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Study identifier: NCT05792150 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Female Breast Cancer  ·  Sponsor: West German Study Group

PhaseN/A
Planned participants1470
Who can joinFemale, 18 Years to 60 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Julian Moellers  ·  00492161566 23-0  ·  julian.moellers@wsg-online.com

Anja Braschoss, MD  ·  04917682119153  ·  anja.braschoss@wsg-online.com

Always discuss trial participation with your own doctor first.

Locations (71)

Klinikum-Mittelbaden GmbH, Studienzentrale/BrustzentrumBaden-Baden, Baden-Wurttemberg, GermanyRecruiting
Helios Klinikum Pforzheim, BrustzentrumPforzheim, Baden-Wurttemberg, GermanyRecruiting
Diakonieklinikum Stuttgart, BrustzetrumStuttgart, Baden-Wurttemberg, GermanyActive Not Recruiting
Universitätsfrauenklinik Ulm - Frauenheilkunde und GeburtshilfeUlm, Baden-Wurttemberg, GermanyRecruiting
GRN Klinik Weinheim/ Gynäkologie/BrustzentrumWeinheim, Baden-Wurttemberg, GermanyRecruiting
ViDia Christliche Kliniken KarlsruheKarlsruhe, Baden-Wüttemberg, GermanyRecruiting
Studienzentrum Onkologie RavensburgRavensburg, Baden-Wüttemberg, GermanyRecruiting
Klinikum St. Marien AmbergAmberg, Bavaria, GermanyRecruiting
HOP Gemeinschaftspraxis Dres. Heinrich/Bangerter, AugsburgAugsburg, Bavaria, GermanyRecruiting
Universitätsklinikum Augsburg, BrustzentrumAugsburg, Bavaria, GermanyRecruiting
Medias KlinikumBurghausen, Bavaria, GermanyActive Not Recruiting
Klinikum Fürstenfeldbruck, Westdeutsches Brust- CentrumFürstenfeldbruck, Bavaria, GermanyRecruiting

+ 59 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05792150