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

NCT05792150 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1470

Last updated 2026-01-26

No results posted yet for this 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.

Conditions

  • Female Breast Cancer

Sponsors & Collaborators

  • Agendia

    collaborator INDUSTRY

  • West German Study Group

    lead OTHER

Principal Investigators

  • Oleg Gluz, PD Dr. · Westdeutsche Studiengruppe GmbH

  • Rachel Wuerstlein, Prof. Dr. · Westdeutsche Studiengruppe GmbH

  • Monika Graeser, PD Dr. · Westdeutsche Studiengruppe GmbH

  • Nadia Harbeck, Prof. Dr. · LMU Clinics, Breast Centre and CCC

  • Sherko Kuemmel, Prof. Dr. · KEM, Clinics Essen-Mitte

  • Ulrike Nitz, Prof. Dr. · Westdeutsche Studiengruppe GmbH

  • Andreas Hartkopf, Prof. Dr. · Univewrsity Hospital Tuebingen

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2035-03-31
Completion
2035-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05792150 on ClinicalTrials.gov