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NCT Number: NCT05573893

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

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, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (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).

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Key information

Conditions

Breast Neoplasms Breast Cancer Breast Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Amberg, Germany

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About this study

Eligible participants will be those patients with documented HER2-positive, HER2-low or HER2-ultralow 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/ HER2-ultralow cohort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥ 18 years old
  • Patients (irrespective of sex and gender) with pathologically documented breast cancer that:
  • is unresectable or metastatic
  • has confirmed HER2+, HER2-low or HER2-ultralow tumor status by local pathology
  • was previously treated with one or more anti-HER2 directed therapy if the tumor is HER2+ OR
  • was previously treated with at least one endocrine therapy in the metastatic setting and is not considered suitable for endocrine therapy as the next line of treatment if the tumor is HR+, HER2-low or HER2-ultralow 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 treatment *
  • Patient is able to read and understand either German or English
  • Signed written informed consent
  • The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS.

Exclusion criteria

  • Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date)
  • 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

Patients who have never received any T-DXd dose will be discontinued from the study and will be considered as a late screening failure, no further documentation besides reason and date of discontinuation is needed.

Treatment and study plan

Primary outcomes

  1. Real-world Time To Next Treatment (rwTTNT1)

    Time frame: 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

Secondary outcomes

  1. Change in HRQoL based on FACT-B questionnaire at 6 months after baseline

    Time frame: 6 months

    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.

  2. Change in HRQoL based on FACT-G questionnaire at 6 months after baseline

    Time frame: 6 months

    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.

Other outcomes

  1. Change in HRQoL based on FACT-B questionnaire compared to baseline over time

    Time frame: 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).

  2. Change in HRQoL based on EQ-5D questionnaire compared to baseline over time

    Time frame: 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.

  3. Real-world Overall Response Rate (rwORR)

    Time frame: 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

    rwORR is defined as percentage of patients having complete response or partial response as best response as determined by the investigator

  4. Real-world Progression-free Survival (rwPFS)

    Time frame: 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

  5. Real-world Overall Survival (rwOS)

    Time frame: 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

  6. Real-world Time To Treatment Discontinuation (rwTTD)

    Time frame: 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

  7. Real-world Time To Next Treatment 2 (rwTTNT2)

    Time frame: 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

  8. Real-world Time to Treament Discontinuation 2 (rwTTD2)

    Time frame: 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

  9. Real-world Progression-free Survival (rwPFS2)

    Time frame: 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

  10. Safety: Collection of Adverse Events (AE)

    Time frame: during routine visits, up to 60 months

    Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness

  11. T-DXd dose modifications

    Time frame: during routine visits, up to 60 months

    To evaluate treatment modifications in patients treated with T-DXd in a real-world setting

  12. Description of DiGA user and non-user population

    Time frame: assessed up to 60 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Daiichi Sankyo

Registry information

Official study title

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

Acronym: PROVIDENCE

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Oct 10, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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