NCT05792150 PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 1,470 participants in total. It began in 2022-12-07 with a primary completion date of 2035-03.

Brief 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.

Eligibility 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

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