PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan

Breast Cancer Clinical Trial

— PROVIDENCE  

Official title:

Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573893
• Other study ID #: D9673R00028
• Status: Recruiting
• Start date: September 12, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: June 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 is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic breast cancer (BC) and in patients with documented HER2-low unresectable or metastatic BC receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).

Description:

Eligible participants will be those patients with documented HER2-positive unresectable or metastatic BC receiving T-DXd for 2L treatment or patients with documented HER2-low unresectable or metastatic BC receiving T DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice.

All diagnostic and treatment procedures including visit frequency are at the discretion of the treating physician and not defined by the protocol. T-DXd treatment is considered as a selection criteria. Patients will be informed about use of digital healthcare application (DiGA).

Approximately 800 eligible participants will be enrolled which includes 400 patients in the HER2-positive cohort and 400 patients in the HER2-low cohort.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Adults = 18 years old

• Patients with pathologically documented breast cancer that:

• is unresectable or metastatic

• has confirmed HER2+ or HER2-low tumor status by local pathology

• was previously treated with one anti-HER2 directed therapy if the tumor is HER2+ or

• was previously treated with prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy if the tumor is HER2- low.

• Has documented radiologic progression (during or after most recent treatment)

• Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd as second line treatment if the tumor is HER2+ or scheduled for T-DXd treatment if the tumor is HER2 low*

• Patient is able to read and understand either German or English

• Signed written informed consent *The prescription of the medicinal products are clearly separated from the decision to include the patient in this NIS.

Exclusion Criteria:

• Known hypersensitivity to T-DXd or any of the excipients of the drug

• Pregnancy or breast feeding

• Current or planned participation in an interventional clinical trial

• Current or planned systemic treatment of any tumor other than unresectable or metastatic BC

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms

Locations

Country	Name	City	State
Germany	Research Site	Amberg
Germany	Research Site	Ansbach
Germany	Research Site	Aschaffenburg
Germany	Research Site	Augsburg
Germany	Research Site	Bad Reichenhall
Germany	Research Site	Baden-Baden
Germany	Research Site	Beremerhaven
Germany	Research Site	Berlin
Germany	Research Site	Bielefeld
Germany	Research Site	Bonn
Germany	Research Site	Brandenburg an der Havel
Germany	Research Site	Braunschweig
Germany	Research Site	Bremen
Germany	Research Site	Donauwoerth
Germany	Research Site	Dortmund
Germany	Research Site	Eggenfelden
Germany	Research Site	Erfurt
Germany	Research Site	Essen
Germany	Research Site	Filderstadt - Bonlanden
Germany	Research Site	Freudenstadt
Germany	Research Site	Fuerstenwalde
Germany	Research Site	Gerlingen
Germany	Research Site	Giessen
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Hannover
Germany	Research Site	Heidenheim
Germany	Research Site	Heilbronn
Germany	Research Site	Hildesheim
Germany	Research Site	Homburg/Saar
Germany	Research Site	Karlsruhe
Germany	Research Site	Kassel
Germany	Research Site	Kiel
Germany	Research Site	Kulmbach
Germany	Research Site	Landshut
Germany	Research Site	Leer
Germany	Research Site	Leipzig
Germany	Research Site	Loerrach
Germany	Research Site	Lüneburg
Germany	Research Site	Magdeburg
Germany	Research Site	Mainz
Germany	Research Site	Moenchengladbach
Germany	Research Site	Mühlhausen
Germany	Research Site	Mutlangen
Germany	Research Site	Neumarkt
Germany	Research Site	Oldenburg
Germany	Research Site	Oranienburg
Germany	Research Site	Potsdam
Germany	Research Site	Regensburg
Germany	Research Site	Rosenheim
Germany	Research Site	Rotenburg (Wuemme)
Germany	Research Site	Schwaebisch-Hall
Germany	Research Site	Singen
Germany	Research Site	Solingen
Germany	Research Site	Stuttgart
Germany	Research Site	Torgau
Germany	Research Site	Troisdorf
Germany	Research Site	Ulm
Germany	Research Site	Weinheim
Germany	Research Site	Westerstede
Germany	Research Site	Wiesbaden
Germany	Research Site	Winnenden
Germany	Research Site	Zittau

