Registry for Premenopausal Women with Breast Cancer Treated with Ovarian Function Suppression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry aims to gather real-world data on the use of ovarian function suppression (OFS) in pre- and perimenopausal women diagnosed with early breast cancer. It will evaluate the impact of OFS on treatment outcomes, adherence to endocrine therapy, and quality of life over a period of up to 10 years. The study will also assess the prognostic significance of various clinicopathological markers and genomic signatures in determining treatment strategies. By following patients' treatments and outcomes, the registry seeks to enhance understanding of optimal management in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum
  Baden-Baden, Baden-Wurttemberg, Germany Recruiting
• Helios Klinikum Pforzheim, Brustzentrum
  Pforzheim, Baden-Wurttemberg, Germany Recruiting
• Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe
  Ulm, Baden-Wurttemberg, Germany Recruiting
• GRN Klinik Weinheim/ Gynäkologie/Brustzentrum
  Weinheim, Baden-Wurttemberg, Germany Recruiting
• ViDia Christliche Kliniken Karlsruhe
  Karlsruhe, Baden-Wüttemberg, Germany Recruiting
• Studienzentrum Onkologie Ravensburg
  Ravensburg, Baden-Wüttemberg, Germany Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Oleg Gluz, PD Dr. — Westdeutsche Studiengruppe GmbH
• Study coordinator: Julian Moellers
• Email: julian.moellers@wsg-online.com
• Phone: 00492161566 23-0

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.