An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer (DB RESPOND)

November 6, 2024 updated by: AstraZeneca

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multi-center, observational prospective study that will characterize the demographic and clinical characteristics, treatment patterns, effectiveness, tolerability and its management, and patient experience of Trastuzumab Deruxtecan (T-DXd) in a real-world setting. This study is planned to be conducted in several countries and aims to enroll approximately 750 patients eligible patients with HER2+ unresectable and/or metastatic breast cancer (mBC) who has received a prior anti HER2 based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and has developed disease recurrence during or within 6 months of completing therapy. Approximately 250 eligible patients with HER2-low unresectable and/or mBC who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy will be enrolled into the study in North America only.

The planned duration of patient recruitment is approximately 18 months for HER2+ and approximately 12 months for HER2 low.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Wien, Austria, 1010
        • Research Site
    • Nordrhein-Westfalen
      • Wien, Nordrhein-Westfalen, Austria, 42781
        • Research Site
    • Oberosterreich
      • Wels, Oberosterreich, Austria, A-4600
        • Research Site
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Research Site
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Research Site
  • Brazil
      • Itajai, Brazil, 88301-220
        • Research Site
      • Porto Alegre, Brazil, 90035-001
        • Research Site
      • Sao Paulo, Brazil, 01236030
        • Research Site
      • Sao Paulo, Brazil, 06455-010
        • Research Site
    • Bahia
      • Salvador, Bahia, Brazil, 40170-110
        • Research Site
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 72115-700
        • Research Site
    • Espirito Santo
      • Cachoeiro de Itapemirim, Espirito Santo, Brazil, 29308-014
        • Research Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Research Site
    • Paran
      • Curitiba, Paran, Brazil, 80040-170
        • Research Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90619-900
        • Research Site
  • Canada
      • Quebec, Canada, G1S 4L8
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Research Site
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Research Site
      • Vancouver, British Columbia, Canada, VSZ 4E6
        • Research Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Research Site
      • Kitchener, Ontario, Canada, N2G 1G3
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Research Site
  • Israel
      • Be Er Sheva, Israel, 8410101
        • Research Site
      • Haifa, Israel, 34362
        • Research Site
    • Tel-Aviv
      • Tel Aviv, Tel-Aviv, Israel, 64239
        • Research Site
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91120
        • Research Site
  • Italy
      • Brescia, Italy, 25123
        • Research Site
      • Brindisi, Italy, 72100
        • Research Site
      • Catania, Italy, 95126
        • Research Site
      • Cremona, Italy, 26100
        • Research Site
      • Palermo, Italy, 90127
        • Research Site
      • Pisa, Italy, 56126
        • Research Site
      • Roma, Italy, 00144
        • Research Site
      • Roma, Italy, 00133
        • Research Site
      • Torino, Italy, 10126
        • Research Site
      • Verona, Italy, 37126
        • Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08036
        • Research Site
      • Barcelona, Spain, 08003
        • Research Site
      • Barcelona, Spain, '8036
        • Research Site
      • Burgos, Spain, 09006
        • Research Site
      • Caceres, Spain, 10003
        • Research Site
      • Cordoba, Spain, 14004
        • Research Site
      • Lleida, Spain, 25198
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Malaga, Spain, 29010
        • Research Site
      • Murcia, Spain, 30008
        • Research Site
      • Segovia, Spain, 40002
        • Research Site
      • Sevilla, Spain, 41009
        • Research Site
      • Toledo, Spain, 45004
        • Research Site
      • Valencia, Spain, 46014
        • Research Site
      • Zaragoza, Spain, 50012
        • Research Site
    • A Coruna
      • Coruna, A Coruna, Spain, 15006
        • Research Site
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Research Site
    • Aragon
      • Zaragoza, Aragon, Spain, 50009
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Research Site
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07120
        • Research Site
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Research Site
    • Cadiz
      • Jerez de la Frontera, Cadiz, Spain, 11407
        • Research Site
    • Canarias
      • Las Palmas de Gran Canaria, Canarias, Spain, 35016
        • Research Site
      • Sta. Cruz De Tenerife, Canarias, Spain, 38010
        • Research Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Research Site
    • Comunidad De Madrid
      • Madrid, Comunidad De Madrid, Spain, 28040
        • Research Site
      • Madrid, Comunidad De Madrid, Spain, 28046
        • Research Site
    • Galicia
      • Ourense, Galicia, Spain, 32005
        • Research Site
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20014
        • Research Site
    • La Rioja
      • Logrono, La Rioja, Spain, 26006
        • Research Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Research Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Research Site
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Research Site
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Research Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Research Site
      • Basel, Switzerland, CH-5405
        • Research Site
      • Bern, Switzerland, 3010
        • Research Site
      • Liestal, Switzerland, CH-4410
        • Research Site
      • Monthey, Switzerland, 1870
        • Research Site
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • Research Site
      • Huddersfield, United Kingdom, HD3 3EA
        • Research Site
      • Leeds, United Kingdom, LS9 7TF
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
    • England
      • Keighley, England, United Kingdom, BD20 6TD
        • Research Site
      • Rickmansworth, England, United Kingdom, HA6 2RN
        • Research Site
    • Northern Ireland
      • Londonderry, Northern Ireland, United Kingdom, BT47 6SB
        • Research Site
    • Scotland
      • Inverness, Scotland, United Kingdom, IV2 3BW
        • Research Site
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Research Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Los Angeles, California, United States, 90064
        • Research Site
      • Santa Rosa, California, United States, 95403
        • Research Site
    • Florida
      • Pensacola, Florida, United States, 32503
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Research Site
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Research Site
      • Glenview, Illinois, United States, 60026
        • Research Site
      • Park Ridge, Illinois, United States, 60068
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Research Site
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Research Site
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Research Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102-2389
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Research Site
      • Florham Park, New Jersey, United States, 07932
        • Research Site
    • New York
      • Jamaica, New York, United States, 11432
        • Research Site
      • Lake Success, New York, United States, 11042
        • Research Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Research Site
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Research Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138-1762
        • Research Site
      • Knoxville, Tennessee, United States, 37916
        • Research Site
      • Memphis, Tennessee, United States, 38120
        • Research Site
      • Nashville, Tennessee, United States, 37236
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Research Site
      • Dallas, Texas, United States, 75230-6899
        • Research Site
      • El Paso, Texas, United States, 79902
        • Research Site
      • Fort Worth, Texas, United States, 76104
        • Research Site
      • McAllen, Texas, United States, 78503
        • Research Site
      • McKinney, Texas, United States, 75071
        • Research Site
      • San Antonio, Texas, United States, 78229-3900
        • Research Site
      • Tyler, Texas, United States, 75702
        • Research Site
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Research Site
      • Roanoke, Virginia, United States, 24014
        • Research Site
    • Washington
      • Everett, Washington, United States, 98201
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215-3692
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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.

