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

Recruiting now

Conditions studied: Female Breast Cancer

In brief

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.

Key facts

Study ID

NCT05792150

Run by

Women's Cancer Study Group GmbH

People needed

1470

Starts

2022-12-07

Expected to finish

2035-06-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

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)
• 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).

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

Where it is running

• Elisabethkrankenhaus Kassel, Brustzentrum — Kassel, Hesse, Germany (enrolling)
• St. Josefs-Hospital Wiesbaden GmbH — Wiesbaden, Hesse, Germany (enrolling)
• Gynäkologische- Geburtshilfliche Klinik — Bad Soden am Taunus, Hesse, Germany (enrolling)
• Helios Klinikum Pforzheim, Brustzentrum — Pforzheim, Baden-Wurttemberg, Germany (enrolling)
• ViDia Christliche Kliniken Karlsruhe — Karlsruhe, Baden-Wüttemberg, Germany (enrolling)
• Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum — Baden-Baden, Baden-Wurttemberg, Germany (enrolling)
• Klinikum St. Marien Amberg — Amberg, Bavaria, Germany (enrolling)
• Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe — Ulm, Baden-Wurttemberg, Germany (enrolling)
• Universitätsklinikum Augsburg, Brustzentrum — Augsburg, Bavaria, Germany (enrolling)
• GRN Klinik Weinheim/ Gynäkologie/Brustzentrum — Weinheim, Baden-Wurttemberg, Germany (enrolling)
• Klinikum Fürstenfeldbruck, Westdeutsches Brust- Centrum — Fürstenfeldbruck, Bavaria, Germany (enrolling)
• Klinikum der Universität München — München, Bavaria, Germany (enrolling)
• Studienzentrum Onkologie Ravensburg — Ravensburg, Baden-Wüttemberg, Germany (enrolling)
• Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde & Geburtshilfe — Regensburg, Bavaria, Germany (enrolling)
• Gemeinschaftskrankenhaus/ Brustzentrum Havelhöhe — Berlin, Brandenburg, Germany (enrolling)
• Klinikum Luckenwalde — Luckenwalde, Brandenburg, Germany (enrolling)
• HOP Gemeinschaftspraxis Dres. Heinrich/Bangerter, Augsburg — Augsburg, Bavaria, Germany (enrolling)
• AGAPLESION Diakonie Hamburg — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)
• Gynäkologische Praxisklinik Hamburg-Harburg — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)
• Asklepios Klinik Barmbek — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)
• Hämatologie/Onkologie Praxis — Bremen, Free Hanseatic City of Bremen, Germany (enrolling)
• DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH — Bremen, Free Hanseatic City of Bremen, Germany (enrolling)
• Klinikum Bremerhaven Reinkenheide — Bremerhaven, Free Hanseatic City of Bremen, Germany (enrolling)
• Gesundheitszentrum Wetterau gGmbH Hochwaldkrankenhaus Bad Nauheim — Bad Nauheim, Hesse, Germany (enrolling)
• DIAKOVERE Henriettenstift — Hanover, Lower Saxony, Germany (enrolling)

Full record on ClinicalTrials.gov

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