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

August 4, 2026 updated by: Women's Cancer Study Group GmbH

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).

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1470

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Bottrop, Germany
        • Recruiting
        • Marienhospital, Klinik für Gynäkologie und Geburtshilfe
        • Contact:
          • Hans-Christian Kolberg, PD Dr.
        • Contact:
          • Jessica Zeller
      • Krefeld, Germany
        • Recruiting
        • Helios Klinikum Krefeld, Zentrum für Ambulante Gynäkologische Onkologie - Studienabteilung
        • Contact:
          • Laura Mengel
        • Contact:
          • Maria Marina Wirtz, Dr. med.
      • Schwerte, Germany
        • Active, not recruiting
        • MKS St. Paulus Schwerte (ehemals Marienkrankenhaus)
      • Traunstein, Germany
        • Recruiting
        • Klinikum Traunstein, Frauenklinik Südostbayern
        • Contact:
          • Christian Schindlbeck, Prof. Dr.
        • Contact:
          • Christina Greil
    • Baden-Wurttemberg
      • Baden-Baden, Baden-Wurttemberg, Germany, 76532
        • Recruiting
        • Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum
        • Contact:
          • Martina Koch
        • Contact:
          • Antje Hahn, Dr. med.
      • Pforzheim, Baden-Wurttemberg, Germany, 75175
        • Recruiting
        • Helios Klinikum Pforzheim, Brustzentrum
        • Contact:
          • Renu Buss-Steidle, Dr.
        • Contact:
          • Dana Ruppert
      • Stuttgart, Baden-Wurttemberg, Germany, 70176
        • Active, not recruiting
        • Diakonieklinikum Stuttgart, Brustzetrum
      • Ulm, Baden-Wurttemberg, Germany, 89075
        • Recruiting
        • Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe
        • Contact:
          • Brigitte Rack, Prof. Dr.
        • Contact:
          • Mirela Karic
      • Weinheim, Baden-Wurttemberg, Germany, 69469
        • Recruiting
        • GRN Klinik Weinheim/ Gynäkologie/Brustzentrum
        • Contact:
          • Lelia Bauer, Dr. med.
        • Contact:
          • Snjezana Stein
    • Baden-Wüttemberg
      • Karlsruhe, Baden-Wüttemberg, Germany, 76135
        • Recruiting
        • ViDia Christliche Kliniken Karlsruhe
        • Contact:
          • Oliver Tomé, Dr.
      • Ravensburg, Baden-Wüttemberg, Germany, 88212
        • Recruiting
        • Studienzentrum Onkologie Ravensburg
        • Contact:
          • Thomas Decker, Prof. Dr.med
        • Contact:
          • Irina Gossen
    • Bavaria
      • Amberg, Bavaria, Germany, 9224
        • Recruiting
        • Klinikum St. Marien Amberg
        • Contact:
          • Tanja Hauzenberger, Dr. med
        • Contact:
          • Jacqueline Roy
      • Augsburg, Bavaria, Germany, 86150
        • Recruiting
        • HOP Gemeinschaftspraxis Dres. Heinrich/Bangerter, Augsburg
        • Contact:
          • Bernhard Heinrich, Dr. med.
        • Contact:
          • Karin Hillgardt
      • Augsburg, Bavaria, Germany, 86156
        • Recruiting
        • Universitätsklinikum Augsburg, Brustzentrum
        • Contact:
          • Nina Ditsch, Prof. Dr.
        • Contact:
          • Sonja Dannecker
      • Burghausen, Bavaria, Germany, 84489
        • Active, not recruiting
        • Medias Klinikum
      • Fürstenfeldbruck, Bavaria, Germany, 82256
        • Recruiting
        • Klinikum Fürstenfeldbruck, Westdeutsches Brust- Centrum
        • Contact:
          • Konstanze Türpe
        • Contact:
          • Mandy Merwerth
      • München, Bavaria, Germany, 80336
        • Recruiting
        • Klinikum der Universität München
        • Contact:
          • Nadia Harbeck, Prof. Dr.
        • Contact:
          • Beate Rank
      • München, Bavaria, Germany, 80639
        • Active, not recruiting
        • Med. Zentrum f. Hämatologie und Onkologie München
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde & Geburtshilfe
        • Contact:
          • Stephan Seitz, Dr.
        • Contact:
          • Cornelia Lämmel
    • Brandenburg
      • Berlin, Brandenburg, Germany, 14089
        • Recruiting
        • Gemeinschaftskrankenhaus/ Brustzentrum Havelhöhe
        • Contact:
          • Jessica Groß, Dr
        • Contact:
          • Antje Merkle
      • Luckenwalde, Brandenburg, Germany, 14943
        • Recruiting
        • Klinikum Luckenwalde
        • Contact:
          • Benedikt Lotz, Dr
        • Contact:
          • Orfea-Graziella Zehm
    • Erlangen
      • Erlangen, Erlangen, Germany, 91054
        • Active, not recruiting
        • Universitätsklinikum Erlangen
    • Free Hanseatic City of Bremen
      • Bremen, Free Hanseatic City of Bremen, Germany, 28209
        • Recruiting
        • Hämatologie/Onkologie Praxis
        • Contact:
          • Ralf Meyer, Dr. med.
        • Contact:
          • Heike Munzinger, Dr. nat.
      • Bremen, Free Hanseatic City of Bremen, Germany, 28239
        • Recruiting
        • DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
        • Contact:
          • Barbara Baloniak, Dr.
        • Contact:
          • Monika Tietze
      • Bremerhaven, Free Hanseatic City of Bremen, Germany, 27574
        • Recruiting
        • Klinikum Bremerhaven Reinkenheide
        • Contact:
          • Amelie Bletscher
        • Contact:
          • Marcelle Lagemann
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20259
        • Recruiting
        • AGAPLESION Diakonie Hamburg
        • Contact:
          • Mustafa Celalettin Ugur, Dr.
        • Contact:
          • Mirjam Ahrens
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 21073
        • Recruiting
        • Gynäkologische Praxisklinik Hamburg-Harburg
        • Contact:
          • Christoph Großmann, Dr. med.
        • Contact:
          • Belma Salihadgic
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 22307
        • Recruiting
        • Asklepios Klinik Barmbek
        • Contact:
          • Katharina Maria Seiffert, Dr.med.
        • Contact:
          • Sabine Drießelmann
    • Hesse
      • Bad Nauheim, Hesse, Germany, 61231
        • Recruiting
        • Gesundheitszentrum Wetterau gGmbH Hochwaldkrankenhaus Bad Nauheim
        • Contact:
          • Martin Hellriegel, Dr. med.
        • Contact:
          • Anne Groß
      • Bad Soden am Taunus, Hesse, Germany, 65812
        • Recruiting
        • Gynäkologische- Geburtshilfliche Klinik
        • Contact:
          • Johannes Lecht, Dr.
        • Contact:
          • Susanne Hegner, Dpl.
      • Hanau, Hesse, Germany, 63450
        • Active, not recruiting
        • Klinikum Hanau GmbH
      • Kassel, Hesse, Germany, 34117
        • Recruiting
        • Elisabethkrankenhaus Kassel, Brustzentrum
        • Contact:
          • Sabine Schmatloch, Dr. med.
        • Contact:
          • Ivonne Kurzhals
      • Marburg, Hesse, Germany, 35043
        • Active, not recruiting
        • Universität Marburg, Klinik für Frauenheilkunde, Brustzentrum
      • Wiesbaden, Hesse, Germany, 65189
        • Recruiting
        • St. Josefs-Hospital Wiesbaden GmbH
        • Contact:
          • Antje Lehnert, Dr. med.
        • Contact:
          • Andrea Lunkenheimer
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30171
        • Recruiting
        • DIAKOVERE Henriettenstift
        • Contact:
          • Kristina Lübbe, Dr.
        • Contact:
          • Laura Alina Löffler
      • Hildesheim, Lower Saxony, Germany, 31134
        • Recruiting
        • Ärztehaus am Bahnhofsplatz
        • Contact:
          • Christopher Uleer, Dr.
        • Contact:
          • Andrea Meyer-Kühn
      • Leer, Lower Saxony, Germany, 26789
        • Recruiting
        • Studienzentrum Untere Ems
        • Contact:
          • Christine Strohschnieder
        • Contact:
          • Lothar Müller, Dr. med
      • Oldenburg, Lower Saxony, Germany, 26121
        • Recruiting
        • Onkologische Praxis Oldenburg, Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie
        • Contact:
          • Daniel Reschke, Dr.
        • Contact:
          • Antje Reschke
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • Recruiting
        • Klinikum Südstadt
        • Contact:
          • Michaela Stecher
        • Contact:
          • Kristin Strauß, Dr.
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52066
        • Recruiting
        • Marienhospital Aachen
        • Contact:
          • Birgit Dreyer
        • Contact:
          • Esther Geller, Dr. med.
      • Bonn, North Rhine-Westphalia, Germany, 53111
        • Active, not recruiting
        • Gynäkologisches Zentrum
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Active, not recruiting
        • Universitätsklinikum Bonn Frauenheilkunde
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Recruiting
        • Universitätsklinikum Bonn, Senologie
        • Contact:
          • Anne Bachmann
        • Contact:
          • Judith Sailler
      • Cologne, North Rhine-Westphalia, Germany, 51067
        • Recruiting
        • Kliniken der Stadt Koln
        • Contact:
          • Claudia Weise
        • Contact:
          • Katharina Weinhold, Dr. med.
      • Datteln, North Rhine-Westphalia, Germany, 45711
        • Recruiting
        • St. Vincenz-Krankenhaus Datteln
        • Contact:
          • Silvia Schneider
        • Contact:
          • Saskia Hornberg, Dr.
      • Dortmund, North Rhine-Westphalia, Germany, 44137
        • Recruiting
        • Klinikum Dortmund gGmbH, Beurhausstr.40
        • Contact:
          • Claudia Biehl
        • Contact:
          • Jacqueline Aschhoff
      • Duisburg, North Rhine-Westphalia, Germany, 47053
        • Recruiting
        • Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Brustzentrum
        • Contact:
          • Katja Engellandt, Dr. med.
        • Contact:
          • Antje auf dem Keller
      • Düsseldorf, North Rhine-Westphalia, Germany, 40479
        • Recruiting
        • Marien Hospital Düsseldorf
        • Contact:
          • Jens-Peter Kruse
        • Contact:
          • David Tschirch
      • Düsseldorf, North Rhine-Westphalia, Germany, 40235
        • Recruiting
        • Luisenkrankenhaus GmbH Co KG
        • Contact:
          • Athina Kostara, Dr. med.
        • Contact:
          • Anne Huelsewiesche
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Recruiting
        • Evang. Kliniken Essen Mitte, Interdisziplinäres Brustkrebszentrum
        • Contact:
          • Sherko Kümmel, Prof.Dr
        • Contact:
          • Dorothea Schindowski
      • Goch, North Rhine-Westphalia, Germany, 47574
        • Recruiting
        • St. Antonius Hospital Kleve (Katholisches Kral Leistner Zentrum)
        • Contact:
          • Volker Runde, Prof. Dr.
        • Contact:
          • Elke Beeker-Cornelissen
      • Hagen, North Rhine-Westphalia, Germany, 58095
        • Recruiting
        • AGAPLESION Allgemeines Krankenhaus Hagen
        • Contact:
          • Nurhayat Yurtcu, Dr.
        • Contact:
          • Tamara Sitnikow
      • Hamm, North Rhine-Westphalia, Germany, 59073
        • Recruiting
        • St. Barbara Klinik
        • Contact:
          • Claudia Strunk, Dr.
        • Contact:
          • Gabriele Kerkmann
      • Herdecke, North Rhine-Westphalia, Germany, 58313
        • Recruiting
        • Gemeinschaftskrankenhaus Herdecke gemeinnützige GmbH
        • Contact:
          • Hanne- Kathrin Bracht
        • Contact:
          • Jasmin Schiprowski
      • Leverkusen, North Rhine-Westphalia, Germany, 51375
        • Recruiting
        • Klinikum Leverkusen, Am Gesundheitspark
        • Contact:
          • Andrea Heider, Dr.
        • Contact:
          • Katja Pöggel-Krämer
      • Lünen, North Rhine-Westphalia, Germany, 44534
        • Recruiting
        • Katholisches Klinikum Lünen/Werne
        • Contact:
          • Donat Romann, Dr.
        • Contact:
          • Ute Heine
      • Mönchengladbach, North Rhine-Westphalia, Germany, 41061
        • Recruiting
        • Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus
        • Contact:
          • Oleg Gluz, PD Dr.
        • Contact:
          • Carolin Sydlik
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitaetsklinikum Muenster
        • Contact:
          • Joke Tio, Dr.
        • Contact:
          • Stefanie Nienkemper
      • Münster, North Rhine-Westphalia, Germany, 48145
        • Recruiting
        • St. Franziskus-Hospital
        • Contact:
          • Sarah Damerau
        • Contact:
          • Christian Eichler, PD Dr.
      • Paderborn, North Rhine-Westphalia, Germany, 33098
        • Recruiting
        • Frauenklinik St. Louise - St. Vincenz-Krankenhaus GmbH
        • Contact:
          • Michael-Patrick Lux, Prof. Dr.
        • Contact:
          • Sara Heimann
      • Rheine, North Rhine-Westphalia, Germany, 48431
        • Recruiting
        • Mathias-Spital-Rheine
        • Contact:
          • Sebastian Bröckling, Dr. med.
        • Contact:
          • Denise Ernst
      • Troisdorf, North Rhine-Westphalia, Germany, 53840
        • Recruiting
        • Praxisnetzwerk Hämatologie/int. Onkologie
        • Contact:
          • Helmut Forstbauer, Dr. med.
        • Contact:
          • Stefanie Vorpahl
      • Unna, North Rhine-Westphalia, Germany, 59423
        • Recruiting
        • Christliches Klinikum Unna gGmbH
        • Contact:
          • Cristin Kühn, Dr. med.
        • Contact:
          • Vanessa Schuster
      • Wesel, North Rhine-Westphalia, Germany, 46485
        • Recruiting
        • Evangelisches Krankenhaus Wesel GmbH
        • Contact:
          • Daniela Rezek, Dr. med.
        • Contact:
          • Shqipe Lorito
      • Wuppertal, North Rhine-Westphalia, Germany, 42283
        • Recruiting
        • Helios Klinikum Wuppertal
        • Contact:
          • Vesna Bjelic-Radisic, Prof. Dr.
        • Contact:
          • Manuela Smiljanic
    • Rhineland-Palatinate
      • Worms, Rhineland-Palatinate, Germany, 67550
        • Recruiting
        • Klinikum Worms
        • Contact:
          • Antje Nixdorf, Dr. med.
        • Contact:
          • Tanja Knoll
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06110
        • Recruiting
        • Krankenhaus St. Elisabeth und St. Barbara Halle/Saale
        • Contact:
          • Tilmann Lantzsch, Dr. med.
        • Contact:
          • Mandy Babbe
      • Hansestadt Salzwedel, Saxony-Anhalt, Germany, 29410
        • Recruiting
        • Altmark- Klinikum
        • Contact:
          • Susanne Kraudelt, Dr.
        • Contact:
          • Steffi Mack-Eichner
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10367
        • Active, not recruiting
        • Medionko - Praxisklinik Krebsheilkunde Frauen
      • Berlin, State of Berlin, Germany, 10713
        • Recruiting
        • St. Gertrauden Krankenhaus Brustzentrum City Berlin
        • Contact:
          • Lidia Perlova-Griff
        • Contact:
          • Michaela Platzer
      • Berlin, State of Berlin, Germany, 12559
        • Recruiting
        • DRK Kliniken Berlin Köpenick
        • Contact:
          • Anke Kleine-Tebbe, Dr. med.
        • Contact:
          • Manuela Rösler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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:
  • 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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year distant recurrence-free interval (dRFI, according to STEEP criteria version 2.0)
Time Frame: 5 years
dRFIin all patients treated by (intensified) endocrine therapy alone (and with ovarian suppression in cases with enhanced clinical risk according to current AGO-recommendations)
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-year dRFI
Time Frame: 10 years
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)
10 years
5-year dRFI
Time Frame: 5 years
dRFI, according to STEEP criteria 2.0,in all patients treated by SOC chemotherapy treatment followed by ET+/-OFS
5 years
10-year dRFI
Time Frame: 10 years
dRFI, according to STEEP criteria 2.0,in all patients treated by SOC chemotherapy treatment followed by ET+/-OFS
10 years
5-year dDFS
Time Frame: 5 years
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)
5 years
10-year dDFS
Time Frame: 10 years
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
10 years
5-year OS
Time Frame: 5 years
overall survival (OS) in all patients and all treatment groups
5 years
10-year OS
Time Frame: 10 years
overall survival (OS) in all patients and all treatment groups
10 years
5-year breast cancer-free interval (BCFI, according to STEEP 2.0)
Time Frame: 5 years
BCFI in all patients and all treatment groups
5 years
10-year breast cancer-free interval (BCFI, according to STEEP 2.0)
Time Frame: 10 years
BCFI in all patients and all treatment groups
10 years
EORTC quality of life questionnaire BR23
Time Frame: every 3 months within 1st year
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.
every 3 months within 1st year
EORTC quality of life questionnaire C30
Time Frame: every 3 months within 1st year
compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.
every 3 months within 1st year
EORTC quality of life questionnaire BR23
Time Frame: every 6 months within 2nd year
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.
every 6 months within 2nd year
EORTC quality of life questionnaire C30
Time Frame: every 6 months within 2nd year
compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.
every 6 months within 2nd year
EORTC quality of life questionnaire BR23
Time Frame: yearly until 5 years
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.
yearly until 5 years
EORTC quality of life questionnaire C30
Time Frame: yearly until 5 years
compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.
yearly until 5 years
adherence to OFS and endocrine treatment
Time Frame: 10 years
Duration of intake of OFS and endocrine treatment in all patients
10 years
concordance between BluePrint®/MammaPrint® molecular subtyping results vs. pathological immune-histochemistry results
Time Frame: 10 years
concordance between BluePrint®/MammaPrint® molecular subtyping results and pathological immune-histochemistry results with respect to tumour type
10 years
endocrine response measured by post-endocrine Ki-67
Time Frame: 10 years
post-endocrine Ki-67 (≤10% and/or relative change vs. baseline) in patients treated by preoperative ET
10 years
5-year iDFS in node-negative patients with ultralow MammaPrint
Time Frame: 5 years
node-negative patients with ultralow MammaPrint® treated by shorter duration of ET (2-3 years at investigator decision)
5 years
10-year iDFS in node-negative patients with ultralow MammaPrint
Time Frame: 10 years
node-negative patients with ultralow MammaPrint® treated by shorter duration of ET (2-3 years at investigator decision)
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's Cancer Study Group GmbH

Collaborators

Agendia

Investigators

  • Principal Investigator: Oleg Gluz, PD Dr., Westdeutsche Studiengruppe GmbH
  • Study Director: Monika Graeser, PD Dr., Westdeutsche Studiengruppe GmbH
  • Principal Investigator: Nadia Harbeck, Prof. Dr., LMU Clinics, Breast Centre and CCC
  • Principal Investigator: Sherko Kuemmel, Prof. Dr., KEM, Clinics Essen-Mitte
  • Study Director: Ulrike Nitz, Prof. Dr., Westdeutsche Studiengruppe GmbH
  • Principal Investigator: Andreas Hartkopf, Prof. Dr., Univewrsity Hospital Tuebingen
  • Principal Investigator: Rachel Wuerstlein, Prof. Dr., Westdeutsche Studiengruppe GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Estimated)

March 1, 2035

Study Completion (Estimated)

June 1, 2035

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSG-NIS04 / PROOFS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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