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

Breast Cancer Clinical Trial

— DB RESPOND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05592483
• Other study ID #: D9673R00025
• Status: Recruiting
• Start date: July 7, 2023
• Est. completion date: October 27, 2026

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 27, 2026
• Est. primary completion date: October 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• None (Observational Study)
Not Applicable since observational study

Locations

Country	Name	City	State
Austria	Research Site	Graz	Steiermark
Austria	Research Site	Innsbruck	Tirol
Austria	Research Site	Wels	Oberösterreich
Austria	Research Site	Wien
Austria	Research Site	Wien	Nordrhein-Westfalen
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Brasilia	Distrito Federal
Brazil	Research Site	Cachoeiro de Itapemirim	Espírito Santo
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Itajai
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Salvador	Bahia
Brazil	Research Site	São Paulo
Brazil	Research Site	São Paulo
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Kitchener	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Surrey	British Columbia
Canada	Research Site	Vancouver	British Columbia
Israel	Research Site	Be'er Sheva
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem	Yerushalayim
Israel	Research Site	Tel Aviv	Tel-Aviv
Italy	Research Site	Brescia
Italy	Research Site	Brindisi
Italy	Research Site	Catania
Italy	Research Site	Cremona
Italy	Research Site	Palermo
Italy	Research Site	Pisa
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Torino
Italy	Research Site	Verona
Spain	Research Site	Baracaldo	Vizcaya
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Burgos
Spain	Research Site	Cáceres
Spain	Research Site	Cordoba	Córdoba
Spain	Research Site	Coruña	A Coruña
Spain	Research Site	Elche	Alicante
Spain	Research Site	Jerez de la Frontera	Cádiz
Spain	Research Site	L'Hospitalet De Llobregat	Barcelona
Spain	Research Site	Las Palmas de Gran Canaria	Canarias
Spain	Research Site	Lleida
Spain	Research Site	Logrono	La Rioja
Spain	Research Site	Madrid
Spain	Research Site	Madrid	Comunidad De Madrid
Spain	Research Site	Madrid	Comunidad De Madrid
Spain	Research Site	Majadahonda	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Murcia
Spain	Research Site	Ourense	Galicia
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Palma de Mallorca	Baleares
Spain	Research Site	Pamplona	Navarra
Spain	Research Site	Reus	Tarragona
Spain	Research Site	San Sebastián	Guipúzcoa
Spain	Research Site	Santander	Cantabria
Spain	Research Site	Segovia
Spain	Research Site	Sevilla
Spain	Research Site	Sta. Cruz De Tenerife	Canarias
Spain	Research Site	Toledo
Spain	Research Site	Valencia
Spain	Research Site	Zaragoza
Spain	Research Site	Zaragoza	Aragón
Switzerland	Research Site	Basel
Switzerland	Research Site	Basel
Switzerland	Research Site	Bern
Switzerland	Research Site	Liestal
Switzerland	Research Site	Monthey
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Huddersfield
United Kingdom	Research Site	Inverness	Scotland
United Kingdom	Research Site	Keighley	England
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Londonderry	Northern Ireland
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Rickmansworth	England
United Kingdom	Research Site	Taunton	Somerset
United States	Research Site	Annapolis	Maryland
United States	Research Site	Atlanta	Georgia
United States	Research Site	Boston	Massachusetts
United States	Research Site	Camden	New Jersey
United States	Research Site	Chandler	Arizona
United States	Research Site	Dallas	Texas
United States	Research Site	El Paso	Texas
United States	Research Site	Eugene	Oregon
United States	Research Site	Everett	Washington
United States	Research Site	Evergreen Park	Illinois
United States	Research Site	Florham Park	New Jersey
United States	Research Site	Fort Worth	Texas
United States	Research Site	Germantown	Tennessee
United States	Research Site	Glenview	Illinois
United States	Research Site	Greenville	South Carolina
United States	Research Site	Jamaica	New York
United States	Research Site	Kansas City	Missouri
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Lake Success	New York
United States	Research Site	Lexington	Kentucky
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	McAllen	Texas
United States	Research Site	McKinney	Texas
United States	Research Site	Memphis	Tennessee
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Mobile	Alabama
United States	Research Site	Nashville	Tennessee
United States	Research Site	Park Ridge	Illinois
United States	Research Site	Pensacola	Florida
United States	Research Site	Portsmouth	Virginia
United States	Research Site	Roanoke	Virginia
United States	Research Site	Saint Paul	Minnesota
United States	Research Site	San Antonio	Texas
United States	Research Site	Santa Rosa	California
United States	Research Site	Southfield	Michigan
United States	Research Site	Tyler	Texas
United States	Research Site	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  Canada,  Israel,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	T-Dxd treatment patterns for HER2+ cohort	Treatment patterns will be summarised using summary statistics.	Approximately 3 years
Secondary	T-Dxd treatment patterns for HER2-low	Treatment patterns will be summarised using summary statistics.	Approximately 3 years
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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