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Daiichi Sankyo

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in HRQoL based on FACT-B questionnaire compared to baseline over time	Defined as changes in FACT-B (total score and subscale domains) at different timepoints compared to baseline. The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQoL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS).	Patient questionnaires will be collected at time points synchronised with clinic visits during study, assessed up to 60 months
Other	Change in HRQoL based on EQ-5D questionnaire compared to baseline over time	Defined as changes in EQ-5D (subscale domains and VAS) at different timepoints compared to baseline.; EQ-5D is a standardized instrument for use as a measure of patient-reported health outcomes (Euro-QoL). The 5 health-state dimensions in the EQ-5D-5L include: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-point scale from 1 (no problem) to 5 (unable to/extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale (EQ VAS) on which the participant rates his or her general state of health at the time of the assessment.	Patient questionnaires will be collected at time points synchronised with clinic visits during study, assessed up to 60 months
Other	Real-world Overall Response Rate (rwORR)	rwORR is defined as percentage of patients having complete response or partial response as best response as determined by the investigator	From first dose of T-DXd until end of T-DXd treatment or death of any cause, whichever came first (investigator-assessed according to clinical routine), assessed up to 60 months
Other	Real-world Progression-free Survival (rwPFS)	rwPFS is defined as time from T-DXd initiation to the date of the first source evidence for progression referenced by the clinician (e. g., radiology/ pathology report date) or the date of clinician note when no other corresponding evidence sources were documented) or death, whichever occurs first	From first dose of T-DXd until disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 60 months
Other	Real-world Overall Survival (rwOS)	rwOS is defined as time from T-DXd initiation to date of death	From first dose of T-DXd until death of any cause, assessed up to 60 months
Other	Real-world Time To Treatment Discontinuation (rwTTD)	rwTTD is defined as time from T-DXd initiation to discontinuation, or death	From first dose of T-DXd until discontinuation of T-DXd treatment therapy or death of any cause, whichever came first, assessed up to 60 months
Other	Real-world Time To Next Treatment 2	rwTTNT2 is defined as time from initiation of T-DXd treatment to initiation of second next treatment, or death	From first dose of T-DXd until initiation of second subsequent therapy or death of any cause, whichever came first, assessed up to 60 months
Other	Real-world Time to Treament Discontinuation 2 (rwTTD2)	rwTTD2 is defined as time from initiation T-DXd treatment to discontinuation of corresponding subsequent therapy, or death	From first dose of T-DXd until discontinuation of corresponding subsequent therapy or death of any cause, whichever came first, assessed up to 60 months
Other	Real-world Progression-free Survival (rwPFS2)	rwPFS2 is defined as time from T-DXd initiation to the date of the first source evidence for the second progression referenced by the clinician (e. g., radiology/ pathology report date) or the date of clinician note when no other corresponding evidence sources were documented) or death, whichever occurs first	From first dose of T-DXd until second disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 60 months
Other	Safety: Collection of Adverse Events (AE)	Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness	during routine visits, up to 60 months
Other	T-DXd dose modifications	To evaluate treatment modifications in patients treated with T-DXd in a real-world setting	during routine visits, up to 60 months
Other	Description of DiGA user and non-user population	Age, Education, Family status, depressive mood, diagnostic testing, HR-status, Stage IV at initial diagnosis, localization of metastases, presence or history of (in) active brain metastases, previous therapies, subsequent therapies, center characteristics, DiGA usage	assessed up to 60 months
Primary	Real-world Time To Next Treatment (rwTTNT1)	rwTTNT1 is defined as the time from T-DXd initiation to initiation of subsequent therapy	From first dose of T-DXd until initiation of subsequent therapy or death of any cause, whichever came first, assessed up to 60 months
Secondary	Change in HRQoL based on FACT-B questionnaire at 6 months after baseline	To evaluate patient-reported outcomes (PROs)/ health-related quality of life (HRQoL) based on FACT-B questionnaire at 6 months after baseline. The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQoL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS). FACT-B will be collected electronically at time points synchronized with clinic visits during the study.	6 months
Secondary	Change in HRQoL based on FACT-G questionnaire at 6 months after baseline	To evaluate patient-reported outcomes (PROs)/ health-related quality of life (HRQoL) based on FACT-G questionnaire at 6 months after baseline. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQoL in cancer patients: Physical, social, emotional, and functional well-being. FACT-G will be collected electronically at time points synchronized with clinic visits during the study.	6 months