Actively Recruiting
PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
Led by West German Study Group · Updated on 2026-01-26
1470
Participants Needed
71
Research Sites
651 weeks
Total Duration
On this page
Sponsors
W
West German Study Group
Lead Sponsor
A
Agendia
Collaborating Sponsor
AI-Summary
What this Trial Is About
There is only limited data for premenopausal patients in general, as well as for differences in the use of OFS in the subgroups of pre- and perimenopausal patients, respectively. The WSG ADAPT trial data on the impact of postmenopausal status and/or use of OFS within 3-4 weeks endocrine induction therapy show relevant impact of OFS/postmenopausal status on Ki-67 response; also, secondary amenorrhea after (neo-)adjuvant chemotherapy was a positive predictor of outcome due to OFS \[8, 9\]. This registry will give insights in the real-world use of OFS and the effect of secondary amenorrhea in female pre- and perimenopausal patients with or without previous use of chemotherapy and with different endocrine treatments (ET +/- GnRH). As adherence over time (5-10 years) plays a major role in the endocrine treatment, the registry will follow patients' treatments for up to 10 years and include QoL information. Results of MammaPrint® (MammaPrint® Index) as indicating factor for chemotherapy use and risk classification, thus, choice of adjuvant treatment (chemotherapy, OFS combined with endocrine therapy, or endocrine therapy alone) will be correlated to outcome under real-world conditions. Baseline, treatment, and relapse data shall be collected to gain further insight in the treatment paths, treatment adherence, and outcome of such patients.
CONDITIONS
Official Title
PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female breast cancer patients
- Premenopausal or perimenopausal at registry entry (under 60 years old, with hysterectomy or amenorrhea less than 12 months; hormone levels confirming premenopausal status recommended)
- Primary tumor diagnosis within 3 months before inclusion (defined by initial tumor biopsy date)
- Estrogen- and/or progesterone-receptor-positive, HER2-negative early breast cancer without clinical signs of metastases
- Intermediate clinical risk for recurrence defined as: c/pT1, c/pN0, Ki-67 15-24%, or G2; or at investigator's discretion for intermediate risk
- High clinical risk for recurrence defined as: c/pT2-4, c/pN1, Ki-67 ≥25%, or G3
- Low genomic risk of recurrence by MammaPrint4 on treatment-na�ve tumor specimen
- Luminal-type by BluePrint4
- Planned or started standard-of-care treatment according to guidelines (including endocrine induction therapy or local therapy completion)
- Availability of untreated tumor material (core biopsy or surgery specimen)
- Ability to provide written informed consent
- Nodal positive patients allowed up to 25% of the genomic low/ultralow-risk population
You will not qualify if you...
- Any genomic testing on tumor material other than MammaPrint4
- Medical or psychological conditions preventing signing informed consent
- Legal incapacity or limited legal capacity
- Current participation in interventional clinical trials testing anticancer drugs, immunotherapeutics, or antibody treatments
- Patient non-compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 71 locations
1
Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum
Baden-Baden, Baden-Wurttemberg, Germany, 76532
Actively Recruiting
2
Helios Klinikum Pforzheim, Brustzentrum
Pforzheim, Baden-Wurttemberg, Germany, 75175
Actively Recruiting
3
Diakonieklinikum Stuttgart, Brustzetrum
