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

NCT05792150

RecruitingN/A

Sponsor: Women's Cancer Study Group GmbH

Conditions: Female Breast Cancer

Countries: Germany

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 overview

Sex: FEMALE

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (71)
  • Baden-Baden, Baden-Wurttemberg, Germany
  • Pforzheim, Baden-Wurttemberg, Germany
  • Stuttgart, Baden-Wurttemberg, Germany
  • Ulm, Baden-Wurttemberg, Germany
  • Weinheim, Baden-Wurttemberg, Germany
  • Karlsruhe, Baden-Wüttemberg, Germany
  • Ravensburg, Baden-Wüttemberg, Germany
  • Amberg, Bavaria, Germany
  • Augsburg, Bavaria, Germany
  • Augsburg, Bavaria, Germany
  • Burghausen, Bavaria, Germany
  • Fürstenfeldbruck, Bavaria, Germany
  • München, Bavaria, Germany
  • München, Bavaria, Germany
  • Regensburg, Bavaria, Germany
  • Berlin, Brandenburg, Germany
  • Luckenwalde, Brandenburg, Germany
  • Erlangen, Erlangen, Germany
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Bremen, Free Hanseatic City of Bremen, Germany
  • Bremen, Free Hanseatic City of Bremen, Germany
  • Bremerhaven, Free Hanseatic City of Bremen, Germany
  • Bad Nauheim, Hesse, Germany
  • Bad Soden am Taunus, Hesse, Germany
  • Hanau, Hesse, Germany
  • Kassel, Hesse, Germany
  • Marburg, Hesse, Germany
  • Wiesbaden, Hesse, Germany
  • + 41 more on CT.gov