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RECRUITING

NCT05792150

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

Sponsor: West German Study Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

1470

Start Date

2022-12-07

Completion Date

2035-06

Last Updated

2026-01-26

Healthy Volunteers

Conditions

Female Breast Cancer

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

Locations (71)

Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum

Baden-Baden, Baden-Wurttemberg, Germany

Helios Klinikum Pforzheim, Brustzentrum

Pforzheim, Baden-Wurttemberg, Germany

Diakonieklinikum Stuttgart, Brustzetrum

Stuttgart, Baden-Wurttemberg, Germany

Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe

Ulm, Baden-Wurttemberg, Germany

GRN Klinik Weinheim/ Gynäkologie/Brustzentrum

Weinheim, Baden-Wurttemberg, Germany

ViDia Christliche Kliniken Karlsruhe

Karlsruhe, Baden-Wüttemberg, Germany

Studienzentrum Onkologie Ravensburg

Ravensburg, Baden-Wüttemberg, Germany

Klinikum St. Marien Amberg

Amberg, Bavaria, Germany

HOP Gemeinschaftspraxis Dres. Heinrich/Bangerter, Augsburg

Augsburg, Bavaria, Germany

Universitätsklinikum Augsburg, Brustzentrum

Augsburg, Bavaria, Germany

Medias Klinikum

Burghausen, Bavaria, Germany

Klinikum Fürstenfeldbruck, Westdeutsches Brust- Centrum

Fürstenfeldbruck, Bavaria, Germany

Klinikum der Universität München

München, Bavaria, Germany

Med. Zentrum f. Hämatologie und Onkologie München

München, Bavaria, Germany

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

Regensburg, Bavaria, Germany

Gemeinschaftskrankenhaus/ Brustzentrum Havelhöhe

Berlin, Brandenburg, Germany

Klinikum Luckenwalde

Luckenwalde, Brandenburg, Germany

Klinikum Bremerhaven Reinkenheide

Bremerhaven, City state Bremen, Germany

Gesundheitszentrum Wetterau gGmbH Hochwaldkrankenhaus Bad Nauheim

Bad Nauheim, Hesse, Germany

Gynäkologische- Geburtshilfliche Klinik

Bad Soden am Taunus, Hesse, Germany

Klinikum Hanau GmbH

Hanau, Hesse, Germany

Elisabethkrankenhaus Kassel, Brustzentrum

Kassel, Hesse, Germany

Universität Marburg, Klinik für Frauenheilkunde, Brustzentrum

Marburg, Hesse, Germany

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, Hesse, Germany

DIAKOVERE Henriettenstift

Hanover, Lower Saxony, Germany

Ärztehaus am Bahnhofsplatz

Hildesheim, Lower Saxony, Germany

Studienzentrum Untere Ems

Leer, Lower Saxony, Germany

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

Oldenburg, Lower Saxony, Germany

Klinikum Südstadt

Rostock, Mecklenburg-Vorpommern, Germany

Marienhospital Aachen

Aachen, North Rhine-Westphalia, Germany

Gynäkologisches Zentrum

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Bonn Frauenheilkunde

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Bonn, Senologie

Bonn, North Rhine-Westphalia, Germany

Kliniken der Stadt Köln

Cologne, North Rhine-Westphalia, Germany

St. Vincenz-Krankenhaus Datteln

Datteln, North Rhine-Westphalia, Germany

Klinikum Dortmund gGmbH, Beurhausstr.40

Dortmund, North Rhine-Westphalia, Germany

Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Brustzentrum

Duisburg, North Rhine-Westphalia, Germany

Luisenkrankenhaus GmbH Co KG

Düsseldorf, North Rhine-Westphalia, Germany

Marien Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Evang. Kliniken Essen Mitte, Interdisziplinäres Brustkrebszentrum

Essen, North Rhine-Westphalia, Germany

St. Antonius Hospital Kleve (Katholisches Kral Leistner Zentrum)

Goch, North Rhine-Westphalia, Germany

AGAPLESION Allgemeines Krankenhaus Hagen

Hagen, North Rhine-Westphalia, Germany

St. Barbara Klinik

Hamm, North Rhine-Westphalia, Germany

Gemeinschaftskrankenhaus Herdecke gemeinnützige GmbH

Herdecke, North Rhine-Westphalia, Germany

Klinikum Leverkusen, Am Gesundheitspark

Leverkusen, North Rhine-Westphalia, Germany

Katholisches Klinikum Lünen/Werne

Lünen, North Rhine-Westphalia, Germany

Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus

Mönchengladbach, North Rhine-Westphalia, Germany

St. Franziskus-Hospital

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia, Germany

Frauenklinik St. Louise - St. Vincenz-Krankenhaus GmbH

Paderborn, North Rhine-Westphalia, Germany

Mathias-Spital-Rheine

Rheine, North Rhine-Westphalia, Germany

Praxisnetzwerk Hämatologie/int. Onkologie

Troisdorf, North Rhine-Westphalia, Germany

Christliches Klinikum Unna gGmbH

Unna, North Rhine-Westphalia, Germany

Evangelisches Krankenhaus Wesel GmbH

Wesel, North Rhine-Westphalia, Germany

Helios Klinikum Wuppertal

Wuppertal, North Rhine-Westphalia, Germany

Klinikum Worms

Worms, Rhineland-Palatinate, Germany

Krankenhaus St. Elisabeth und St. Barbara Halle/Saale

Halle, Saxony-Anhalt, Germany

Altmark- Klinikum

Salzwedel, Saxony-Anhalt, Germany

Medionko - Praxisklinik Krebsheilkunde Frauen

Berlin, Germany

St. Gertrauden Krankenhaus Brustzentrum City Berlin

Berlin, Germany

DRK Kliniken Berlin Köpenick

Berlin, Germany

Marienhospital, Klinik für Gynäkologie und Geburtshilfe

Bottrop, Germany

Hämatologie/Onkologie Praxis

Bremen, Germany

DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

Bremen, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

AGAPLESION Diakonie Hamburg

Hamburg, Germany

Gynäkologische Praxisklinik Hamburg-Harburg

Hamburg, Germany

Asklepios Klinik Barmbek

Hamburg, Germany

Helios Klinikum Krefeld, Zentrum für Ambulante Gynäkologische Onkologie - Studienabteilung

Krefeld, Germany

MKS St. Paulus Schwerte (ehemals Marienkrankenhaus)

Schwerte, Germany

Klinikum Traunstein, Frauenklinik Südostbayern

Traunstein, Germany

Clinical Research Directory

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

Summary

Key Details

Conditions

Eligibility Criteria

Locations (71)