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Clinical Trials in Germany / NCT05792150
Recruiting Observational

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

NCT05792150 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2022-12-07
Last updated
2026-08-05

Condition(s) studied

Female Breast Cancer

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (71)

FacilityCityRegionStatus
Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum Baden-Baden Baden-Wurttemberg Recruiting
Helios Klinikum Pforzheim, Brustzentrum Pforzheim Baden-Wurttemberg Recruiting
Diakonieklinikum Stuttgart, Brustzetrum Stuttgart Baden-Wurttemberg Active Not Recruiting
Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe Ulm Baden-Wurttemberg Recruiting
GRN Klinik Weinheim/ Gynäkologie/Brustzentrum Weinheim Baden-Wurttemberg Recruiting
ViDia Christliche Kliniken Karlsruhe Karlsruhe Baden-Wüttemberg Recruiting
Studienzentrum Onkologie Ravensburg Ravensburg Baden-Wüttemberg Recruiting
Klinikum St. Marien Amberg Amberg Bavaria Recruiting
HOP Gemeinschaftspraxis Dres. Heinrich/Bangerter, Augsburg Augsburg Bavaria Recruiting
Universitätsklinikum Augsburg, Brustzentrum Augsburg Bavaria Recruiting
Medias Klinikum Burghausen Bavaria Active Not Recruiting
Klinikum Fürstenfeldbruck, Westdeutsches Brust- Centrum Fürstenfeldbruck Bavaria Recruiting
Klinikum der Universität München München Bavaria Recruiting
Med. Zentrum f. Hämatologie und Onkologie München München Bavaria Active Not Recruiting
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde & Geburtshilfe Regensburg Bavaria Recruiting
Gemeinschaftskrankenhaus/ Brustzentrum Havelhöhe Berlin Brandenburg Recruiting
Klinikum Luckenwalde Luckenwalde Brandenburg Recruiting
Universitätsklinikum Erlangen Erlangen Erlangen Active Not Recruiting
AGAPLESION Diakonie Hamburg Hamburg Free and Hanseatic City of Hamburg Recruiting
Gynäkologische Praxisklinik Hamburg-Harburg Hamburg Free and Hanseatic City of Hamburg Recruiting
Asklepios Klinik Barmbek Hamburg Free and Hanseatic City of Hamburg Recruiting
Hämatologie/Onkologie Praxis Bremen Free Hanseatic City of Bremen Recruiting
DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH Bremen Free Hanseatic City of Bremen Recruiting
Klinikum Bremerhaven Reinkenheide Bremerhaven Free Hanseatic City of Bremen Recruiting
Gesundheitszentrum Wetterau gGmbH Hochwaldkrankenhaus Bad Nauheim Bad Nauheim Hesse Recruiting
Gynäkologische- Geburtshilfliche Klinik Bad Soden am Taunus Hesse Recruiting
Klinikum Hanau GmbH Hanau Hesse Active Not Recruiting
Elisabethkrankenhaus Kassel, Brustzentrum Kassel Hesse Recruiting
Universität Marburg, Klinik für Frauenheilkunde, Brustzentrum Marburg Hesse Active Not Recruiting
St. Josefs-Hospital Wiesbaden GmbH Wiesbaden Hesse Recruiting
DIAKOVERE Henriettenstift Hanover Lower Saxony Recruiting
Ärztehaus am Bahnhofsplatz Hildesheim Lower Saxony Recruiting
Studienzentrum Untere Ems Leer Lower Saxony Recruiting
Onkologische Praxis Oldenburg, Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie Oldenburg Lower Saxony Recruiting
Klinikum Südstadt Rostock Mecklenburg-Vorpommern Recruiting
Marienhospital Aachen Aachen North Rhine-Westphalia Recruiting
Gynäkologisches Zentrum Bonn North Rhine-Westphalia Active Not Recruiting
Universitätsklinikum Bonn Frauenheilkunde Bonn North Rhine-Westphalia Active Not Recruiting
Universitätsklinikum Bonn, Senologie Bonn North Rhine-Westphalia Recruiting
Kliniken der Stadt Köln Cologne North Rhine-Westphalia Recruiting

+ 31 more sites — see the full list on the official registry below.

More Women's Cancer Study Group GmbH trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05792150 on ClinicalTrials.gov ↗ ← All trials in Germany