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

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 hysterectomyor amenorrhea for <12 months; confirmation by blood hormone levels (FSH andestradiol in premenopausal range as per local normal range) recommended)

• Primary tumor diagnosis not older than three months prior to inclusion (primarydiagnosis defined as date of initial tumor biopsy)

• Estrogen- and/or progesterone-receptor-positive/HER2 negative early breast cancerwithout any clinical signs of metastases

• Adequate risk for recurrence:

• intermediate clinical risk for recurrence, defined as (clinical in case ofneoadjuvant 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 forrecurrence at investigator decision (e.g., very young age, low expression of hormonereceptors, existing co-morbidities, familial cancer burden, etc.) can be included onindividual decision basis or

• high clinical risk for recurrence, defined as either (clinical in case ofneoadjuvant treatment):

• c/pT2-4 or

• c/pN1 or

• Ki-67 ≥25% or

• G3

• Low genomic risk of recurrence by MammaPrint® (tested on treatment naïve tumorspecimen)

• 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 completedendocrine induction therapy), started, or planned adjuvant or neoadjuvant treatment)

• Availability of untreated tumor material (core biopsy if preoperative endocrinetherapy 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 genomiclow/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 tumormaterial

• Medical or psychological conditions that would not permit the patient to signinformed consent

• Legal incapacity or limited legal capacity

• Current participation in any interventional clinical trial which tests anticancerdrugs, immunotherapeutics, or antibody treatment for any type of neoplasm

• Non-compliance of the patient