Study Stopped
The DESTINY-Breast RESPOND study was terminated early due to start-up delays and slow enrolment, despite extensive mitigation. Operational challenges alone prevent study continuation and were not related to any product or patient safety concerns.
An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
DB RESPOND
A Multi-center, Multi-country Prospective Observational Study of Patients Initiating T-DXd in the First or Second Treatment Line for HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
1 other identifier
observational
78
9 countries
125
Brief Summary
This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) \[globally\] or HER2-low \[North America only\] in routine clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2023
Shorter than P25 for all trials
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2022
CompletedFirst Posted
Study publicly available on registry
October 24, 2022
CompletedStudy Start
First participant enrolled
July 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2024
CompletedNovember 7, 2024
November 1, 2024
11 months
October 20, 2022
November 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Real-World Time to Next Treatment (rwTTNT)
Real-world time to next treatment will be evaluated. rwTTNT is defined as the length of time from date of first T-Dxd administration to the date the patient received an administration of their next systemic treatment regimen or to their date of death if there is a death prior to having another systemic treatment regimen.
From first dose of T-DXd until study discontinuation (approximately 3 years)
T-Dxd treatment patterns for HER2+ cohort
Treatment patterns will be summarised using summary statistics.
Approximately 3 years
Secondary Outcomes (8)
T-Dxd treatment patterns for HER2-low
Approximately 3 years
Demographics and clinical charcteristics
At Baseline (14 to 30 days prior to T-DXd initiation)
Number of patients with Physician reported Safety Events of Interest (SEIs)
From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)
Number of patients provided prophylactic and reactive treatment for SEIs management
From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)
Real-World Time to Discontinuation (rwTTD)
From first dose of T-DXd until study discontinuation (approximately 3 years)
- +3 more secondary outcomes
Study Arms (2)
HER2+ Cohort
Patients with HER2+ unresectable and/or mBC who are prescribed T-DXd and have received a prior anti-HER2 based regimen.
HER2-low cohort
Patients with HER2-low unresectable and/or mBC who are prescribed T-DXd and have received a prior chemotherapy.
Interventions
Not Applicable since observational study
Eligibility Criteria
Patients with HER2+ and HER2-low unresectable and/or mBC who are prescribed T-DXd for 2L or earlier metastatic treatment per standard of care.
You may qualify if:
- Patients ≥18 years of age at time of consent.
- Histological or cytological confirmed diagnosis of unresectable and/or mBC.
- Documented HER2 status via a validated method.
- Adult patients with unresectable or metastatic HER2+ breast cancer who have received a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing therapy.
- Adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
- Decision to newly initiate monotherapy T-DXd per standard of care.
- Capable of providing informed consent and completing questionnaires.
You may not qualify if:
- Pregnancy or breastfeeding.
- History of other primary malignancies in 2 years prior to unresectable and/or mBC diagnosis.
- Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (125)
Research Site
Mobile, Alabama, 36604, United States
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Chandler, Arizona, 85224, United States
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Little Rock, Arkansas, 72205, United States
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Los Angeles, California, 90064, United States
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Santa Rosa, California, 95403, United States
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Pensacola, Florida, 32503, United States
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Atlanta, Georgia, 30318, United States
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Evergreen Park, Illinois, 60805, United States
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Glenview, Illinois, 60026, United States
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Park Ridge, Illinois, 60068, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40202, United States
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Annapolis, Maryland, 21401, United States
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Boston, Massachusetts, 02111, United States
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Southfield, Michigan, 48075, United States
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Saint Paul, Minnesota, 55102-2389, United States
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Kansas City, Missouri, 64111, United States
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Camden, New Jersey, 08103, United States
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Florham Park, New Jersey, 07932, United States
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Jamaica, New York, 11432, United States
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Lake Success, New York, 11042, United States
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Eugene, Oregon, 97401, United States
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York, Pennsylvania, 17403, United States
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Greenville, South Carolina, 29605, United States
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Germantown, Tennessee, 38138-1762, United States
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Knoxville, Tennessee, 37916, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37236, United States
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Dallas, Texas, 75230-6899, United States
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Dallas, Texas, 75246, United States
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El Paso, Texas, 79902, United States
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Fort Worth, Texas, 76104, United States
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McAllen, Texas, 78503, United States
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McKinney, Texas, 75071, United States
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San Antonio, Texas, 78229-3900, United States
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Tyler, Texas, 75702, United States
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Portsmouth, Virginia, 23708, United States
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Roanoke, Virginia, 24014, United States
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Everett, Washington, 98201, United States
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Milwaukee, Wisconsin, 53215-3692, United States
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Vienna, Nordrhein-Westfalen, 42781, Austria
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Graz, Styria, 8036, Austria
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Innsbruck, Tyrol, 6020, Austria
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Wels, Upper Austria, A-4600, Austria
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Vienna, 1010, Austria
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Cachoeiro de Itapemirim, Espírito Santo, 29308-014, Brazil
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Salvador, Estado de Bahia, 40170-110, Brazil
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Brasília, Federal District, 72115-700, Brazil
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Belo Horizonte, Minas Gerais, 30130-100, Brazil
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Curitiba, Paran, 80040-170, Brazil
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Porto Alegre, Rio Grande do Sul, 90619-900, Brazil
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Itajaí, 88301-220, Brazil
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Porto Alegre, 90035-001, Brazil
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São Paulo, 01236030, Brazil
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São Paulo, 06455-010, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Surrey, British Columbia, V3V 1Z2, Canada
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Vancouver, British Columbia, VSZ 4E6, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Québec, G1S 4L8, Canada
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Jerusalem, Jerusalem, 91120, Israel
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Tel Aviv, Tel Aviv, 64239, Israel
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Beersheba, 8410101, Israel
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Haifa, 34362, Israel
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Brescia, 25123, Italy
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Brindisi, 72100, Italy
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Catania, 95126, Italy
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Cremona, 26100, Italy
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Palermo, 90127, Italy
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Pisa, 56126, Italy
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Roma, 00133, Italy
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Roma, 00144, Italy
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Torino, 10126, Italy
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Verona, 37126, Italy
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A Coruña, A Coruna, 15006, Spain
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Elche, Alicante, 03203, Spain
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Zaragoza, Aragon, 50009, Spain
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Palma de Mallorca, Balearic Islands, 07120, Spain
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L'Hospitalet de Llobregat, Barcelona, 08908, Spain
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Jerez de la Frontera, Cadiz, 11407, Spain
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Las Palmas de Gran Canaria, Canary Islands, 35016, Spain
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Santa Cruz de Tenerife, Canary Islands, 38010, Spain
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Santander, Cantabria, 39008, Spain
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Ourense, Galicia, 32005, Spain
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Donostia / San Sebastian, Guipuzcoa, 20014, Spain
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Logroño, La Rioja, 26006, Spain
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Madrid, Madrid, 28040, Spain
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Madrid, Madrid, 28046, Spain
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Majadahonda, Madrid, 28222, Spain
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Pamplona, Navarre, 31008, Spain
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Oviedo, Principality of Asturias, 33011, Spain
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Reus, Tarragona, 43204, Spain
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Barakaldo, Vizcaya, 48903, Spain
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Barcelona, '8036, Spain
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Barcelona, 08003, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Burgos, 09006, Spain
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Cáceres, 10003, Spain
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Córdoba, 14004, Spain
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Lleida, 25198, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Murcia, 30008, Spain
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Segovia, 40002, Spain
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Seville, 41009, Spain
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Toledo, 45004, Spain
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Valencia, 46014, Spain
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Zaragoza, 50012, Spain
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Basel, 4031, Switzerland
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Basel, CH-5405, Switzerland
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Bern, 3010, Switzerland
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Liestal, CH-4410, Switzerland
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Monthey, 1870, Switzerland
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Keighley, England, BD20 6TD, United Kingdom
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Rickmansworth, England, HA6 2RN, United Kingdom
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Londonderry, Northern Ireland, BT47 6SB, United Kingdom
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Inverness, Scotland, IV2 3BW, United Kingdom
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Taunton, Somerset, TA1 5DA, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Huddersfield, HD3 3EA, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2022
First Posted
October 24, 2022
Study Start
July 7, 2023
Primary Completion
May 29, 2024
Study Completion
May 29, 2024
Last Updated
November 7, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.