Secondary Outcome Measures

Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.
Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.
Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.
Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.
Number of Overall Survival Events (Deaths)
Overall Survival (OS) in All Patients
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.
Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment.
Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment.
Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method.
Duration of Response in Participants With HER2-low Breast Cancer (All Patients)
Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method.

Full Information

First Posted
November 6, 2018
Last Updated
May 25, 2023
Sponsor
Daiichi Sankyo, Inc.
Collaborators
Daiichi Sankyo Co., Ltd., AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03734029
Brief Title
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
Official Title
A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
January 11, 2022 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
Daiichi Sankyo Co., Ltd., AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: Cannot be removed by an operation Has spread to other parts of the body
Detailed Description
This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants. The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Anti-HER2-Antibody Drug Conjugate (ADC), Unresectable or Metastatic, Human epidermal growth factor receptor 2 (HER2)-low, DESTINY - Breast 04

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel model, randomized at a 2:1 ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
557 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trastuzumab deruxtecan
Arm Type
Experimental
Arm Description
HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a
Arm Title
Physician's Choice
Arm Type
Active Comparator
Arm Description
HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options: Capecitabine Eribulin Gemcitabine Paclitaxel Nab-paclitaxel
Intervention Type
Drug
Intervention Name(s)
Trastuzumab deruxtecan (DS-8201a)
Other Intervention Name(s)
DS-8201a
Intervention Description
DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Administered according to label, as one option for Physician's Choice (determined before randomization)
Intervention Type
Drug
Intervention Name(s)
Eribulin
Intervention Description
Administered according to label, as one option for Physician's Choice (determined before randomization)
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Administered according to label, as one option for Physician's Choice (determined before randomization)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Administered according to label, as one option for Physician's Choice (determined before randomization)
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Administered according to label, as one option for Physician's Choice (determined before randomization)
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Description
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.
Time Frame
From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status
Description
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.
Time Frame
From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Title
Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Description
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.
Time Frame
From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Title
Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)
Description
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.
Time Frame
From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Title
Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Description
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.
Time Frame
From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Title
Number of Overall Survival Events (Deaths)
Time Frame
From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Title
Overall Survival (OS) in All Patients
Description
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.
Time Frame
From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Title
Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Description
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment.
Time Frame
From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Title
Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)
Description
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment.
Time Frame
From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Title
Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Description
Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method.
Time Frame
From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
Title
Duration of Response in Participants With HER2-low Breast Cancer (All Patients)
Description
Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method.
Time Frame
From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
Other Pre-specified Outcome Measures:
Title
All-Cause Mortality
Description
All-cause mortality is defined as all anticipated and unanticipated deaths due to any cause, with the number and frequency of such events by arm or comparison group of the clinical study.
Time Frame
From the date of randomization up to the date of death due to any cause, up to approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is the age of majority in their country Has pathologically documented breast cancer that: Is unresectable or metastatic Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) Is HR-positive or HR-negative Has progressed on, and would no longer benefit from, endocrine therapy Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines) Has documented radiologic progression (during or after most recent treatment) Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for: assessment of HER2 status assessment of post-treatment status Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1 Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels) Exclusion Criteria: Is ineligible for all options in the physician's choice arm Has breast cancer ever assessed with high-HER2 expression Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate Has uncontrolled or significant cardiovascular disease Has spinal cord compression or clinically active central nervous system metastases Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer & Research Centers - Chandler II
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234-2165
Country
United States
Facility Name
Cancer Treatment Centers of America at Western Regional Medical Center
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1690
Country
United States
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Cancer Care Associates Medical Group, Inc. TORI
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
University of California at San Francisco (PARENT)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Eastern Connecticut Hematology/Oncology Assoc.
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Christiana Care Health Services, Inc.
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center - Deerfield Beach
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Florida Cancer Specialists (South Region)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Memorial Healthcare System MRH Cancer Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Orlando Health, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Moffitt Cancer Center -Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
Cancer Treatment Centers of America-Georgia
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Cancer Treatment Centers of America
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Touro Infirmary
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065-6007
Country
United States
Facility Name
Weill Cornell Medicine Breast Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center Health System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
St Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Brig Center for Cancer Care and Survivorship
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Baptist Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Tennessee Oncology - Skyline Satellite
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37201
Country
United States
Facility Name
BloomTrials Clinical Research, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Kepler Universitätsklinikum
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
LKH - Universitätsklinikum der PMU Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH - Medizinische Universität Wien (4305)
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Grand Hôpital de Charleroi
City
Loverval
ZIP/Postal Code
6280
Country
Belgium
Facility Name
CHU UCL Namur
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Centre Hospitalier Wallonie picarde - Site IMC
