PROVIDENCE - Real-world Study in Patients With HER2-positive Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan and Offered PRO-React Onco

Sponsor

AstraZeneca (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05573893

Collaborator

Daiichi Sankyo, Inc. (Industry)

390

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan in patients with Human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic breast cancer, who were offered to use CANKADO PRO-React Onco, in Germany.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Breast Cancer Neoplasm Metastasis

Detailed Description

Eligible participants will be those diagnosed with HER2-positive, unresectable or metastatic breast cancer, who have received one prior HER2-targeted therapy and are now scheduled to receive T-DXd in second line.

Further, all eligible participants are offered to use CANCADO PRO-React Onco, an in Germany approved and reimbursed digital healthcare application (DiGA) for assistance of patients with breast cancer and their oncologist during cancer treatment.

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 and DiGA are considered as a selection criteria.

Approximately 390 eligible participants will be enrolled into 1 of 2 cohorts, according to the CANKADO PRO-React Onco user behavior.

Study Design

Study Type:

Observational

Anticipated Enrollment :

390 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Non-interventional Study (NIS) to Examine the Impact of eHealth Support on Patient-reported Outcomes and on Real World Clinical Data in Patients With HER2-positive Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan

Anticipated Study Start Date :

Oct 31, 2022

Anticipated Primary Completion Date :

Dec 31, 2029

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Cohort 1 containing patients with documentation of a CANKADO PRO-React Onco questionnaire on at least 30 days during the first 90 days after activating/ first usage of the DiGA within the study.
Cohort 2 Cohort 2 containing patients with documentation of a CANKADO PRO-React Onco questionnaire on less than 30 days during the first 90 days after activating/ first usage of the DiGA within the study or having stated at baseline to decline CANKADO PRO-React Onco usage.

Outcome Measures

Primary Outcome Measures

Difference in HRQoL based on FACT-B questionnaire at 6 months after baseline between Cohort 1 and Cohort 2 [6 months]
To evaluate if usage of CANKADO PRO-React Onco influences patient-reported outcomes (PROs)/ health-related quality of life (HRQoL) based on FACT-B questionnaire in patients with HER2+ unresectable or metastatic BC treated with T-DXd therapy in 2L in the real-world setting. 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 synchronised with clinic visits during the study.

Secondary Outcome Measures

Difference in HRQoL based on FACT-G questionnaire at 6 months after baseline between Cohort 1 and Cohort 2. [6 months]
To evaluate if usage of CANKADO PRO-React Onco influences patient-reported outcomes (PROs)/ health-related quality of life (HRQoL) based on FACT-G questionnaire in patients with HER2+ unresectable or metastatic BC treated with T-DXd therapy in 2L in the real-world setting. 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.

Other Outcome Measures

Change in HRQoL based on FACT-B questionnaire compared to baseline over time [Patient questionnaires will be collected at time points synchronised with clinic visits during study, assessed up to 60 months]
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).
Change in HRQoL based on EQ-5D questionnaire compared to baseline over time [Patient questionnaires will be collected at time points synchronised with clinic visits during study, assessed up to 60 months]
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.
Real-world Overall Response Rate (rwORR) [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 month]
rwORR is defined as percentage of patients having complete response or partial response as best response as determined by the investigator
Real-world Progression-free Survival (rwPFS) [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]
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
Real-world Overall Survival (rwOS) [From first dose of T-DXd until death of any cause, assessed up to 60 months]
rwOS is defined as time from T-DXd initiation to date of death
Real-world Time To Next Treatment (rwTTNT1) [From first dose of T-DXd until initiation of subsequent therapy or death of any cause, whichever came first, assessed up to 60 months]
rwTTNT1 is defined as the time from T-DXd initiation to initiation of subsequent therapy
Real-world Time To Treatment Discontinuation (rwTTD) [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]
rwTTD is defined as time from T-DXd initiation to discontinuation, or death
Real-world Time To Next Treatment 2 [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]
rwTTNT2 is defined as time from initiation of T-DXd treatment to initiation of second next treatment, or death
Reql-world Time to Treament Discontinuation 2 (rwTTD2) [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]
rwTTD2 is defined as time from initiation T-DXd treatment to discontinuation of corresponding subsequent therapy, or death
Real-world Progression-free Survival (rwPFS2) [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]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults ≥ 18 years old
Patients with pathologically documented breast cancer that:
is unresectable or metastatic
has confirmed HER2+ tumor status by local pathology
was previously treated with one anti-HER2 directed therapy
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*
Patient is offered to use CANKADO PRO-React Onco as a digital health application (Digitale Gesundheitsanwendung; DiGA)
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