AzTrials
AzTrials

Female Breast CancerPROOFSNCT05792150

PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS

An observational study of Female Breast Cancer, run by Women's Cancer Study Group GmbH at 71 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Female Breast Cancer
How many people
1,470 participants
Where
71 sitesGermany
Study dates
7 Dec 2022to Jun 2035
How long will I take part?
10 Years
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 60 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: For this registry, it is planned to screen N=3000 pre- and perimenopausal patients with early breast cancer who meet the inclusion criteria, i.e., intermediate to high clinical risk for recurrence, and who will receive or have received a routine genomic testing by MammaPrint® with a low/ultralow genomic risk. It is anticipated that 75% of these patients will be nodal negative and 25% nodal positive.

Who may be able to join

  • Patients are eligible for participation in the registry only if they meet all the following criteria:
  • Female breast cancer patients
  • Pre- or perimenopausal at registry entry (age <60 years and state after hysterectomy or amenorrhea for <12 months; confirmation by blood hormone levels (FSH and estradiol in premenopausal range as per local normal range) recommended)
  • Primary tumor diagnosis not older than three months prior to inclusion (primary diagnosis defined as date of initial tumor biopsy)
  • Estrogen- and/or progesterone-receptor-positive/HER2 negative early breast cancer without any clinical signs of metastases
  • Adequate risk for recurrence:
Show all 23Show fewer
  • intermediate clinical risk for recurrence, defined as (clinical in case of neoadjuvant treatment):
  • c/pT1 and
  • c/pN0 and
  • Ki-67 15-24% or
  • G2 or
  • patients, who do not meet these criteria but are at intermediate clinical risk for recurrence at investigator decision (e.g., very young age, low expression of hormone receptors, existing co-morbidities, familial cancer burden, etc.) can be included on individual decision basis or
  • high clinical risk for recurrence, defined as either (clinical in case of neoadjuvant treatment):
  • c/pT2-4 or
  • c/pN1 or
  • Ki-67 ≥25% or
  • G3
  • Low genomic risk of recurrence by MammaPrint® (tested on treatment naïve tumor specimen)
  • Luminal-type by BluePrint®
  • Treatment according to standard-of-care (e.g., AGO Guidelines) planned or started (until completion of local therapy the latest (including started or completed endocrine induction therapy), started, or planned adjuvant or neoadjuvant treatment)
  • Availability of untreated tumor material (core biopsy if preoperative endocrine therapy performed or neoadjuvant treatment intended or surgery specimen)
  • Capability to give written informed consent
  • Nodal positive patients will be accepted to the registry up to 25% of the genomic low/ultralow-risk population (n=441).

Who cannot join

  • Patients will not be eligible for the registry for any of the following reasons:
  • Any other genomic testing, besides MammaPrint®, has been performed on the tumor material
  • Medical or psychological conditions that would not permit the patient to sign informed consent
  • Legal incapacity or limited legal capacity
  • Current participation in any interventional clinical trial which tests anticancer drugs, immunotherapeutics, or antibody treatment for any type of neoplasm
  • Non-compliance of the patient

Trial locations and contacts

71 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Julian Moellers contact

00492161566 23-0

julian.moellers@wsg-online.com

Anja Braschoss, MD contact

04917682119153

anja.braschoss@wsg-online.com

71 sites in 1 country

Germany71 sites, 61 recruiting

  • Marienhospital Aachen

    Aachen, North Rhine-Westphalia, 52066

    Esther Geller, Dr. med.

    Birgit Dreyer

    Recruiting

  • Klinikum St. Marien Amberg

    Amberg, Bavaria, 9224

    Tanja Hauzenberger, Dr. med

    Jacqueline Roy

    Recruiting

  • HOP Gemeinschaftspraxis Dres. Heinrich/Bangerter, Augsburg

    Augsburg, Bavaria, 86150

    Bernhard Heinrich, Dr. med.

    Karin Hillgardt

    Recruiting

  • Universitätsklinikum Augsburg, Brustzentrum

    Augsburg, Bavaria, 86156

    Nina Ditsch, Prof. Dr.

    Sonja Dannecker

    Recruiting

  • Gesundheitszentrum Wetterau gGmbH Hochwaldkrankenhaus Bad Nauheim

    Bad Nauheim, Hesse, 61231

    Martin Hellriegel, Dr. med.

    Anne Groß

    Recruiting

  • Gynäkologische- Geburtshilfliche Klinik

    Bad Soden am Taunus, Hesse, 65812

    Johannes Lecht, Dr.

    Susanne Hegner, Dpl.

