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

Real World Data and Long-term FU of Pre-/Perimenopausal Women With Luminal EBC With Intermediate to High Clinical and Low Genomic Recurrence-risk Measured by MammaPrint®, Treated by SOC ET+OFS or SOC Chemotherapy Treatment Followed by ET

Observational West German Study Group · NCT05792150

This study is collecting information from premenopausal women with early breast cancer to see how ovarian function suppression affects their treatment results, medication adherence, and quality of life over time.

Quick facts

Study typeObservational
Enrollment1470 (estimated)
Ages18 Years to 60 Years
SexFemale
SponsorWest German Study Group Academic / other
Drugs / interventionschemotherapy
Locations71 sites (Baden-Baden, Baden-Wurttemberg and 70 other locations)
Trial IDNCT05792150 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are pre- or perimenopausal women under 60 years old with early-stage, hormone receptor-positive, HER2-negative breast cancer.

Not a fit: Patients with metastatic breast cancer or those who do not meet the hormonal and clinical criteria for inclusion may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could lead to improved treatment strategies and outcomes for premenopausal women with breast cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches to ovarian function suppression in breast cancer treatment, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Baden-Baden, Baden-Wurttemberg and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Female Breast CancerHR+HER2-EBCearly breast cancerfemaleOFSET
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.