Letzte Aktualisierung: 06.05.2026
Brustkrebs (Mammakarzinom) [C50]
PROOFS
Studieninformationen
PROOFS-Registry: Real world data and long-term follow-up of female pre- and perimenopausal patients with luminal early breast cancer with intermediate to high clinical risk for recurrence and low genomic recurrence-risk measured by MammaPrint®, treated by standard-of-care endocrine treatment plus ovarian function suppression (OFS) or standard-of-care chemotherapy treatment followed by endocrine treatment
Ziele
Primäres Prüfziel
The primary objective is to assess the 5-year distant recurrence-free interval (dRFI, according to STEEP criteria version 2.0) [9] in all patients treated by (intensified) endocrine therapy alone (and with ovarian suppression in cases with enhanced clinical risk according to current AGO-recommendations)
Sekundäre Prüfziele für die Behandlungsarme:
to assess 10-year dRFI, according to STEEP 2.0 criteria, in all patients treated by (intensified) endocrine therapy alone (and with ovarian suppression in cases with enhanced clinical risk according to current AGO-recommendations) to assess 5- and 10-year dRFI, according to STEEP 2.0 criteria, in all patients treated by SOC chemotherapy treatment followed by ET+/-OFS to assess 5- and 10-year 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) to assess 5- and 10-year overall survival (OS) in all patients and all treatment groups to assess 5- and 10-year breast cancer-free interval (BCFI, according to STEEP 2.0) in all patients and all treatment groups to describe and compare the quality of life (QLQ BR23 and QLQ-C30) at baseline, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years 4 years and after 5 years between all treatment groups to capture adherence to OFS and endocrine treatment in all patients to assess concordance between BluePrint®/MammaPrint® molecular subtyping results vs. pathological immune-histochemistry results to assess endocrine response measured by post-endocrine Ki-67 (≤10% and/or relative change vs. baseline) in patients treated by preoperative ET according to MammaPrint® result to perform sub analyses of all endpoints using the MINDACT clinical high-risk clientele definition (i.e., G1, N0, tumor size >3cm and N+, tumor size >2-5cm; G2, N0, tumor size >2cm and N+, any tumor size; G3, N0, tumor size >1cm and N+, any tumor size) to assess the prognostic value of ultralow versus low MammaPrint® assessment for dRFI and OS to assess the additional prognostic value of ultralow / low MammaPrint® assessment adjusted for clinicopathological markers (histology, grade, expression levels of ER, PR, HER2 and Ki-67 at baseline and after preoperative endocrine therapy) for dRFI and OS 5 and 10-year iDFS in node-negative patients with ultralow MammaPrint® treated by shorter duration of ET (2-3 years at investigator decision) Endpoints Primary endpoint: 5-year distant recurrence-free interval (dRFI, according to STEEP criteria version 2.0) [9] in all patients treated by (intensified) endocrine therapy alone (and with ovarian suppression in cases with enhanced clinical risk according to current AGO-recommendations).
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
Prä- und perimenopausale Patientinnen mit luminalem Brustkrebs/Mammakarzinom im Frühstadium mit mittlerem bis hohem klinischen Rezidivrisiko und geringem genomischen Rezidivrisiko
Mutation
Patienten
Alter
Einschlusskriterien
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 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).
Ausschlusskriterien
Any other genomic testing, besides MammaPrint®/BluePrint®, 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 with medicinal products Non-compliance of the patient
Therapie
Intervention
Substanz
| Prüfplancode | PROOFS-Registry |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | - |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
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Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)




