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

Last updated: February 25, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Neoplasms

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT05573893
D9673R00028
  • Ages 18-130
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults ≥ 18 years old

  2. Patients (irrespective of sex and gender) with pathologically documented breastcancer 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 tumoris HER2+ OR

  • was previously treated with at least one endocrine therapy in the metastaticsetting and is not considered suitable for endocrine therapy as the next lineof treatment if the tumor is HR+, HER2-low or HER2-ultralow OR

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

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

  2. Patient is eligible for T-DXd treatment in line with the specifications mentioned inthe ENHERTU® SmPC and is scheduled for T-DXd treatment *

  3. Patient is able to read and understand either German or English

  4. Signed written informed consent

  • The prescription of the medicinal product is clearly separated from thedecision to include the patient in this NIS.

Exclusion

Exclusion Criteria:

  1. Start of T-DXd treatment for more than 30 days before enrolment (eCRF registrationdate)

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

  3. Pregnancy or breast feeding

  4. Current or planned participation in an interventional clinical trial

  5. Current or planned systemic treatment of any tumor other than unresectable ormetastatic 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.

Study Design

Total Participants: 800
Study Start date:
September 12, 2023
Estimated Completion Date:
December 31, 2031

Study 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.

Connect with a study center

  • Research Site

    Amberg, 92224
    Germany

    Site Not Available

  • Research Site

    Amberg 2956656, 92224
    Germany

    Site Not Available

  • Research Site

    Ansbach, 91522
    Germany

    Site Not Available

  • Research Site

    Ansbach 2955936, 91522
    Germany

    Site Not Available

  • Research Site

    Apolda, 99510
    Germany

    Site Not Available

  • Research Site

    Apolda 2955770, 99510
    Germany

    Active - Recruiting

  • Research Site

    Aschaffenburg, 63739
    Germany

    Site Not Available

  • Research Site

    Aschaffenburg 2955272, 63739
    Germany

    Active - Recruiting

  • Research Site

    Augsburg, 86156
    Germany

    Site Not Available

  • Research Site

    Augsburg 2954172, 86156
    Germany

    Active - Recruiting

  • Research Site

    Bad Reichenhall, 83435
    Germany

    Site Not Available

  • Research Site

    Bad Reichenhall 2953371, 83435
    Germany

    Active - Recruiting

  • Research Site

    Baden-Baden, 76532
    Germany

    Site Not Available

  • Research Site

    Baden-Baden 2953504, 76532
    Germany

    Active - Recruiting

  • Research Site

    Balingen 2953089, 72336
    Germany

    Active - Recruiting

  • Research Site

    Bamberg 2952984, 96049
    Germany

    Active - Recruiting

  • Research Site

    Beremerhaven, 27574
    Germany

    Site Not Available

  • Research Site

    Berlin, 10367
    Germany

    Site Not Available

  • Research Site

    Berlin 2950159, 10367
    Germany

    Active - Recruiting

  • Research Site

    Bielefeld, 33604
    Germany

    Site Not Available

  • Research Site

    Bielefeld 2949186, 33604
    Germany

    Active - Recruiting

  • Research Site

    Bonn, 53111
    Germany

    Site Not Available

  • Research Site

    Bonn 2946447, 53111
    Germany

    Active - Recruiting

  • Research Site

    Brandenburg 2945358, 14770
    Germany

    Active - Recruiting

  • Research Site

    Brandenburg an der Havel, 14770
    Germany

    Site Not Available

  • Research Site

    Braunschweig, 38100
    Germany

    Site Not Available

  • Research Site

    Braunschweig 2945024, 38100
    Germany

    Active - Recruiting

  • Research Site

    Bremen, 28209
    Germany

    Site Not Available

  • Research Site

    Bremen 2944388, 28209
    Germany

    Active - Recruiting

  • Research Site

    Bremerhaven, 27574
    Germany

    Site Not Available

  • Research Site

    Bremerhaven 2944368, 27574
    Germany

    Active - Recruiting

  • Research Site

    Coburg, 96450
    Germany

    Site Not Available

  • Research Site