    Recruiting

  • Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum

    Baden-Baden, Baden-Wurttemberg, 76532

    Antje Hahn, Dr. med.

    Martina Koch

    Recruiting

  • Gemeinschaftskrankenhaus/ Brustzentrum Havelhöhe

    Berlin, Brandenburg, 14089

    Jessica Groß, Dr

    Antje Merkle

    Recruiting

  • Medionko - Praxisklinik Krebsheilkunde Frauen

    Berlin, State of Berlin, 10367

    Active, not recruiting

  • St. Gertrauden Krankenhaus Brustzentrum City Berlin

    Berlin, State of Berlin, 10713

    Lidia Perlova-Griff

    Michaela Platzer

    Recruiting

  • DRK Kliniken Berlin Köpenick

    Berlin, State of Berlin, 12559

    Anke Kleine-Tebbe, Dr. med.

    Manuela Rösler

    Recruiting

  • Gynäkologisches Zentrum

    Bonn, North Rhine-Westphalia, 53111

    Active, not recruiting

  • Universitätsklinikum Bonn Frauenheilkunde

    Bonn, North Rhine-Westphalia, 53127

    Active, not recruiting

  • Universitätsklinikum Bonn, Senologie

    Bonn, North Rhine-Westphalia, 53127

    Anne Bachmann

    Judith Sailler

    Recruiting

  • Marienhospital, Klinik für Gynäkologie und Geburtshilfe

    Bottrop

    Hans-Christian Kolberg, PD Dr.

    Jessica Zeller

    Recruiting

  • Hämatologie/Onkologie Praxis

    Bremen, Free Hanseatic City of Bremen, 28209

    Ralf Meyer, Dr. med.

    Heike Munzinger, Dr. nat.

    Recruiting

  • DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

    Bremen, Free Hanseatic City of Bremen, 28239

    Barbara Baloniak, Dr.

    Monika Tietze

    Recruiting

  • Klinikum Bremerhaven Reinkenheide

    Bremerhaven, Free Hanseatic City of Bremen, 27574

    Amelie Bletscher

    Marcelle Lagemann

    Recruiting

  • Medias Klinikum

    Burghausen, Bavaria, 84489

    Active, not recruiting

  • Kliniken der Stadt Köln

    Cologne, North Rhine-Westphalia, 51067

    Katharina Weinhold, Dr. med.

    Claudia Weise

    Recruiting

  • St. Vincenz-Krankenhaus Datteln

    Datteln, North Rhine-Westphalia, 45711

    Saskia Hornberg, Dr.

    Silvia Schneider

    Recruiting

  • Klinikum Dortmund gGmbH, Beurhausstr.40

    Dortmund, North Rhine-Westphalia, 44137

    Claudia Biehl

    Jacqueline Aschhoff

    Recruiting

  • Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Brustzentrum

    Duisburg, North Rhine-Westphalia, 47053

    Katja Engellandt, Dr. med.

    Antje auf dem Keller

    Recruiting

  • Luisenkrankenhaus GmbH Co KG

    Düsseldorf, North Rhine-Westphalia, 40235

    Athina Kostara, Dr. med.

    Anne Huelsewiesche

    Recruiting

  • Marien Hospital Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40479

    Jens-Peter Kruse

    David Tschirch

    Recruiting

  • Universitätsklinikum Erlangen

    Erlangen, Erlangen, 91054

    Active, not recruiting

  • Evang. Kliniken Essen Mitte, Interdisziplinäres Brustkrebszentrum

    Essen, North Rhine-Westphalia, 45136

    Sherko Kümmel, Prof.Dr

    Dorothea Schindowski

    Recruiting

  • Klinikum Fürstenfeldbruck, Westdeutsches Brust- Centrum

    Fürstenfeldbruck, Bavaria, 82256

    Konstanze Türpe

    Mandy Merwerth

    Recruiting

  • St. Antonius Hospital Kleve (Katholisches Kral Leistner Zentrum)

    Goch, North Rhine-Westphalia, 47574

    Volker Runde, Prof. Dr.

    Elke Beeker-Cornelissen

    Recruiting

  • AGAPLESION Allgemeines Krankenhaus Hagen

    Hagen, North Rhine-Westphalia, 58095

    Nurhayat Yurtcu, Dr.

    Tamara Sitnikow

    Recruiting

  • Krankenhaus St. Elisabeth und St. Barbara Halle/Saale

    Halle, Saxony-Anhalt, 06110

    Tilmann Lantzsch, Dr. med.