City
Tournai
ZIP/Postal Code
7500
Country
Belgium
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N2
Country
Canada
Facility Name
Toronto Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
McGill University - Dept. Oncology Clinical Research Program
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Sun Yat-sen Memorial hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
The Affiliated Drum Tower Hospital of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
The First Hospital of Jilin University
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
Jilin Cancer Hospital
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276001
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20032
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Institut Paoli Calmettes
City
Marseille cedex 9
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13009
Country
France
Facility Name
Centre François Baclesse
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
City
Plérin
State/Province
Cotes d'Armor
ZIP/Postal Code
22190
Country
France
Facility Name
CHU Brest - Hôpital Morvan
City
Brest Cedex
State/Province
Finistere
ZIP/Postal Code
29609
Country
France
Facility Name
Institut Bergonié
City
Bordeaux cedex
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Clinique Clementville
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34070
Country
France
Facility Name
Institut Régional du Cancer de Montpellier
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Facility Name
CRLCC Eugene Marquis
City
Rennes-cedex
State/Province
Ille Et Vilaine
ZIP/Postal Code
35042
Country
France
Facility Name
ICO - Site René Gauducheau
City
Saint-Herblain
State/Province
Loire Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Hospitalier Emile Roux
City
Le Puy-en-Velay
State/Province
Loiret
ZIP/Postal Code
43012
Country
France
Facility Name
ICO - Site Paul Papin
City
Angers Cedex 2
State/Province
Maine Et Loire
ZIP/Postal Code
49055
Country
France
Facility Name
Centre Hospitalier Valenciennes
City
Valenciennes
State/Province
Nord
ZIP/Postal Code
59322
Country
France
Facility Name
Hôpital Saint-Louis - Paris
City
Paris Cedex 10
State/Province
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Clinique Victor Hugo - Centre Jean Bernard
City
Le Mans Cedex 02
State/Province
Sarthe
ZIP/Postal Code
72015
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon Cedex 9
State/Province
Vaculuse
ZIP/Postal Code
84918
Country
France
Facility Name
Hôpital d'Instruction des Armees Begin*
City
Saint Mande
State/Province
Val De Marne
ZIP/Postal Code
94160
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif cedex
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Institut Curie - site de Paris
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Campus Grosshardern
City
Munich
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
General Hospital of Athens "Alexandra"
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
General Oncology Hospital of Kifissia " Agioi Anargyroi"
City
Athens
ZIP/Postal Code
14564
Country
Greece
Facility Name
Athens Medical Center
City
Athens
ZIP/Postal Code
15125
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Bioclinic Thessaloniki
City
Thessaloníki
ZIP/Postal Code
54622
Country
Greece
Facility Name
Euromedica General Clinic Thessaloniki
City
Thessaloníki
ZIP/Postal Code
54645
Country
Greece
Facility Name
General Hospital Papageorgiou
City
Thessaloníki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Interbalkan Hospital of Thessaloniki
City
Thessaloníki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Rambam Health Care Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin Medical Center-Beilinson Campus
City
Petah tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52363
Country
Israel
Facility Name
Kaplan Medical Center
City
Rechovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Azienda Ospedaliera Card. G. Panico
City
Tricase
State/Province
Lecce
ZIP/Postal Code
73039
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
City
Monza
State/Province
Milano
ZIP/Postal Code
20900
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale Sacro Cuore Don Calabria
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
City
Catania
ZIP/Postal Code
95125
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
IEO Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale degli Infermi
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Aichi-Ken
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba-Ken
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
NHO Shikoku Cancer Center
City
Matsuyama-shi
State/Province
Ehime-Ken
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
NHO Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
State/Province
Fukushima-Ken
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima-shi
State/Province
Hiroshima-Ken
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
NHO Hokkaido Cancer Center
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Nishinomiya-shi
State/Province
Hyogo-Ken
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Hakuaikai Sagara Hospital
City
Kagoshima
State/Province
Kagoshima-Ken
ZIP/Postal Code
892-0833
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa-Ken
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
NHO Osaka National Hospital
City
Osaka-shi
State/Province
Osaka-Fu
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Kindai University Hospital
City
Onohigashi
State/Province
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Cancer Center
City
Kitaadachi-gun
State/Province
Saitama-Ken
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka-Ken
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Cancer Institute Hospital of JFCR
City
Koto-Ku
State/Province
Tokyo-To
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-Ku
State/Province
Tokyo-To
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa-Ku
State/Province
Tokyo-To
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Chungcheongbuk-do
ZIP/Postal Code
361-711
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
State/Province
Gyeonggi-do
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar do Alto do Ave, EPE
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Fundação Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)
City
Matosinhos
ZIP/Postal Code
4464-509
Country
Portugal
Facility Name
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
City
Santa Maria Da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
City
Vila Nova De Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
City
Vila Real
ZIP/Postal Code
5000-508
Country
Portugal
Facility Name
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Donostia
City
San Sebastián
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña
City
A Coruña
State/Province
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
San Cristobal de la Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Quironsalud Barcelona
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
MD Anderson Cancer Centre
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Ruber Internacional
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Instituto Valenciano de Oncologia IVO
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Karolinska universitetssjukhuset - Solna
City
Solna
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Länssjukhuset Sundsvall-Härnösand
City
Sundsvall
ZIP/Postal Code
85186
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Hirslanden Medical Center
City
Aarau
ZIP/Postal Code
5000
Country
Switzerland
Facility Name
Universitaetsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Kantonsspital Graubuenden
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Universitaetsspital Zuerich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Royal Cornwall Hospital
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Queen Mary University of London
City
London
State/Province
Greater London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
State/Province
Greater London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Lothian Region
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Nottingham University Hospitals City Campus
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
35665782
Citation
Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, Tsurutani J, Ueno NT, Prat A, Chae YS, Lee KS, Niikura N, Park YH, Xu B, Wang X, Gil-Gil M, Li W, Pierga JY, Im SA, Moore HCF, Rugo HS, Yerushalmi R, Zagouri F, Gombos A, Kim SB, Liu Q, Luo T, Saura C, Schmid P, Sun T, Gambhire D, Yung L, Wang Y, Singh J, Vitazka P, Meinhardt G, Harbeck N, Cameron DA; DESTINY-Breast04 Trial Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20. doi: 10.1056/NEJMoa2203690. Epub 2022 Jun 5.
Results Reference
result

Learn more about this trial

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

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