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
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
1 other identifier
observational
800
1 country
107
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 (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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Longer than P75 for all trials
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedStudy Start
First participant enrolled
September 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
February 27, 2026
February 1, 2026
8.3 years
September 29, 2022
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in HRQoL based on FACT-B questionnaire at 6 months after baseline
6 months
Change in HRQoL based on FACT-G questionnaire at 6 months after baseline
6 months
Other Outcomes (12)
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
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
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 months
- +9 more other outcomes
Study Arms (2)
Cohort 1
Cohort 1 containing patients with documented HER2-positive unresectable or metastatic BC receiving T-DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice.
Cohort 2
Cohort 2 containing patients with documented 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.
Eligibility Criteria
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 may participate in this NIS.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyocollaborator
Study Sites (107)
Research Site
Amberg, 92224, Germany
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Ansbach, 91522, Germany
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Apolda, 99510, Germany
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Aschaffenburg, 63739, Germany
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Augsburg, 86150, Germany
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Augsburg, 86156, Germany
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Bad Reichenhall, 83435, Germany
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Baden-Baden, 76532, Germany
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Balingen, 72336, Germany
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Bamberg, 96049, Germany
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Berlin, 10117, Germany
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Berlin, 10367, Germany
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Berlin, 10715, Germany
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Berlin, 12623, Germany
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Berlin, 13125, Germany
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Bielefeld, 33604, Germany
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Bonn, 53111, Germany
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Brandenburg, 14770, Germany
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Braunschweig, 38100, Germany
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Bremen, 28209, Germany
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Bremerhaven, 27574, Germany
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Coburg, 96450, Germany
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Dessau, 6847, Germany
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Donauwörth, 86609, Germany
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Dortmund, 44137, Germany
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Dresden, 1127, Germany
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Dresden, 1307, Germany
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Düsseldorf, 40235, Germany
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Eggenfelden, 84307, Germany
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Erfurt, 99085, Germany
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Essen, 45147, Germany
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Filderstadt - Bonlanden, 70794, Germany
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Frankfurt, 60389, Germany
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Freudenstadt, 72250, Germany
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Fürstenfeldbruck, 82256, Germany
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Fürstenwalde, 15517, Germany
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Gerlingen, 70839, Germany
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Giessen, 35392, Germany
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Halle, 6110, Germany
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Hamburg, 20259, Germany
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Hamburg, 21073, Germany
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Hanover, 30161, Germany
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Hanover, 30449, Germany
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Heidenheim, 89522, Germany
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Heilbronn, 74078, Germany
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Hildesheim, 31134, Germany
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Homburg/Saar, 66421, Germany
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Jena, 7747, Germany
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Kaiserslautern, 67655, Germany
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Karlsruhe, 76135, Germany
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Kassel, 34117, Germany
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Kassel, 34125, Germany
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Kempten, 87439, Germany
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Kiel, 24116, Germany
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Krefeld, 47805, Germany
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Kulmbach, 95326, Germany
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Landshut, 84036, Germany
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Leer, 26789, Germany
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Leipzig, 4103, Germany
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Loerrach, 79539, Germany
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Lübeck, 23562, Germany
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Lüneburg, 21339, Germany
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Magdeburg, 39130, Germany
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Mainz, 55131, Germany
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Marburg, 35037, Germany
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Memmingen, 87700, Germany
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Mönchengladbach, 41061, Germany
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Mutlangen, 73557, Germany
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Mühlhausen, 99974, Germany
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München, 80638, Germany
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München, 80639, Germany
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München, 81377, Germany
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Neumarkt, 92318, Germany
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Neustadt am Rübenberge, 31535, Germany
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Nordhausen, 99734, Germany
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Nuremberg, 90419, Germany
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Oldenburg, 26121, Germany
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Oranienburg, 16515, Germany
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Potsdam, 14467, Germany
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Recklinghausen, 45659, Germany
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Regensburg, 93053, Germany
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Rosenheim, 83022, Germany
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Rotenburg (Wümme), 27356, Germany
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Saalfeld, 7318, Germany
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Saarbrücken, 66113, Germany
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Salzwedel, 29410, Germany
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Schwäbisch Hall, 74523, Germany
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Siegen, 57072, Germany
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Singen, 78224, Germany
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Solingen, 42653, Germany
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Stade, 21680, Germany
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Stuttgart, 70199, Germany
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Torgau, 4860, Germany
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Troisdorf, 53840, Germany
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Ulm, 89073, Germany
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Walsrode, 29664, Germany
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Weiden, 92637, Germany
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Weinheim, 69469, Germany
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Weißenfels, 6667, Germany
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Westerstede, 26655, Germany
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Wiesbaden, 65199, Germany
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Winnenden, 71364, Germany
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Witten, 58452, Germany
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Wolfsburg, 38440, Germany
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Wuppertal, 42283, Germany
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Würzburg, 97080, Germany
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Zittau, 02763, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2022
First Posted
October 10, 2022
Study Start
September 12, 2023
Primary Completion (Estimated)
December 31, 2031
Study Completion (Estimated)
December 31, 2031
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.