    Mandy Babbe

    Recruiting

  • AGAPLESION Diakonie Hamburg

    Hamburg, Free and Hanseatic City of Hamburg, 20259

    Mustafa Celalettin Ugur, Dr.

    Mirjam Ahrens

    Recruiting

  • Gynäkologische Praxisklinik Hamburg-Harburg

    Hamburg, Free and Hanseatic City of Hamburg, 21073

    Christoph Großmann, Dr. med.

    Belma Salihadgic

    Recruiting

  • Asklepios Klinik Barmbek

    Hamburg, Free and Hanseatic City of Hamburg, 22307

    Katharina Maria Seiffert, Dr.med.

    Sabine Drießelmann

    Recruiting

  • St. Barbara Klinik

    Hamm, North Rhine-Westphalia, 59073

    Claudia Strunk, Dr.

    Gabriele Kerkmann

    Recruiting

  • Klinikum Hanau GmbH

    Hanau, Hesse, 63450

    Active, not recruiting

  • DIAKOVERE Henriettenstift

    Hanover, Lower Saxony, 30171

    Kristina Lübbe, Dr.

    Laura Alina Löffler

    Recruiting

  • Altmark- Klinikum

    Hansestadt Salzwedel, Saxony-Anhalt, 29410

    Susanne Kraudelt, Dr.

    Steffi Mack-Eichner

    Recruiting

  • Gemeinschaftskrankenhaus Herdecke gemeinnützige GmbH

    Herdecke, North Rhine-Westphalia, 58313

    Hanne- Kathrin Bracht

    Jasmin Schiprowski

    Recruiting

  • Ärztehaus am Bahnhofsplatz

    Hildesheim, Lower Saxony, 31134

    Christopher Uleer, Dr.

    Andrea Meyer-Kühn

    Recruiting

  • ViDia Christliche Kliniken Karlsruhe

    Karlsruhe, Baden-Wüttemberg, 76135

    Oliver Tomé, Dr.

    Recruiting

  • Elisabethkrankenhaus Kassel, Brustzentrum

    Kassel, Hesse, 34117

    Sabine Schmatloch, Dr. med.

    Ivonne Kurzhals

    Recruiting

  • Helios Klinikum Krefeld, Zentrum für Ambulante Gynäkologische Onkologie - Studienabteilung

    Krefeld

    Maria Marina Wirtz, Dr. med.

    Laura Mengel

    Recruiting

  • Studienzentrum Untere Ems

    Leer, Lower Saxony, 26789

    Lothar Müller, Dr. med

    Christine Strohschnieder

    Recruiting

  • Klinikum Leverkusen, Am Gesundheitspark

    Leverkusen, North Rhine-Westphalia, 51375

    Andrea Heider, Dr.

    Katja Pöggel-Krämer

    Recruiting

  • Klinikum Luckenwalde

    Luckenwalde, Brandenburg, 14943

    Benedikt Lotz, Dr

    Orfea-Graziella Zehm

    Recruiting

  • Katholisches Klinikum Lünen/Werne

    Lünen, North Rhine-Westphalia, 44534

    Donat Romann, Dr.

    Ute Heine

    Recruiting

  • Universität Marburg, Klinik für Frauenheilkunde, Brustzentrum

    Marburg, Hesse, 35043

    Active, not recruiting

  • Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus

    Mönchengladbach, North Rhine-Westphalia, 41061

    Oleg Gluz, PD Dr.

    Carolin Sydlik

    Recruiting

  • Klinikum der Universität München

    München, Bavaria, 80336

    Nadia Harbeck, Prof. Dr.

    Beate Rank

    Recruiting

  • Med. Zentrum f. Hämatologie und Onkologie München

    München, Bavaria, 80639

    Active, not recruiting

  • St. Franziskus-Hospital

    Münster, North Rhine-Westphalia, 48145

    Christian Eichler, PD Dr.

    Sarah Damerau

    Recruiting

  • Universitaetsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149

    Joke Tio, Dr.

    Stefanie Nienkemper

    Recruiting

  • Onkologische Praxis Oldenburg, Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie

    Oldenburg, Lower Saxony, 26121

    Daniel Reschke, Dr.

    Antje Reschke

    Recruiting

  • Frauenklinik St. Louise - St. Vincenz-Krankenhaus GmbH

    Paderborn, North Rhine-Westphalia, 33098

    Michael-Patrick Lux, Prof. Dr.

    Sara Heimann

    Recruiting

  • Helios Klinikum Pforzheim, Brustzentrum

    Pforzheim, Baden-Wurttemberg, 75175

    Renu Buss-Steidle, Dr.

