Overview

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

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