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NCT05592483Terminated

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

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

Source: ClinicalTrials.gov · Last updated 7 Nov 2024

Reason given: The DESTINY-Breast RESPOND study was terminated early due to start-up delays and slow enrolment, despite extensive mitigation. Operational challenges alone prevent study continuation and were not related to any product or patient safety concerns.

Brief summary (registry, in English)

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 (registry)
Terminated
Study type
Observational
Enrollment
78 (actual)
First submitted
20 Oct 2022
Start date
7 Jul 2023
Primary completion date
29 May 2024
Lead sponsor
AstraZeneca
NCT number
NCT05592483

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of other primary malignancies in 2 years prior to unresectable and/or mBC diagnosis.

Other

  • Pregnancy or breastfeeding.
  • Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (113)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-GrazAustriaUnknown status
-InnsbruckAustriaUnknown status
-ViennaAustriaUnknown status
-WelsAustriaUnknown status
-Belo HorizonteBrazilUnknown status
-BrasíliaBrazilUnknown status
-Cachoeiro de ItapemirimBrazilUnknown status
-CuritibaBrazilUnknown status
-ItajaíBrazilUnknown status
-Porto AlegreBrazilUnknown status
-SalvadorBrazilUnknown status
-São PauloBrazilUnknown status
-CalgaryCanadaUnknown status
-KingstonCanadaUnknown status
-KitchenerCanadaUnknown status
-MontrealCanadaUnknown status
-QuébecCanadaUnknown status
-SurreyCanadaUnknown status
-VancouverCanadaUnknown status
-BaselSwitzerlandUnknown status
-BernSwitzerlandUnknown status
-LiestalSwitzerlandUnknown status
-MontheySwitzerlandUnknown status
-A CoruñaSpainUnknown status
-BarakaldoSpainUnknown status
-BarcelonaSpainUnknown status
-BurgosSpainUnknown status
-CáceresSpainUnknown status
-CórdobaSpainUnknown status
-Donostia / San SebastianSpainUnknown status
-ElcheSpainUnknown status
-Jerez de la FronteraSpainUnknown status
-Las Palmas de Gran CanariaSpainUnknown status
-L'Hospitalet de LlobregatSpainUnknown status
-LleidaSpainUnknown status
-LogroñoSpainUnknown status
-MadridSpainUnknown status
-MajadahondaSpainUnknown status
-MálagaSpainUnknown status
-MurciaSpainUnknown status
-OurenseSpainUnknown status
-OviedoSpainUnknown status
-Palma de MallorcaSpainUnknown status
-PamplonaSpainUnknown status
-ReusSpainUnknown status
-Santa Cruz de TenerifeSpainUnknown status
-SantanderSpainUnknown status
-SegoviaSpainUnknown status
-SevilleSpainUnknown status
-ToledoSpainUnknown status
-ValenciaSpainUnknown status
-ZaragozaSpainUnknown status
-CoventryUnited KingdomUnknown status
-HuddersfieldUnited KingdomUnknown status
-InvernessUnited KingdomUnknown status
-KeighleyUnited KingdomUnknown status
-LeedsUnited KingdomUnknown status
-LondonderryUnited KingdomUnknown status
-ManchesterUnited KingdomUnknown status
-RickmansworthUnited KingdomUnknown status
-TauntonUnited KingdomUnknown status
-BeershebaIsraelUnknown status
-HaifaIsraelUnknown status
-JerusalemIsraelUnknown status
-Tel AvivIsraelUnknown status
-BresciaItalyUnknown status
-BrindisiItalyUnknown status
-CataniaItalyUnknown status
-CremonaItalyUnknown status
-PalermoItalyUnknown status
-PisaItalyUnknown status
-RomaItalyUnknown status
-TorinoItalyUnknown status
-VeronaItalyUnknown status
-AnnapolisUnited StatesUnknown status
-AtlantaUnited StatesUnknown status
-BostonUnited StatesUnknown status
-CamdenUnited StatesUnknown status
-ChandlerUnited StatesUnknown status
-DallasUnited StatesUnknown status
-El PasoUnited StatesUnknown status
-EugeneUnited StatesUnknown status
-EverettUnited StatesUnknown status
-Evergreen ParkUnited StatesUnknown status
-Florham ParkUnited StatesUnknown status
-Fort WorthUnited StatesUnknown status
-GermantownUnited StatesUnknown status
-GlenviewUnited StatesUnknown status
-GreenvilleUnited StatesUnknown status
-JamaicaUnited StatesUnknown status
-Kansas CityUnited StatesUnknown status
-KnoxvilleUnited StatesUnknown status
-Lake SuccessUnited StatesUnknown status
-LexingtonUnited StatesUnknown status
-Little RockUnited StatesUnknown status
-Los AngelesUnited StatesUnknown status
-LouisvilleUnited StatesUnknown status
-McAllenUnited StatesUnknown status
-McKinneyUnited StatesUnknown status
-MemphisUnited StatesUnknown status
-MilwaukeeUnited StatesUnknown status
-MobileUnited StatesUnknown status
-NashvilleUnited StatesUnknown status
-Park RidgeUnited StatesUnknown status
-PensacolaUnited StatesUnknown status
-PortsmouthUnited StatesUnknown status
-RoanokeUnited StatesUnknown status
-Saint PaulUnited StatesUnknown status
-San AntonioUnited StatesUnknown status
-Santa RosaUnited StatesUnknown status
-SouthfieldUnited StatesUnknown status
-TylerUnited StatesUnknown status
-YorkUnited StatesUnknown status

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.