    Dana Ruppert

    Recruiting

  • Studienzentrum Onkologie Ravensburg

    Ravensburg, Baden-Wüttemberg, 88212

    Thomas Decker, Prof. Dr.med

    Irina Gossen

    Recruiting

  • Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde & Geburtshilfe

    Regensburg, Bavaria, 93053

    Stephan Seitz, Dr.

    Cornelia Lämmel

    Recruiting

  • Mathias-Spital-Rheine

    Rheine, North Rhine-Westphalia, 48431

    Sebastian Bröckling, Dr. med.

    Denise Ernst

    Recruiting

  • Klinikum Südstadt

    Rostock, Mecklenburg-Vorpommern, 18059

    Kristin Strauß, Dr.

    Michaela Stecher

    Recruiting

  • MKS St. Paulus Schwerte (ehemals Marienkrankenhaus)

    Schwerte

    Active, not recruiting

  • Diakonieklinikum Stuttgart, Brustzetrum

    Stuttgart, Baden-Wurttemberg, 70176

    Active, not recruiting

  • Klinikum Traunstein, Frauenklinik Südostbayern

    Traunstein

    Christian Schindlbeck, Prof. Dr.

    Christina Greil

    Recruiting

  • Praxisnetzwerk Hämatologie/int. Onkologie

    Troisdorf, North Rhine-Westphalia, 53840

    Helmut Forstbauer, Dr. med.

    Stefanie Vorpahl

    Recruiting

  • Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe

    Ulm, Baden-Wurttemberg, 89075

    Brigitte Rack, Prof. Dr.

    Mirela Karic

    Recruiting

  • Christliches Klinikum Unna gGmbH

    Unna, North Rhine-Westphalia, 59423

    Cristin Kühn, Dr. med.

    Vanessa Schuster

    Recruiting

  • GRN Klinik Weinheim/ Gynäkologie/Brustzentrum

    Weinheim, Baden-Wurttemberg, 69469

    Lelia Bauer, Dr. med.

    Snjezana Stein

    Recruiting

  • Evangelisches Krankenhaus Wesel GmbH

    Wesel, North Rhine-Westphalia, 46485

    Daniela Rezek, Dr. med.

    Shqipe Lorito

    Recruiting

  • St. Josefs-Hospital Wiesbaden GmbH

    Wiesbaden, Hesse, 65189

    Antje Lehnert, Dr. med.

    Andrea Lunkenheimer

    Recruiting

  • Klinikum Worms

    Worms, Rhineland-Palatinate, 67550

    Antje Nixdorf, Dr. med.

    Tanja Knoll

    Recruiting

  • Helios Klinikum Wuppertal

    Wuppertal, North Rhine-Westphalia, 42283

    Vesna Bjelic-Radisic, Prof. Dr.

    Manuela Smiljanic

    Recruiting

Other trials in Germany

About this study

Official title: Real World Data and Long-term FU of Pre-/Perimenopausal Women With Luminal EBC With Intermediate to High Clinical and Low Genomic Recurrence-risk Measured by MammaPrint®, Treated by SOC ET+OFS or SOC Chemotherapy Treatment Followed by ET

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).

Read more

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.

Read the detailed description

This registry aims

  • to confirm an excellent outcome in pre-/perimenopausal patients treated by endocrine therapy (+ ovarian suppression) in patients with low genomic risk by MammaPrint® without chemotherapy use in a real-world setting.
  • to evaluate management of ovarian function in patients treated by adjuvant chemotherapy according to investigator decision.
  • to evaluate adherence to endocrine therapy (+/- ovarian function suppression).
  • to evaluate the prognostic impact of clinicopathological markers (e.g., estrogen receptor (ER), progesterone receptor (PR), HER2 receptor, Ki-67 at baseline and after preoperative endocrine therapy (if any performed) by local pathology assessment compared to genomic signature result.
  • to assess the course of quality of life (QLQ BR23 and QLQ-C30) until 5 years of treatment with OFS (Baseline, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years)

In general, WSG aim to assess the quality of surveillance care in younger breast cancer patients. WSG want to gain knowledge about endocrine induction treatment for indication of chemotherapy followed by endocrine treatment or endocrine treatment alone. Also, WSG aim at changes in duration of endocrine treatment (especially in high-risk patients up to 10 years) and introduction of intensified endocrine therapy (OFS) in combination with GnRH-analogues since publication of the SOFT and TEXT trials.

