Status:
RECRUITING
PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
Lead Sponsor:
West German Study Group
Collaborating Sponsors:
Agendia
Conditions:
Female Breast Cancer
Eligibility:
FEMALE
18-60 years
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 d...
Detailed Description
This registry aims * to confirm an excellent outcome in pre-/perimenopausal patients treated by endocrine therapy (+ ovarian suppression) in patients with low genomic risk by MammaPrint® without chem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2035
Estimated Enrollment :
1470 Patients enrolled
Trial Details
Trial ID
NCT05792150
Start Date
December 7 2022
End Date
June 1 2035
Last Update
January 26 2026
Active Locations (71)
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1
Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum
Baden-Baden, Baden-Wurttemberg, Germany, 76532
2
Helios Klinikum Pforzheim, Brustzentrum
Pforzheim, Baden-Wurttemberg, Germany, 75175
3
Diakonieklinikum Stuttgart, Brustzetrum
Stuttgart, Baden-Wurttemberg, Germany, 70176
4
Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe
Ulm, Baden-Wurttemberg, Germany, 89075