Or

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.

Exclusion Criteria:

  • 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.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HER2+ Cohort
Patients with HER2+ unresectable and/or mBC who are prescribed T-DXd and have received a prior anti-HER2 based regimen.
Other: None (Observational Study)
Not Applicable since observational study
Other Names:
  • Observational study
HER2-low cohort
Patients with HER2-low unresectable and/or mBC who are prescribed T-DXd and have received a prior chemotherapy.
Other: None (Observational Study)
Not Applicable since observational study
Other Names:
  • Observational study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Real-World Time to Next Treatment (rwTTNT)
Time Frame: From first dose of T-DXd until study discontinuation (approximately 3 years)
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
Time Frame: Approximately 3 years
Treatment patterns will be summarised using summary statistics.
Approximately 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographics and clinical charcteristics
Time Frame: At Baseline (14 to 30 days prior to T-DXd initiation)
Summary statistics will be used to describe the Demographics and clinical characteristics
At Baseline (14 to 30 days prior to T-DXd initiation)
Number of patients with Physician reported Safety Events of Interest (SEIs)
Time Frame: From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)
The safety and tolerability of T-Dxd through the collection of physician-reported SEIs will be assessed.
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
Time Frame: From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)
The management of SEIs will be characterized.
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)
Time Frame: From first dose of T-DXd until study discontinuation (approximately 3 years)
Real-World Time to Discontinuation of T-DXd will be evaluated. rwTTD is defined as time from index date to the earliest date of T-DXd discontinuation, or death.
From first dose of T-DXd until study discontinuation (approximately 3 years)
Patient-reported overall side effect burden as measured by the Patient's Global Impression of Treatment Tolerability (PGI-TT)
Time Frame: Approximately 3 years
Patient-reported tolerability will be evaluated by PGI-TT. Single question asking patients how bothered they were by the side effects of their cancer treatment, ranging from Not at all to Very much.
Approximately 3 years
Symptomatic SEI as measured by selected items from National Cancer Institute Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
Time Frame: Approximately 3 years
Patient-reported tolerability will be evaluated by selected items from the NCI PRO-CTCAE. The following items are selected: nausea, vomiting, bloating of the abdomen, shortness of breath, cough, heart palpitations, hair loss, and fatigue, tiredness or lack of energy.
Approximately 3 years
Daily Nausea and Vomiting symptom diary
Time Frame: From first dose of T-DXd until 3 months
Nausea and vomiting symptoms diary will be assessed based on severity, interference with appetite and usual activities.
From first dose of T-DXd until 3 months
T-Dxd treatment patterns for HER2-low
Time Frame: Approximately 3 years
Treatment patterns will be summarised using summary statistics.
Approximately 3 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D9673R00025

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 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.

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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