Keywords
HR+, HER2-, EBC, early breast cancer, female, OFS, ET, chemotherapy
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5-year distant recurrence-free interval (dRFI, according to STEEP criteria version 2.0)

    dRFIin all patients treated by (intensified) endocrine therapy alone (and with ovarian suppression in cases with enhanced clinical risk according to current AGO-recommendations)

    Measured: 5 years

Secondary outcomes (20)

  1. 10-year dRFI

    dRFI, according to STEEP criteria 2.0, in all patients treated by (intensified) endocrine therapy alone (with ovarian suppression in cases with higher clinical risk)

    Measured: 10 years

  2. 5-year dRFI

    dRFI, according to STEEP criteria 2.0,in all patients treated by SOC chemotherapy treatment followed by ET+/-OFS

    Measured: 5 years

  3. 10-year dRFI

    dRFI, according to STEEP criteria 2.0,in all patients treated by SOC chemotherapy treatment followed by ET+/-OFS

    Measured: 10 years

  4. 5-year dDFS

    distant disease-free survival (dDFS, according to STEEP 2.0) in all patients and all treatment groups (i.e., patients treated by ET alone, ET + GnRH, chemotherapy followed by ET, chemotherapy followed by ET + GnRH, OFS-treated patients)

    Measured: 5 years

  5. 10-year dDFS

    distant disease-free survival (dDFS, according to STEEP 2.0) in all patients and all treatment groups (i.e., patients treated by ET alone, ET + GnRH, chemotherapy followed by ET, chemotherapy followed by ET + GnRH, OFS-treated patients)treatment followed by ET+/-OFS

    Measured: 10 years

  6. 5-year OS

    overall survival (OS) in all patients and all treatment groups

    Measured: 5 years

  7. 10-year OS

    overall survival (OS) in all patients and all treatment groups

    Measured: 10 years

  8. 5-year breast cancer-free interval (BCFI, according to STEEP 2.0)

    BCFI in all patients and all treatment groups

    Measured: 5 years

  9. 10-year breast cancer-free interval (BCFI, according to STEEP 2.0)

    BCFI in all patients and all treatment groups

    Measured: 10 years

  10. EORTC quality of life questionnaire BR23

    compare the course of Qol between baseline and further defined timepoints; 23 items, symptom scales/items and functional scales/items, all of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.

    Measured: every 3 months within 1st year

  11. EORTC quality of life questionnaire C30

    compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.

    Measured: every 3 months within 1st year

  12. EORTC quality of life questionnaire BR23

    compare the course of Qol between baseline and further defined timepoints; 23 items, symptom scales/items and functional scales/items, all of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.

    Measured: every 6 months within 2nd year

  13. EORTC quality of life questionnaire C30

    compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.

    Measured: every 6 months within 2nd year

  14. EORTC quality of life questionnaire BR23

    compare the course of Qol between baseline and further defined timepoints; 23 items, symptom scales/items and functional scales/items, all of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.

    Measured: yearly until 5 years

  15. EORTC quality of life questionnaire C30

    compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.

    Measured: yearly until 5 years

  16. adherence to OFS and endocrine treatment

    Duration of intake of OFS and endocrine treatment in all patients

    Measured: 10 years

  17. concordance between BluePrint®/MammaPrint® molecular subtyping results vs. pathological immune-histochemistry results

    concordance between BluePrint®/MammaPrint® molecular subtyping results and pathological immune-histochemistry results with respect to tumour type

    Measured: 10 years

  18. endocrine response measured by post-endocrine Ki-67

    post-endocrine Ki-67 (≤10% and/or relative change vs. baseline) in patients treated by preoperative ET

    Measured: 10 years

  19. 5-year iDFS in node-negative patients with ultralow MammaPrint

    node-negative patients with ultralow MammaPrint® treated by shorter duration of ET (2-3 years at investigator decision)

    Measured: 5 years

  20. 10-year iDFS in node-negative patients with ultralow MammaPrint

    node-negative patients with ultralow MammaPrint® treated by shorter duration of ET (2-3 years at investigator decision)

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2023
  2. Study start7 Dec 2022
  3. Primary completionMar 2035 (estimated)
  4. Study completionJun 2035 (estimated)

Resources

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
1,470 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05792150
Sponsor's protocol ID
WSG-NIS04 / PROOFS
Acronym
PROOFS
Status last verified
Aug 2026
First submitted
13 Feb 2023
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Female Breast Cancer, run by Women's Cancer Study Group GmbH at 71 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 23 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 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 Julian Moellers (00492161566 23-0, julian.moellers@wsg-online.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-year distant recurrence-free interval (dRFI, according to STEEP criteria version 2.0) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05792150.

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 5 Aug 2026.

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