Stuttgart, Baden-Wurttemberg, Germany, 70176
Active, Not Recruiting
4
Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe
Ulm, Baden-Wurttemberg, Germany, 89075
Actively Recruiting
5
GRN Klinik Weinheim/ Gynäkologie/Brustzentrum
Weinheim, Baden-Wurttemberg, Germany, 69469
Actively Recruiting
6
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, Baden-Wüttemberg, Germany, 76135
Actively Recruiting
7
Studienzentrum Onkologie Ravensburg
Ravensburg, Baden-Wüttemberg, Germany, 88212
Actively Recruiting
8
Klinikum St. Marien Amberg
Amberg, Bavaria, Germany, 9224
Actively Recruiting
9
HOP Gemeinschaftspraxis Dres. Heinrich/Bangerter, Augsburg
Augsburg, Bavaria, Germany, 86150
Actively Recruiting
10
Universitätsklinikum Augsburg, Brustzentrum
Augsburg, Bavaria, Germany, 86156
Actively Recruiting
11
Medias Klinikum
Burghausen, Bavaria, Germany, 84489
Active, Not Recruiting
12
Klinikum Fürstenfeldbruck, Westdeutsches Brust- Centrum
Fürstenfeldbruck, Bavaria, Germany, 82256
Actively Recruiting
13
Klinikum der Universität München
München, Bavaria, Germany, 80336
Actively Recruiting
14
Med. Zentrum f. Hämatologie und Onkologie München
München, Bavaria, Germany, 80639
Active, Not Recruiting
15
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde & Geburtshilfe
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
16
Gemeinschaftskrankenhaus/ Brustzentrum Havelhöhe
Berlin, Brandenburg, Germany, 14089
Actively Recruiting
17
Klinikum Luckenwalde
Luckenwalde, Brandenburg, Germany, 14943
Actively Recruiting
18
Klinikum Bremerhaven Reinkenheide
Bremerhaven, Free Hanseatic City of Bremen, Germany, 27574
Actively Recruiting
19
Gesundheitszentrum Wetterau gGmbH Hochwaldkrankenhaus Bad Nauheim
Bad Nauheim, Hesse, Germany, 61231
Actively Recruiting
20
Gynäkologische- Geburtshilfliche Klinik
Bad Soden am Taunus, Hesse, Germany, 65812
Actively Recruiting
21
Klinikum Hanau GmbH
Hanau, Hesse, Germany, 63450
Active, Not Recruiting
22
Elisabethkrankenhaus Kassel, Brustzentrum
Kassel, Hesse, Germany, 34117
Actively Recruiting
23
Universität Marburg, Klinik für Frauenheilkunde, Brustzentrum
Marburg, Hesse, Germany, 35043
Active, Not Recruiting
24
St. Josefs-Hospital Wiesbaden GmbH
Wiesbaden, Hesse, Germany, 65189
Actively Recruiting
25
DIAKOVERE Henriettenstift
Hanover, Lower Saxony, Germany, 30171
Actively Recruiting
26
Ärztehaus am Bahnhofsplatz
Hildesheim, Lower Saxony, Germany, 31134
Actively Recruiting
27
Studienzentrum Untere Ems
Leer, Lower Saxony, Germany, 26789
Actively Recruiting
28
Onkologische Praxis Oldenburg, Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie
Oldenburg, Lower Saxony, Germany, 26121
Actively Recruiting
29
Klinikum Südstadt
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Actively Recruiting
30
Marienhospital Aachen
Aachen, North Rhine-Westphalia, Germany, 52066
Actively Recruiting
31
Gynäkologisches Zentrum
Bonn, North Rhine-Westphalia, Germany, 53111
Active, Not Recruiting
32
Universitätsklinikum Bonn Frauenheilkunde
Bonn, North Rhine-Westphalia, Germany, 53127
Active, Not Recruiting
33
Universitätsklinikum Bonn, Senologie
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
34
Kliniken der Stadt Köln
Cologne, North Rhine-Westphalia, Germany, 51067
Actively Recruiting
35
St. Vincenz-Krankenhaus Datteln
Datteln, North Rhine-Westphalia, Germany, 45711
Actively Recruiting
36
Klinikum Dortmund gGmbH, Beurhausstr.40
Dortmund, North Rhine-Westphalia, Germany, 44137
Actively Recruiting
37
Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Brustzentrum
Duisburg, North Rhine-Westphalia, Germany, 47053
