PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
Recruiting · NCT05792150 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →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.
Who can take part
Age range
18 Years to 60 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
- 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
Where it is running
60 locations listed.
- Marienhospital, Klinik für Gynäkologie und Geburtshilfe - Bottrop, 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
- 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
- Universitätsklinikum Erlangen - Erlangen, Erlangen, Germany
- Hämatologie/Onkologie Praxis - Bremen, Free Hanseatic City of Bremen, Germany
- DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH - Bremen, Free Hanseatic City of Bremen, Germany
- Klinikum Bremerhaven Reinkenheide - Bremerhaven, Free Hanseatic City of Bremen, Germany
- AGAPLESION Diakonie Hamburg - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Gynäkologische Praxisklinik Hamburg-Harburg - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Asklepios Klinik Barmbek - Hamburg, Free and Hanseatic City of Hamburg, 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
Showing 60 of 71 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →