Breast NeoplasmsPROVIDENCENCT05573893
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
An observational study of Breast Neoplasms and Breast Cancer, run by AstraZeneca at 109 sites in Germany.
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, HER2-low or HER2-ultralow unresectable or metastatic breast… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Breast Neoplasms, Breast Cancer, Neoplasm Metastasis
- How many people
- 800 participants
- Where
- 109 sitesGermany
- Study dates
- 12 Sep 2023to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
109 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
109 sites in 1 country
Germany109 sites, 105 recruiting
- Withdrawn
Research Site
Amberg, 92224
- Withdrawn
Research Site
Ansbach, 91522
- Recruiting
Research Site
Apolda, 99510
- Recruiting
Research Site
Aschaffenburg, 63739
- Recruiting
Research Site
Augsburg, 86150
- Recruiting
Research Site
Augsburg, 86156
- Recruiting
Research Site
Bad Reichenhall, 83435
- Recruiting
Research Site
Baden-Baden, 76532
- Recruiting
Research Site
Balingen, 72336
- Recruiting
Research Site
Bamberg, 96049
- Recruiting
Research Site
Berlin, 10117
- Recruiting
Research Site
Berlin, 10367
- Recruiting
Research Site
Berlin, 10715
- Recruiting
Research Site
Berlin, 12623
- Recruiting
Research Site
Berlin, 13125
- Recruiting
Research Site
Bielefeld, 33604
- Recruiting
Research Site
Bonn, 53111
- Recruiting
Research Site
Brandenburg an der Havel, 14770
- Recruiting
Research Site
Braunschweig, 38100
- Recruiting
Research Site
Bremen, 28209
- Recruiting
Research Site
Bremerhaven, 27574
- Recruiting
Research Site
Coburg, 96450
- Recruiting
Research Site
Dessau, 6847
- Recruiting
Research Site
Donauwörth, 86609
- Recruiting
Research Site
Dortmund, 44137
- Recruiting
Research Site
Dresden, 1127
- Recruiting
Research Site
Dresden, 1307
- Recruiting
Research Site
Düsseldorf, 40235
- Recruiting
Research Site
Eggenfelden, 84307
- Withdrawn
Research Site
Erfurt, 99085
- Recruiting
Research Site
Essen, 45147
- Recruiting
Research Site
Filderstadt - Bonlanden, 70794
- Recruiting
Research Site
Frankfurt, 60389
- Recruiting
Research Site
Freudenstadt, 72250
- Recruiting
Research Site
Fürstenfeldbruck, 82256
- Recruiting
Research Site
Fürstenwalde, 15517
- Recruiting
Research Site
Gerlingen, 70839
- Recruiting
Research Site
Giessen, 35392
- Recruiting
Research Site
Halle, 6110
- Recruiting
Research Site
Hamburg, 20259
- Recruiting
Research Site
Hamburg, 21073
- Recruiting
Research Site
Hanover, 30161
- Recruiting
Research Site
Hanover, 30449
- Recruiting
Research Site
Hansestadt Salzwedel, 29410
- Recruiting
Research Site
Heidenheim, 89522
- Recruiting
Research Site
Heilbronn, 74078
- Recruiting
Research Site
Hildesheim, 31134
- Recruiting
Research Site
Homburg/Saar, 66421
- Recruiting
Research Site
Jena, 7747
- Recruiting
Research Site
Kaiserslautern, 67655
- Recruiting
Research Site
Karlsruhe, 76135
- Recruiting
Research Site
Kassel, 34117
- Recruiting
Research Site
Kassel, 34125
- Recruiting
Research Site
Kempten, 87439
- Recruiting
Research Site
Kiel, 24116
- Recruiting
Research Site
Krefeld, 47805
- Recruiting
Research Site
Kulmbach, 95326
- Recruiting
Research Site
Landshut, 84036
- Recruiting
Research Site
Leer, 26789
- Recruiting
Research Site
Leipzig, 4103
- Recruiting
Research Site
Loerrach, 79539
- Recruiting
Research Site
Lübeck, 23562
- Recruiting
Research Site
Lüneburg, 21339
- Recruiting
Research Site
Magdeburg, 39130
- Recruiting
Research Site
Mainz, 55131
- Recruiting
Research Site
Marburg, 35037
- Recruiting
Research Site
Memmingen, 87700
- Recruiting
Research Site
Mönchengladbach, 41061
- Recruiting
Research Site
Mühlhausen, 99974
- Recruiting
Research Site
München, 80638
- Recruiting
Research Site
München, 80639
- Recruiting
Research Site
München, 81377
- Recruiting
Research Site
Mutlangen, 73557
- Withdrawn
Research Site
Neumarkt, 92318
- Recruiting
Research Site
Neuruppin, 16816
- Recruiting
Research Site
Neustadt am Rübenberge, 31535
- Recruiting
Research Site
Nordhausen, 99734
- Recruiting
Research Site
Nuremberg, 90419
- Recruiting
Research Site
Oldenburg, 26121
- Recruiting
Research Site
Oranienburg, 16515
- Recruiting
Research Site
Potsdam, 14467
- Recruiting
Research Site
Recklinghausen, 45659
- Recruiting
Research Site
Regensburg, 93053
- Recruiting
Research Site
Rosenheim, 83022
- Recruiting
Research Site
Rotenburg (Wümme), 27356
- Recruiting
Research Site
Saalfeld, 7318
- Recruiting
Research Site
Saarbrücken, 66113
- Recruiting
Research Site
Schwäbisch Hall, 74523
- Recruiting
Research Site
Siegen, 57072
- Recruiting
Research Site
Singen, 78224
- Recruiting
Research Site
Solingen, 42653
- Recruiting
Research Site
Stade, 21680
- Recruiting
Research Site
Stuttgart, 70199
- Recruiting
Research Site
Torgau, 4860
- Recruiting
Research Site
Troisdorf, 53840
- Recruiting
Research Site
Ulm, 89073
- Recruiting
Research Site
Ulm, 89075
- Recruiting
Research Site
Walsrode, 29664
- Recruiting
Research Site
Weiden, 92637
- Recruiting
Research Site
Weinheim, 69469
- Recruiting
Research Site
Wessenfels, 6667
- Recruiting
Research Site
Westerstede, 26655
- Recruiting
Research Site
Wiesbaden, 65199
- Recruiting
Research Site
Winnenden, 71364
- Recruiting
Research Site
Witten, 58452
- Recruiting
Research Site
Wolfsburg, 38440
- Recruiting
Research Site
Wuppertal, 42283
- Recruiting
Research Site
Würzburg, 97080
- Recruiting
Research Site
Zittau, 02763
About this study
Official 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
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).
Read the detailed description
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.
- Conditions
- Breast Neoplasms, Breast Cancer, Neoplasm Metastasis
- Keywords
- Trastuzumab-Deruxtecan,, Human epidermal growth factor receptor 2 Positive Breast Cancer,, Human epidermal growth factor receptor 2 Low Breast Cancer,, Human epidermal growth factor receptor 2 Ultralow Breast Cancer,
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Time To Next Treatment (rwTTNT1)
rwTTNT1 is defined as the time from T-DXd initiation to initiation of subsequent therapy
Measured: 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
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start12 Sep 2023
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573893
- Sponsor's protocol ID
- D9673R00028
- Acronym
- PROVIDENCE
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05573893
- Acronym / sponsor ID
- PROVIDENCE / D9673R00028
- Conditions
- Breast Neoplasms, Breast Cancer, Neoplasm Metastasis
- Keywords
- Trastuzumab-Deruxtecan,, Human epidermal growth factor receptor 2 Positive Breast Cancer,, Human epidermal growth factor receptor 2 Low Breast Cancer,, Human epidermal growth factor receptor 2 Ultralow Breast Cancer,
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- Adults ≥ 18 years old
- Patients (irrespective of sex and gender) with pathologically documented breast cancer that:
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Change in HRQoL based on FACT-B questionnaire at 6 months after baseline
Time frame: 6 months
Change in HRQoL based on FACT-G questionnaire at 6 months after baseline
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
109 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Breast Cancer, run by AstraZeneca at 109 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.