    Coburg 2939951, 96450
    Germany

    Active - Recruiting

  • Research Site

    Dessau, 6847
    Germany

    Site Not Available

  • Research Site

    Dessau 2937959, 6847
    Germany

    Active - Recruiting

  • Research Site

    Donauwoerth, 86609
    Germany

    Site Not Available

  • Research Site

    Donauwörth 2936253, 86609
    Germany

    Active - Recruiting

  • Research Site

    Dortmund, 44137
    Germany

    Site Not Available

  • Research Site

    Dortmund 2935517, 44137
    Germany

    Active - Recruiting

  • Research Site

    Dresden, 1307
    Germany

    Site Not Available

  • Research Site

    Dresden 2935022, 1127
    Germany

    Active - Recruiting

  • Research Site

    Duesseldorf, 40235
    Germany

    Site Not Available

  • Research Site

    Düsseldorf 2934246, 40235
    Germany

    Active - Recruiting

  • Research Site

    Eggenfelden, 84307
    Germany

    Site Not Available

  • Research Site

    Eggenfelden 2933115, 84307
    Germany

    Active - Recruiting

  • Research Site

    Erfurt, 99085
    Germany

    Site Not Available

  • Research Site

    Erfurt 2929670, 99085
    Germany

    Site Not Available

  • Research Site

    Essen, 45147
    Germany

    Site Not Available

  • Research Site

    Essen 2928810, 45147
    Germany

    Active - Recruiting

  • Research Site

    Filderstadt - Bonlanden, 70794
    Germany

    Active - Recruiting

  • Research Site

    Frankfurt, 60389
    Germany

    Site Not Available

  • Research Site

    Frankfurt 2925536, 60389
    Germany

    Active - Recruiting

  • Research Site

    Freudenstadt, 72250
    Germany

    Site Not Available

  • Research Site

    Freudenstadt 2924894, 72250
    Germany

    Active - Recruiting

  • Research Site

    Fuerstenfeldbruck, 82256
    Germany

    Site Not Available

  • Research Site

    Fuerstenwalde, 15517
    Germany

    Site Not Available

  • Research Site

    Fürstenfeldbruck 2923625, 82256
    Germany

    Active - Recruiting

  • Research Site

    Fürstenwalde 2923588, 15517
    Germany

    Active - Recruiting

  • Research Site

    Gerlingen, 70839
    Germany

    Site Not Available

  • Research Site

    Gerlingen 2921061, 70839
    Germany

    Active - Recruiting

  • Research Site

    Giessen, 35392
    Germany

    Site Not Available

  • Research Site

    Giessen 2920512, 35392
    Germany

    Active - Recruiting

  • Research Site

    Halle 2911522, 6110
    Germany

    Active - Recruiting

  • Research Site

    Halle (Saale), 6110
    Germany

    Site Not Available

  • Research Site

    Hamburg, 20259
    Germany

    Site Not Available

  • Research Site

    Hamburg 2911298, 20259
    Germany

    Active - Recruiting

  • Research Site

    Hannover, 30449
    Germany

    Site Not Available

  • Research Site

    Hanover 2910831, 30161
    Germany

    Active - Recruiting

  • Research Site

    Heidenheim, 89522
    Germany

    Site Not Available

  • Research Site

    Heidenheim 2907851, 89522
    Germany

    Active - Recruiting

  • Research Site

    Heilbronn, 74078
    Germany

    Site Not Available

  • Research Site

    Heilbronn 2907669, 74078
    Germany

    Active - Recruiting

  • Research Site

    Hildesheim, 31134
    Germany

    Site Not Available

  • Research Site

    Hildesheim 2904789, 31134
    Germany

    Active - Recruiting

  • Research Site

    Homburg/Saar, 66421
    Germany

    Active - Recruiting

  • Research Site

    Jena, 7747
    Germany

    Site Not Available

  • Research Site

    Jena 2895044, 7747
    Germany

    Active - Recruiting

  • Research Site

    Kaiserslautern, 67655
    Germany

    Site Not Available

  • Research Site

    Kaiserslautern 2894003, 67655
    Germany

    Active - Recruiting

  • Research Site

    Karlsruhe, 76135
    Germany

    Site Not Available

  • Research Site

    Karlsruhe 2892794, 76135
    Germany

    Active - Recruiting

  • Research Site

    Kassel, 34125
    Germany

    Site Not Available

  • Research Site

    Kassel 2892518, 34125
    Germany

    Active - Recruiting

  • Research Site

    Kempten, 87439
    Germany

    Site Not Available

  • Research Site

    Kempten 2891620, 87439
    Germany

    Active - Recruiting

  • Research Site

    Kiel, 24116
    Germany

    Site Not Available

  • Research Site

    Kiel 2891122, 24116
    Germany

    Active - Recruiting

  • Research Site

