Breast Cancer Clinical Trial
— DB RESPONDOfficial 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
NCT number | NCT05592483 |
Other study ID # | D9673R00025 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 7, 2023 |
Est. completion date | October 27, 2026 |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Austria, Brazil, Canada, Israel, Italy, Spain, Switzerland, United Kingdom,
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 |
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