Clinical trial NCT05592483: An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: Real-World Evidence
Unresectable Breast Cancer
Metastatic Breast Cancer
HER2+
HER2-low
Observational
non-interventional
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-10-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Real-World Time to Next Treatment (rwTTNT)
timeFrame: From first dose of T-DXd until study discontinuation (approximately 3 years)
measure: T-Dxd treatment patterns for HER2+ cohort
timeFrame: Approximately 3 years
Secondary outcomes:
measure: T-Dxd treatment patterns for HER2-low
timeFrame: Approximately 3 years
measure: Demographics and clinical charcteristics
timeFrame: At Baseline (14 to 30 days prior to T-DXd initiation)
measure: Number of patients with Physician reported Safety Events of Interest (SEIs)
timeFrame: From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)
measure: Number of patients provided prophylactic and reactive treatment for SEIs management
timeFrame: From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)
measure: Real-World Time to Discontinuation (rwTTD)
timeFrame: From first dose of T-DXd until study discontinuation (approximately 3 years)
measure: Patient-reported overall side effect burden as measured by the Patient's Global Impression of Treatment Tolerability (PGI-TT)
timeFrame: Approximately 3 years
measure: 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)
timeFrame: Approximately 3 years
measure: Daily Nausea and Vomiting symptom diary
timeFrame: From first dose of T-DXd until 3 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Chandler
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: Pensacola
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Evergreen Park
country: United States
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state: Illinois
city: Glenview
country: United States
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state: Illinois
city: Park Ridge
country: United States
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state: Illinois
city: Lexington
country: United States
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state: Kentucky
city: Louisville
country: United States
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state: Kentucky
city: Annapolis
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state: Maryland
city: Boston
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state: Massachusetts
city: Southfield
country: United States
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state: Michigan
city: Saint Paul
country: United States
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state: Minnesota
city: Kansas City
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state: Missouri
city: Camden
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state: New Jersey
city: Florham Park
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city: Jamaica
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state: New York
city: Lake Success
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city: Eugene
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state: Oregon
city: York
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state: Pennsylvania
city: Greenville
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city: Germantown
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city: Knoxville
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state: Tennessee
city: Memphis
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city: Nashville
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city: Dallas
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state: Texas
city: Dallas
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state: Texas
city: El Paso
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state: Texas
city: Fort Worth
country: United States
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state: Texas
city: McAllen
country: United States
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state: Texas
city: McKinney
country: United States
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state: Texas
city: San Antonio
country: United States
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city: Tyler
country: United States
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state: Virginia
city: Roanoke
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state: Virginia
city: Everett
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state: Washington
city: Milwaukee
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city: Wien
country: Austria
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state: Nordrhein-Westfalen
city: Wels
country: Austria
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state: Oberosterreich
city: Graz
country: Austria
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state: Steiermark
city: Innsbruck
country: Austria
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state: Tirol
city: Wien
country: Austria
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city: Salvador
country: Brazil
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state: Bahia
city: Brasilia
country: Brazil
facility: Research Site
state: Distrito Federal
city: Cachoeiro de Itapemirim
country: Brazil
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state: Espirito Santo
city: Belo Horizonte
country: Brazil
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state: Minas Gerais
city: Curitiba
country: Brazil
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state: Paran
city: Porto Alegre
country: Brazil
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state: Rio Grande Do Sul
city: Itajai
country: Brazil
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city: Porto Alegre
country: Brazil
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city: Sao Paulo
country: Brazil
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city: Sao Paulo
country: Brazil
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city: Calgary
country: Canada
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state: Alberta
city: Surrey
country: Canada
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state: British Columbia
city: Vancouver
country: Canada
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state: British Columbia
city: Kingston
country: Canada
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state: Ontario
city: Kitchener
country: Canada
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state: Ontario
city: Montreal
country: Canada
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state: Quebec
city: Quebec
country: Canada
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city: Tel Aviv
country: Israel
facility: Research Site
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Research Site
state: Yerushalayim
city: Be Er Sheva
country: Israel
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city: Haifa
country: Israel
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city: Brescia
country: Italy
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city: Brindisi
country: Italy
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city: Catania
country: Italy
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city: Cremona
country: Italy
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city: Palermo
country: Italy
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city: Pisa
country: Italy
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city: Roma
country: Italy
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city: Roma
country: Italy
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city: Torino
country: Italy
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city: Verona
country: Italy
facility: Research Site
city: Coruna
country: Spain
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state: A Coruna
city: Elche
country: Spain
facility: Research Site
state: Alicante
city: Zaragoza
country: Spain
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state: Aragon
city: Oviedo
country: Spain
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state: Asturias
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: L'Hospitalet De Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: Research Site
state: Cadiz
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
state: Canarias
city: Sta. Cruz De Tenerife
country: Spain
facility: Research Site
state: Canarias
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Madrid
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Ourense
country: Spain
facility: Research Site
state: Galicia
city: San Sebastian
country: Spain
facility: Research Site
state: Guipuzcoa
city: Logrono
country: Spain
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state: La Rioja
city: Majadahonda
country: Spain
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state: Madrid
city: Pamplona
country: Spain
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state: Navarra
city: Reus
country: Spain
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state: Tarragona
city: Baracaldo
country: Spain
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state: Vizcaya
city: Barcelona
country: Spain
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city: Barcelona
country: Spain
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city: Barcelona
country: Spain
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city: Barcelona
country: Spain
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city: Burgos
country: Spain
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city: Caceres
country: Spain
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city: Cordoba
country: Spain
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city: Lleida
country: Spain
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city: Madrid
country: Spain
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city: Malaga
country: Spain
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city: Murcia
country: Spain
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city: Segovia
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Liestal
country: Switzerland
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city: Monthey
country: Switzerland
facility: Research Site
city: Keighley
country: United Kingdom
facility: Research Site
state: England
city: Rickmansworth
country: United Kingdom
facility: Research Site
state: England
city: Londonderry
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Inverness
country: United Kingdom
facility: Research Site
state: Scotland
city: Taunton
country: United Kingdom
facility: Research Site
state: Somerset
city: Coventry
country: United Kingdom
facility: Research Site
city: Huddersfield
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
References: