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

NCT05792150 | Recruiting

• 1 other identifier: WSG-NIS04 / PROOFS
• Study Type: observational
• Target: 1,470
• Locations: 1 country
• Sites: 71

Brief 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. 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

Female Breast Cancer

Keywords

HR+; HER2-; EBC; early breast cancer; female; OFS; ET; chemotherapy

Outcome Measures

Primary Outcomes (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)

  5 years

Secondary Outcomes (20)

• 10-year dRFI

  10 years

• 5-year dRFI

  5 years

• 10-year dRFI

  10 years

• 5-year dDFS

  5 years

• 10-year dDFS

  10 years

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West German Study Group: lead
• Agendia: collaborator

Study Sites (71)

Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum

Baden-Baden, Baden-Wurttemberg, 76532, Germany

RECRUITING

Helios Klinikum Pforzheim, Brustzentrum

Pforzheim, Baden-Wurttemberg, 75175, Germany

RECRUITING

Diakonieklinikum Stuttgart, Brustzetrum

Stuttgart, Baden-Wurttemberg, 70176, Germany

ACTIVE NOT RECRUITING

Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe

Ulm, Baden-Wurttemberg, 89075, Germany

RECRUITING

GRN Klinik Weinheim/ Gynäkologie/Brustzentrum

Weinheim, Baden-Wurttemberg, 69469, Germany

RECRUITING

ViDia Christliche Kliniken Karlsruhe

Karlsruhe, Baden-Wüttemberg, 76135, Germany

RECRUITING

Studienzentrum Onkologie Ravensburg

Ravensburg, Baden-Wüttemberg, 88212, Germany

RECRUITING

Klinikum St. Marien Amberg

Amberg, Bavaria, 9224, Germany

RECRUITING

HOP Gemeinschaftspraxis Dres. Heinrich/Bangerter, Augsburg

Augsburg, Bavaria, 86150, Germany

RECRUITING

Universitätsklinikum Augsburg, Brustzentrum

Augsburg, Bavaria, 86156, Germany

RECRUITING

Medias Klinikum

Burghausen, Bavaria, 84489, Germany

ACTIVE NOT RECRUITING

Klinikum Fürstenfeldbruck, Westdeutsches Brust- Centrum

Fürstenfeldbruck, Bavaria, 82256, Germany

RECRUITING

Klinikum der Universität München

München, Bavaria, 80336, Germany

RECRUITING

Med. Zentrum f. Hämatologie und Onkologie München

München, Bavaria, 80639, Germany

ACTIVE NOT RECRUITING

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

Regensburg, Bavaria, 93053, Germany

RECRUITING

Gemeinschaftskrankenhaus/ Brustzentrum Havelhöhe

Berlin, Brandenburg, 14089, Germany

RECRUITING

Klinikum Luckenwalde

Luckenwalde, Brandenburg, 14943, Germany

RECRUITING

Klinikum Bremerhaven Reinkenheide

Bremerhaven, City state Bremen, 27574, Germany

RECRUITING

Gesundheitszentrum Wetterau gGmbH Hochwaldkrankenhaus Bad Nauheim

Bad Nauheim, Hesse, 61231, Germany

RECRUITING

Gynäkologische- Geburtshilfliche Klinik

Bad Soden am Taunus, Hesse, 65812, Germany

RECRUITING

Klinikum Hanau GmbH

Hanau, Hesse, 63450, Germany

ACTIVE NOT RECRUITING

Elisabethkrankenhaus Kassel, Brustzentrum

Kassel, Hesse, 34117, Germany

RECRUITING

Universität Marburg, Klinik für Frauenheilkunde, Brustzentrum

Marburg, Hesse, 35043, Germany

ACTIVE NOT RECRUITING

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, Hesse, 65189, Germany

RECRUITING

DIAKOVERE Henriettenstift

Hanover, Lower Saxony, 30171, Germany

RECRUITING

Ärztehaus am Bahnhofsplatz

Hildesheim, Lower Saxony, 31134, Germany

RECRUITING

Studienzentrum Untere Ems

Leer, Lower Saxony, 26789, Germany

RECRUITING

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

Oldenburg, Lower Saxony, 26121, Germany

RECRUITING

Klinikum Südstadt

Rostock, Mecklenburg-Vorpommern, 18059, Germany

RECRUITING

Marienhospital Aachen

Aachen, North Rhine-Westphalia, 52066, Germany

RECRUITING

Gynäkologisches Zentrum

Bonn, North Rhine-Westphalia, 53111, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Bonn Frauenheilkunde

Bonn, North Rhine-Westphalia, 53127, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Bonn, Senologie

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Kliniken der Stadt Köln

Cologne, North Rhine-Westphalia, 51067, Germany

RECRUITING

St. Vincenz-Krankenhaus Datteln

Datteln, North Rhine-Westphalia, 45711, Germany

RECRUITING

Klinikum Dortmund gGmbH, Beurhausstr.40

Dortmund, North Rhine-Westphalia, 44137, Germany

RECRUITING

Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Brustzentrum

Duisburg, North Rhine-Westphalia, 47053, Germany

RECRUITING

Luisenkrankenhaus GmbH Co KG

Düsseldorf, North Rhine-Westphalia, 40235, Germany

RECRUITING

Marien Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40479, Germany

RECRUITING

Evang. Kliniken Essen Mitte, Interdisziplinäres Brustkrebszentrum

Essen, North Rhine-Westphalia, 45136, Germany

RECRUITING

St. Antonius Hospital Kleve (Katholisches Kral Leistner Zentrum)