    Krefeld 2884509, 47805
    Germany

    Active - Recruiting

  • Research Site

    Kulmbach, 95326
    Germany

    Site Not Available

  • Research Site

    Kulmbach 2882588, 95326
    Germany

    Active - Recruiting

  • Research Site

    L Neburg, 21339
    Germany

    Site Not Available

  • Research Site

    Landshut, 84036
    Germany

    Site Not Available

  • Research Site

    Landshut 2881485, 84036
    Germany

    Active - Recruiting

  • Research Site

    Leer, 26789
    Germany

    Site Not Available

  • Research Site

    Leer 2879697, 26789
    Germany

    Active - Recruiting

  • Research Site

    Leipzig, 4103
    Germany

    Site Not Available

  • Research Site

    Leipzig 2879139, 4103
    Germany

    Active - Recruiting

  • Research Site

    Loerrach, 79539
    Germany

    Site Not Available

  • Research Site

    Loerrach 2875881, 79539
    Germany

    Active - Recruiting

  • Research Site

    Luebeck, 23562
    Germany

    Site Not Available

  • Research Site

    Lueneburg, 21339
    Germany

    Site Not Available

  • Research Site

    Luneburg, 21339
    Germany

    Site Not Available

  • Research Site

    Lübeck 2875601, 23562
    Germany

    Active - Recruiting

  • Research Site

    Lüneburg, 21339
    Germany

    Site Not Available

  • Research Site

    Lüneburg 2875115, 21339
    Germany

    Active - Recruiting

  • Research Site

    M Hlhausen, 99974
    Germany

    Site Not Available

  • Research Site

    Magdeburg, 39130
    Germany

    Site Not Available

  • Research Site

    Magdeburg 2874545, 39130
    Germany

    Active - Recruiting

  • Research Site

    Mainz, 55131
    Germany

    Site Not Available

  • Research Site

    Mainz 2874225, 55131
    Germany

    Active - Recruiting

  • Research Site

    Marburg, 35037
    Germany

    Site Not Available

  • Research Site

    Marburg 2873759, 35037
    Germany

    Active - Recruiting

  • Research Site

    Memmingen, 87700
    Germany

    Site Not Available

  • Research Site

    Memmingen 2871992, 87700
    Germany

    Active - Recruiting

  • Research Site

    Moenchengladbach, 41061
    Germany

    Site Not Available

  • Research Site

    Muehlhausen, 99974
    Germany

    Site Not Available

  • Research Site

    Muenchen, 80639
    Germany

    Site Not Available

  • Research Site

    Muhlhausen, 99974
    Germany

    Site Not Available

  • Research Site

    Mutlangen, 73557
    Germany

    Site Not Available

  • Research Site

    Mutlangen 2867335, 73557
    Germany

    Active - Recruiting

  • Research Site

    Mönchengladbach 2869894, 41061
    Germany

    Active - Recruiting

  • Research Site

    Mühlhausen, 99974
    Germany

    Site Not Available

  • Research Site

    Mühlhausen 2867996, 99974
    Germany

    Active - Recruiting

  • Research Site

    München 2867711, 80638
    Germany

    Active - Recruiting

  • Research Site

    Neumarkt, 92318
    Germany

    Site Not Available

  • Research Site

    Neumarkt 2864550, 92318
    Germany

    Site Not Available

  • Research Site

    Neumarkt 6691074, 92318
    Germany

    Site Not Available

  • Research Site

    Neustadt Am Ruebenberge, 31535
    Germany

    Site Not Available

  • Research Site

    Neustadt am Rübenberge 2864058, 31535
    Germany

    Active - Recruiting

  • Research Site

    Nordhausen, 99734
    Germany

    Site Not Available

  • Research Site

    Nordhausen 2861982, 99734
    Germany

    Active - Recruiting

  • Research Site

    Nuremberg 2861650, 90419
    Germany

    Active - Recruiting

  • Research Site

    Nurnberg, 90419
    Germany

    Site Not Available

  • Research Site

    Nürnberg, 90419
    Germany

    Site Not Available

  • Research Site

    Oldenburg, 26121
    Germany

    Site Not Available

  • Research Site

    Oldenburg 2857458, 26121
    Germany

    Active - Recruiting

  • Research Site

    Oranienburg, 16515
    Germany

    Site Not Available

  • Research Site

    Oranienburg 2857129, 16515
    Germany

    Active - Recruiting

  • Research Site

    Potsdam, 14467
    Germany

    Site Not Available

  • Research Site

    Potsdam 2852458, 14467
    Germany

    Active - Recruiting

  • Research Site

    Recklinghausen, 45659
    Germany

    Site Not Available

  • Research Site

    Recklinghausen 2849647, 45659
    Germany

    Active - Recruiting

  • Research Site

    Regensburg, 93053