Actively Recruiting
38
Luisenkrankenhaus GmbH Co KG
Düsseldorf, North Rhine-Westphalia, Germany, 40235
Actively Recruiting
39
Marien Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40479
Actively Recruiting
40
Evang. Kliniken Essen Mitte, Interdisziplinäres Brustkrebszentrum
Essen, North Rhine-Westphalia, Germany, 45136
Actively Recruiting
41
St. Antonius Hospital Kleve (Katholisches Kral Leistner Zentrum)
Goch, North Rhine-Westphalia, Germany, 47574
Active, Not Recruiting
42
AGAPLESION Allgemeines Krankenhaus Hagen
Hagen, North Rhine-Westphalia, Germany, 58095
Actively Recruiting
43
St. Barbara Klinik
Hamm, North Rhine-Westphalia, Germany, 59073
Actively Recruiting
44
Gemeinschaftskrankenhaus Herdecke gemeinnützige GmbH
Herdecke, North Rhine-Westphalia, Germany, 58313
Actively Recruiting
45
Klinikum Leverkusen, Am Gesundheitspark
Leverkusen, North Rhine-Westphalia, Germany, 51375
Active, Not Recruiting
46
Katholisches Klinikum Lünen/Werne
Lünen, North Rhine-Westphalia, Germany, 44534
Actively Recruiting
47
Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus
Mönchengladbach, North Rhine-Westphalia, Germany, 41061
Actively Recruiting
48
St. Franziskus-Hospital
Münster, North Rhine-Westphalia, Germany, 48145
Actively Recruiting
49
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
50
Frauenklinik St. Louise - St. Vincenz-Krankenhaus GmbH
Paderborn, North Rhine-Westphalia, Germany, 33098
Actively Recruiting
51
Mathias-Spital-Rheine
Rheine, North Rhine-Westphalia, Germany, 48431
Actively Recruiting
52
Praxisnetzwerk Hämatologie/int. Onkologie
Troisdorf, North Rhine-Westphalia, Germany, 53840
Actively Recruiting
53
Christliches Klinikum Unna gGmbH
Unna, North Rhine-Westphalia, Germany, 59423
Actively Recruiting
54
Evangelisches Krankenhaus Wesel GmbH
Wesel, North Rhine-Westphalia, Germany, 46485
Actively Recruiting
55
Helios Klinikum Wuppertal
Wuppertal, North Rhine-Westphalia, Germany, 42283
Actively Recruiting
56
Klinikum Worms
Worms, Rhineland-Palatinate, Germany, 67550
Actively Recruiting
57
Krankenhaus St. Elisabeth und St. Barbara Halle/Saale
Halle, Saxony-Anhalt, Germany, 06110
Actively Recruiting
58
Altmark- Klinikum
Hansestadt Salzwedel, Saxony-Anhalt, Germany, 29410
Actively Recruiting
59
Medionko - Praxisklinik Krebsheilkunde Frauen
Berlin, Germany, 10367
Active, Not Recruiting
60
St. Gertrauden Krankenhaus Brustzentrum City Berlin
Berlin, Germany, 10713
Actively Recruiting
61
DRK Kliniken Berlin Köpenick
Berlin, Germany, 12559
Actively Recruiting
62
Marienhospital, Klinik für Gynäkologie und Geburtshilfe
Bottrop, Germany
Actively Recruiting
63
Hämatologie/Onkologie Praxis
Bremen, Germany, 28209
Actively Recruiting
64
DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
Bremen, Germany, 28239
Actively Recruiting
65
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Active, Not Recruiting
66
AGAPLESION Diakonie Hamburg
Hamburg, Germany, 20259
Actively Recruiting
67
Gynäkologische Praxisklinik Hamburg-Harburg
Hamburg, Germany, 21073
Actively Recruiting
68
Asklepios Klinik Barmbek
Hamburg, Germany, 22307
Actively Recruiting
69
Helios Klinikum Krefeld, Zentrum für Ambulante Gynäkologische Onkologie - Studienabteilung
Krefeld, Germany
Actively Recruiting
70
MKS St. Paulus Schwerte (ehemals Marienkrankenhaus)
Schwerte, Germany
Active, Not Recruiting
71
Klinikum Traunstein, Frauenklinik Südostbayern
Traunstein, Germany
Actively Recruiting
Research Team
J
Julian Moellers
CONTACT
A
Anja Braschoss, MD
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
0
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