Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-02-27
800
Participants Needed
107
Research Sites
433 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years old or older
- Patients with pathologically confirmed breast cancer that is unresectable or metastatic
- Tumor status confirmed as HER2-positive, HER2-low, or HER2-ultralow by local pathology
- For HER2-positive tumors: previously treated with one or more anti-HER2 therapies
- For HER2-low or HER2-ultralow tumors with hormone receptor positive (HR+): previously treated with at least one endocrine therapy in the metastatic setting and not suitable for endocrine therapy as next treatment
- For HER2-low tumors: previously treated with chemotherapy in the metastatic setting or developed recurrence during/within 6 months after adjuvant chemotherapy
- Documented radiologic progression during or after most recent treatment
- Eligible for T-DXd treatment according to the ENHERTU® Summary of Product Characteristics and scheduled for T-DXd
- Able to read and understand German or English
- Signed written informed consent
You will not qualify if you...
- Started T-DXd treatment more than 30 days before enrollment
- Known hypersensitivity to T-DXd or any excipients of the drug
- Pregnant or breastfeeding
- Current or planned participation in an interventional clinical trial
- Current or planned systemic treatment for any tumor other than unresectable or metastatic breast cancer
- Patients who have never received any T-DXd dose will be discontinued from the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 107 locations
1
Research Site
Amberg, Germany, 92224
Withdrawn
2
Research Site
Ansbach, Germany, 91522
Withdrawn
3
Research Site
Apolda, Germany, 99510
Actively Recruiting
4
Research Site
Aschaffenburg, Germany, 63739
Actively Recruiting
5
Research Site
Augsburg, Germany, 86150
Actively Recruiting
6
Research Site
Augsburg, Germany, 86156
Actively Recruiting
7
Research Site
Bad Reichenhall, Germany, 83435
Actively Recruiting
8
Research Site
Baden-Baden, Germany, 76532
Actively Recruiting
9
Research Site
Balingen, Germany, 72336
Actively Recruiting
10
Research Site
Bamberg, Germany, 96049
Actively Recruiting
11
Research Site
Berlin, Germany, 10117
Actively Recruiting
12
Research Site
Berlin, Germany, 10367
Actively Recruiting
13
Research Site
Berlin, Germany, 10715
Actively Recruiting
14
Research Site
Berlin, Germany, 12623
Actively Recruiting
15
Research Site
Berlin, Germany, 13125
Actively Recruiting
16
Research Site
Bielefeld, Germany, 33604
Actively Recruiting
17
Research Site
Bonn, Germany, 53111
Actively Recruiting
18
Research Site
Brandenburg an der Havel, Germany, 14770
Actively Recruiting
19
Research Site
Braunschweig, Germany, 38100
Actively Recruiting
20
Research Site
Bremen, Germany, 28209
Actively Recruiting
21
Research Site
Bremerhaven, Germany, 27574
Actively Recruiting
22
Research Site
Coburg, Germany, 96450
Actively Recruiting
23
Research Site
Dessau, Germany, 6847
Actively Recruiting
24
Research Site
Donauwörth, Germany, 86609
Actively Recruiting
25
Research Site
Dortmund, Germany, 44137
Actively Recruiting
26
Research Site
Dresden, Germany, 1127
Actively Recruiting
27
Research Site
Dresden, Germany, 1307
Actively Recruiting
28
Research Site
Düsseldorf, Germany, 40235
Actively Recruiting
29
Research Site
Eggenfelden, Germany, 84307
Actively Recruiting
30
Research Site
Erfurt, Germany, 99085
Withdrawn
31
Research Site
Essen, Germany, 45147
Actively Recruiting
32
Research Site
Filderstadt - Bonlanden, Germany, 70794
Actively Recruiting
33
Research Site
Frankfurt, Germany, 60389
Actively Recruiting
34
Research Site
Freudenstadt, Germany, 72250
Actively Recruiting
35
Research Site
Fürstenfeldbruck, Germany, 82256
Actively Recruiting
36
Research Site
Fürstenwalde, Germany, 15517
Actively Recruiting
37
Research Site
Gerlingen, Germany, 70839
Actively Recruiting
38
Research Site
Giessen, Germany, 35392
Actively Recruiting
39
Research Site
Halle, Germany, 6110
Actively Recruiting
40
Research Site
Hamburg, Germany, 20259
Actively Recruiting
41
Research Site
Hamburg, Germany, 21073
Actively Recruiting
42
Research Site
Hanover, Germany, 30161
