Trial Title:
PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
NCT ID:
NCT05573893
Condition:
Breast Neoplasms
Breast Cancer
Neoplasm Metastasis
Conditions: Official terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Conditions: Keywords:
Trastuzumab-Deruxtecan,
Human epidermal growth factor receptor 2 Positive Breast Cancer,
Human epidermal growth factor receptor 2 Low Breast Cancer,
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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
unresectable or metastatic breast cancer (BC) and in patients with documented HER2-low
unresectable or metastatic 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 unresectable
or metastatic BC receiving T-DXd treatment or patients with documented HER2-low
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 cohort.
Criteria for eligibility:
Study pop:
Patients with documented Human epidermal growth factor receptor 2 (HER2)-positive
unresectable or metastatic breast cancer (BC) and patients with documented HER2-low
unresectable or metastatic BC receiving T-DXd in line with the applicable summary of
product characteristics (SmPC) within routine clinical practice may participate in this
NIS.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Adults ≥ 18 years old
2. Patients (irrespective of sex and gender) with pathologically documented breast
cancer that:
- is unresectable or metastatic
- has confirmed HER2+ or HER2-low 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 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.
3. Has documented radiologic progression (during or after most recent treatment)
4. Patient is eligible for T-DXd treatment in line with the specifications mentioned in
the ENHERTU® SmPC and is scheduled for T-DXd treatment *
5. Patient is able to read and understand either German or English
6. 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:
1. Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration
date)
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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Amberg
Zip:
92224
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ansbach
Zip:
91522
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Apolda
Zip:
99510
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Aschaffenburg
Zip:
63739
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Augsburg
Zip:
86150
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bad Reichenhall
Zip:
83435
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Baden-Baden
Zip:
76532
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beremerhaven
Zip:
27574
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
10715
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bielefeld
Zip:
33604
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bonn
Zip:
53111
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Brandenburg an der Havel
Zip:
14770
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Braunschweig
Zip:
38100
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bremen
Zip:
28209
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dessau
Zip:
6847
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Donauwoerth
Zip:
86609
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dortmund
Zip:
44137
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dresden
Zip:
1127
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Eggenfelden
Zip:
84307
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Erfurt
Zip:
99085
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Filderstadt - Bonlanden
Zip:
70794
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Frankfurt
Zip:
60389
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Freudenstadt
Zip:
72250
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fuerstenwalde
Zip:
15517
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gerlingen
Zip:
70839
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Giessen
Zip:
35392
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hamburg
Zip:
21073
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hannover
Zip:
30161
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hannover
Zip:
30449
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Heidenheim
Zip:
89522
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Heilbronn
Zip:
74078
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hildesheim
Zip:
31134
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Homburg/Saar
Zip:
66421
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Jena
Zip:
7747
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Karlsruhe
Zip:
76135
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kassel
Zip:
34117
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kassel
Zip:
34125
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kiel
Zip:
24116
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kulmbach
Zip:
95326
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Landshut
Zip:
84036
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Leer
Zip:
26789
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Leipzig
Zip:
4103
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Loerrach
Zip:
79539
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lüneburg
Zip:
21339
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Magdeburg
Zip:
39130
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mainz
Zip:
55131
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moenchengladbach
Zip:
41061
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Muenchen
Zip:
81377
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mutlangen
Zip:
73557
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mühlhausen
Zip:
99974
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Neumarkt
Zip:
92318
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Oldenburg
Zip:
26121
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Oranienburg
Zip:
16515
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Potsdam
Zip:
14467
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rosenheim
Zip:
83022
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rotenburg (Wuemme)
Zip:
27356
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saalfeld (Saale)
Zip:
7318
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saarbruecken
Zip:
66113
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Schwaebisch-Hall
Zip:
74523
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Singen
Zip:
78224
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Solingen
Zip:
42653
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Stade
Zip:
21680
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Stuttgart
Zip:
70199
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Torgau
Zip:
4860
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Troisdorf
Zip:
53840
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ulm
Zip:
89073
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Weinheim
Zip:
69469
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Weißenfels
Zip:
6667
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Westerstede
Zip:
26655
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wiesbaden
Zip:
65199
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Winnenden
Zip:
71364
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wuppertal
Zip:
42283
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Zittau
Zip:
02763
Country:
Germany
Status:
Recruiting
Start date:
September 12, 2023
Completion date:
December 31, 2031
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
Daiichi Sankyo
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05573893