    Germany

    Site Not Available

  • Research Site

    Regensburg 2849483, 93053
    Germany

    Active - Recruiting

  • Research Site

    Rosenheim, 83022
    Germany

    Site Not Available

  • Research Site

    Rosenheim 2844988, 83022
    Germany

    Active - Recruiting

  • Research Site

    Rotenburg (Wuemme), 27356
    Germany

    Site Not Available

  • Research Site

    Rotenburg (Wümme) 2844437, 27356
    Germany

    Active - Recruiting

  • Research Site

    Saalfeld 2842688, 7318
    Germany

    Active - Recruiting

  • Research Site

    Saalfeld (Saale), 7318
    Germany

    Site Not Available

  • Research Site

    Saarbruecken, 66113
    Germany

    Site Not Available

  • Research Site

    Saarbrücken 2842647, 66113
    Germany

    Active - Recruiting

  • Research Site

    Salzwedel, 29410
    Germany

    Site Not Available

  • Research Site

    Salzwedel 2842112, 29410
    Germany

    Active - Recruiting

  • Research Site

    Schwaebisch-Hall, 74523
    Germany

    Site Not Available

  • Research Site

    Schwäbisch Hall 2835481, 74523
    Germany

    Active - Recruiting

  • Research Site

    Siegen 2832495, 57072
    Germany

    Active - Recruiting

  • Research Site

    Singen, 78224
    Germany

    Site Not Available

  • Research Site

    Singen 2831924, 78224
    Germany

    Active - Recruiting

  • Research Site

    Solingen, 42653
    Germany

    Site Not Available

  • Research Site

    Solingen 2831580, 42653
    Germany

    Active - Recruiting

  • Research Site

    Stade, 21680
    Germany

    Site Not Available

  • Research Site

    Stade 2829901, 21680
    Germany

    Active - Recruiting

  • Research Site

    Stuttgart, 70199
    Germany

    Site Not Available

  • Research Site

    Stuttgart 2825297, 70199
    Germany

    Active - Recruiting

  • Research Site

    Torgau, 4860
    Germany

    Site Not Available

  • Research Site

    Torgau 2821807, 4860
    Germany

    Active - Recruiting

  • Research Site

    Troisdorf, 53840
    Germany

    Site Not Available

  • Research Site

    Troisdorf 2821029, 53840
    Germany

    Active - Recruiting

  • Research Site

    Ulm, 89073
    Germany

    Site Not Available

  • Research Site

    Ulm 2820256, 89073
    Germany

    Active - Recruiting

  • Research Site

    Walsrode, 29664
    Germany

    Site Not Available

  • Research Site

    Walsrode 2814462, 29664
    Germany

    Active - Recruiting

  • Research Site

    Wei Enfels, 6667
    Germany

    Site Not Available

  • Research Site

    Weiden, 92637
    Germany

    Site Not Available

  • Research Site

    Weiden 2813040, 92637
    Germany

    Active - Recruiting

  • Research Site

    Weinheim, 69469
    Germany

    Site Not Available

  • Research Site

    Weinheim 2812174, 69469
    Germany

    Active - Recruiting

  • Research Site

    Weisenfels, 6667
    Germany

    Site Not Available

  • Research Site

    Weissenfels, 6667
    Germany

    Site Not Available

  • Research Site

    Weißenfels, 6667
    Germany

    Site Not Available

  • Research Site

    Weißenfels 2811899, 6667
    Germany

    Active - Recruiting

  • Research Site

    Westerstede, 26655
    Germany

    Site Not Available

  • Research Site

    Westerstede 2810188, 26655
    Germany

    Active - Recruiting

  • Research Site

    Wiesbaden, 65199
    Germany

    Site Not Available

  • Research Site

    Wiesbaden 2809346, 65199
    Germany

    Active - Recruiting

  • Research Site

    Winnenden, 71364
    Germany

    Site Not Available

  • Research Site

    Winnenden 2807872, 71364
    Germany

    Active - Recruiting

  • Research Site

    Witten 2807363, 58452
    Germany

    Active - Recruiting

  • Research Site

    Wolfsburg, 38440
    Germany

    Site Not Available

  • Research Site

    Wolfsburg 2806654, 38440
    Germany

    Active - Recruiting

  • Research Site

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Research Site

    Wuppertal, 42283
    Germany

    Site Not Available

  • Research Site

    Wuppertal 2805753, 42283
    Germany

    Active - Recruiting

  • Research Site

    Würzburg 2805615, 97080
    Germany

    Active - Recruiting

  • Research Site

    Zittau, 02763
    Germany

    Site Not Available

  • Research Site

    Zittau 2804008, 02763
    Germany

    Active - Recruiting

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