Goch, North Rhine-Westphalia, 47574, Germany

ACTIVE NOT RECRUITING

AGAPLESION Allgemeines Krankenhaus Hagen

Hagen, North Rhine-Westphalia, 58095, Germany

RECRUITING

St. Barbara Klinik

Hamm, North Rhine-Westphalia, 59073, Germany

RECRUITING

Gemeinschaftskrankenhaus Herdecke gemeinnützige GmbH

Herdecke, North Rhine-Westphalia, 58313, Germany

RECRUITING

Klinikum Leverkusen, Am Gesundheitspark

Leverkusen, North Rhine-Westphalia, 51375, Germany

ACTIVE NOT RECRUITING

Katholisches Klinikum Lünen/Werne

Lünen, North Rhine-Westphalia, 44534, Germany

RECRUITING

Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

RECRUITING

St. Franziskus-Hospital

Münster, North Rhine-Westphalia, 48145, Germany

RECRUITING

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Frauenklinik St. Louise - St. Vincenz-Krankenhaus GmbH

Paderborn, North Rhine-Westphalia, 33098, Germany

RECRUITING

Mathias-Spital-Rheine

Rheine, North Rhine-Westphalia, 48431, Germany

RECRUITING

Praxisnetzwerk Hämatologie/int. Onkologie

Troisdorf, North Rhine-Westphalia, 53840, Germany

RECRUITING

Christliches Klinikum Unna gGmbH

Unna, North Rhine-Westphalia, 59423, Germany

RECRUITING

Evangelisches Krankenhaus Wesel GmbH

Wesel, North Rhine-Westphalia, 46485, Germany

RECRUITING

Helios Klinikum Wuppertal

Wuppertal, North Rhine-Westphalia, 42283, Germany

RECRUITING

Klinikum Worms

Worms, Rhineland-Palatinate, 67550, Germany

RECRUITING

Krankenhaus St. Elisabeth und St. Barbara Halle/Saale

Halle, Saxony-Anhalt, 06110, Germany

RECRUITING

Altmark- Klinikum

Salzwedel, Saxony-Anhalt, 29410, Germany

RECRUITING

Medionko - Praxisklinik Krebsheilkunde Frauen

Berlin, 10367, Germany

ACTIVE NOT RECRUITING

St. Gertrauden Krankenhaus Brustzentrum City Berlin

Berlin, 10713, Germany

RECRUITING

DRK Kliniken Berlin Köpenick

Berlin, 12559, Germany

RECRUITING

Marienhospital, Klinik für Gynäkologie und Geburtshilfe

Bottrop, Germany

RECRUITING

Hämatologie/Onkologie Praxis

Bremen, 28209, Germany

RECRUITING

DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

Bremen, 28239, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

ACTIVE NOT RECRUITING

AGAPLESION Diakonie Hamburg

Hamburg, 20259, Germany

RECRUITING

Gynäkologische Praxisklinik Hamburg-Harburg

Hamburg, 21073, Germany

RECRUITING

Asklepios Klinik Barmbek

Hamburg, 22307, Germany

RECRUITING

Helios Klinikum Krefeld, Zentrum für Ambulante Gynäkologische Onkologie - Studienabteilung

Krefeld, Germany

RECRUITING

MKS St. Paulus Schwerte (ehemals Marienkrankenhaus)

Schwerte, Germany

ACTIVE NOT RECRUITING

Klinikum Traunstein, Frauenklinik Südostbayern

Traunstein, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Oleg Gluz, PD Dr.

  Westdeutsche Studiengruppe GmbH

  PRINCIPAL INVESTIGATOR

• Rachel Wuerstlein, Prof. Dr.

  Westdeutsche Studiengruppe GmbH

  PRINCIPAL INVESTIGATOR

• Monika Graeser, PD Dr.

  Westdeutsche Studiengruppe GmbH

  STUDY DIRECTOR

• Nadia Harbeck, Prof. Dr.

  LMU Clinics, Breast Centre and CCC

  PRINCIPAL INVESTIGATOR

• Sherko Kuemmel, Prof. Dr.

  KEM, Clinics Essen-Mitte

  PRINCIPAL INVESTIGATOR

• Ulrike Nitz, Prof. Dr.

  Westdeutsche Studiengruppe GmbH

  STUDY DIRECTOR

• Andreas Hartkopf, Prof. Dr.

  Univewrsity Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Moellers

CONTACT

00492161566 23-0; julian.moellers@wsg-online.com

Anja Braschoss, MD

CONTACT

04917682119153; anja.braschoss@wsg-online.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 31, 2023
• Study Start: December 7, 2022
• Primary Completion (Estimated): March 1, 2035
• Study Completion (Estimated): June 1, 2035
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (71)