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

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: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: None (Observational Study)

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: Observational
• Enrollment (Actual): 78

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics and clinical charcteristics	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)	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	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)	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)	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)	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	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	Treatment patterns will be summarised using summary statistics.	Approximately 3 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR not created for the study-rationale

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Actual): May 29, 2024
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Observational; Metastatic Breast Cancer; HER2+; non-interventional; Real-World Evidence; HER2-low; Unresectable Breast Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID 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