Actively Recruiting
43
Research Site
Hanover, Germany, 30449
Actively Recruiting
44
Research Site
Hansestadt Salzwedel, Germany, 29410
Actively Recruiting
45
Research Site
Heidenheim, Germany, 89522
Actively Recruiting
46
Research Site
Heilbronn, Germany, 74078
Actively Recruiting
47
Research Site
Hildesheim, Germany, 31134
Actively Recruiting
48
Research Site
Homburg/Saar, Germany, 66421
Actively Recruiting
49
Research Site
Jena, Germany, 7747
Actively Recruiting
50
Research Site
Kaiserslautern, Germany, 67655
Actively Recruiting
51
Research Site
Karlsruhe, Germany, 76135
Actively Recruiting
52
Research Site
Kassel, Germany, 34117
Actively Recruiting
53
Research Site
Kassel, Germany, 34125
Actively Recruiting
54
Research Site
Kempten, Germany, 87439
Actively Recruiting
55
Research Site
Kiel, Germany, 24116
Actively Recruiting
56
Research Site
Krefeld, Germany, 47805
Actively Recruiting
57
Research Site
Kulmbach, Germany, 95326
Actively Recruiting
58
Research Site
Landshut, Germany, 84036
Actively Recruiting
59
Research Site
Leer, Germany, 26789
Actively Recruiting
60
Research Site
Leipzig, Germany, 4103
Actively Recruiting
61
Research Site
Loerrach, Germany, 79539
Actively Recruiting
62
Research Site
Lübeck, Germany, 23562
Actively Recruiting
63
Research Site
Lüneburg, Germany, 21339
Actively Recruiting
64
Research Site
Magdeburg, Germany, 39130
Actively Recruiting
65
Research Site
Mainz, Germany, 55131
Actively Recruiting
66
Research Site
Marburg, Germany, 35037
Actively Recruiting
67
Research Site
Memmingen, Germany, 87700
Actively Recruiting
68
Research Site
Mönchengladbach, Germany, 41061
Actively Recruiting
69
Research Site
Mutlangen, Germany, 73557
Actively Recruiting
70
Research Site
Mühlhausen, Germany, 99974
Actively Recruiting
71
Research Site
München, Germany, 80638
Actively Recruiting
72
Research Site
München, Germany, 80639
Actively Recruiting
73
Research Site
München, Germany, 81377
Actively Recruiting
74
Research Site
Neumarkt, Germany, 92318
Withdrawn
75
Research Site
Neustadt am Rübenberge, Germany, 31535
Actively Recruiting
76
Research Site
Nordhausen, Germany, 99734
Actively Recruiting
77
Research Site
Nuremberg, Germany, 90419
Actively Recruiting
78
Research Site
Oldenburg, Germany, 26121
Actively Recruiting
79
Research Site
Oranienburg, Germany, 16515
Actively Recruiting
80
Research Site
Potsdam, Germany, 14467
Actively Recruiting
81
Research Site
Recklinghausen, Germany, 45659
Actively Recruiting
82
Research Site
Regensburg, Germany, 93053
Actively Recruiting
83
Research Site
Rosenheim, Germany, 83022
Actively Recruiting
84
Research Site
Rotenburg (Wümme), Germany, 27356
Actively Recruiting
85
Research Site
Saalfeld, Germany, 7318
Actively Recruiting
86
Research Site
Saarbrücken, Germany, 66113
Actively Recruiting
87
Research Site
Schwäbisch Hall, Germany, 74523
Actively Recruiting
88
Research Site
Siegen, Germany, 57072
Actively Recruiting
89
Research Site
Singen, Germany, 78224
Actively Recruiting
90
Research Site
Solingen, Germany, 42653
Actively Recruiting
91
Research Site
Stade, Germany, 21680
Actively Recruiting
92
Research Site
Stuttgart, Germany, 70199
Actively Recruiting
93
Research Site
Torgau, Germany, 4860
Actively Recruiting
94
Research Site
Troisdorf, Germany, 53840
Actively Recruiting
95
Research Site
Ulm, Germany, 89073
Actively Recruiting
96
Research Site
Walsrode, Germany, 29664
Actively Recruiting
97
Research Site
Weiden, Germany, 92637
Actively Recruiting
98
Research Site
Weinheim, Germany, 69469
Actively Recruiting
99
Research Site
Weißenfels, Germany, 6667
Actively Recruiting
100
Research Site
Westerstede, Germany, 26655
Actively Recruiting
101
Research Site
Wiesbaden, Germany, 65199
Actively Recruiting
102
Research Site
Winnenden, Germany, 71364
Actively Recruiting
103
Research Site
Witten, Germany, 58452
Actively Recruiting
104
Research Site
Wolfsburg, Germany, 38440
Actively Recruiting
105
Research Site
Wuppertal, Germany, 42283
Actively Recruiting
106
Research Site
Würzburg, Germany, 97080
Actively Recruiting
107
Research Site
Zittau, Germany, 02763
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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