Trial Title:
PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
NCT ID:
NCT05792150
Condition:
Female Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HR+
HER2-
EBC
early breast cancer
female
OFS
ET
chemotherapy
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
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 chemotherapy use in a real-world setting.
- to evaluate management of ovarian function in patients treated by adjuvant
chemotherapy according to investigator decision.
- to evaluate adherence to endocrine therapy (+/- ovarian function suppression).
- to evaluate the prognostic impact of clinicopathological markers (e.g., estrogen
receptor (ER), progesterone receptor (PR), HER2 receptor, Ki-67 at baseline and
after preoperative endocrine therapy (if any performed) by local pathology
assessment compared to genomic signature result.
- to assess the course of quality of life (QLQ BR23 and QLQ-C30) until 5 years of
treatment with OFS (Baseline, 3 months, 6 months, 12 months, 18 months, 2 years, 3
years, 4 years, 5 years)
In general, WSG aim to assess the quality of surveillance care in younger breast cancer
patients. WSG want to gain knowledge about endocrine induction treatment for indication
of chemotherapy followed by endocrine treatment or endocrine treatment alone. Also, WSG
aim at changes in duration of endocrine treatment (especially in high-risk patients up to
10 years) and introduction of intensified endocrine therapy (OFS) in combination with
GnRH-analogues since publication of the SOFT and TEXT trials.
Criteria for eligibility:
Study pop:
For this registry, it is planned to screen N=3000 pre- and perimenopausal patients with
early breast cancer who meet the inclusion criteria, i.e., intermediate to high clinical
risk for recurrence, and who will receive or have received a routine genomic testing by
MammaPrint® with a low/ultralow genomic risk.
It is anticipated that 75% of these patients will be nodal negative and 25% nodal
positive.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
ViDia Christliche Kliniken Karlsruhe
Address:
City:
Karlsruhe
Zip:
76135
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Oliver Tomé, Dr.
Facility:
Name:
Studienzentrum Onkologie Ravensburg
Address:
City:
Ravensburg
Zip:
88212
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Thomas Decker, Prof. Dr.med
Contact backup:
Last name:
Irina Gossen
Facility:
Name:
Klinikum St. Marien Amberg
Address:
City:
Amberg
Zip:
9224
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Tanja Hauzenberger, Dr. med
Contact backup:
Last name:
Jacqueline Roy
Facility:
Name:
Klinikum der Universität München
Address:
City:
München
Zip:
80336
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Nadia Harbeck, Prof. Dr.
Contact backup:
Last name:
Beate Rank
Facility:
Name:
Med. Zentrum f. Hämatologie und Onkologie München
Address:
City:
München
Zip:
80639
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Oliver Stötzer, PD Dr.
Contact backup:
Last name:
Heike Fengler
Facility:
Name:
Klinikum Hanau GmbH
Address:
City:
Hanau
Zip:
63450
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Thomas Müller, Prof. Dr.
Contact backup:
Last name:
Violeta Fricker
Facility:
Name:
St. Josefs-Hospital Wiesbaden GmbH
Address:
City:
Wiesbaden
Zip:
65189
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Antje Lehnert, Dr. med.
Contact backup:
Last name:
Andrea Lunkenheimer
Facility:
Name:
Klinikum Südstadt
Address:
City:
Rostock
Zip:
18059
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Juliane Terpe-Weiland, Dr. med.
Contact backup:
Last name:
Michaela Stecher
Facility:
Name:
Marienhospital Aachen
Address:
City:
Aachen
Zip:
52066
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Mahmoud Danaei, Dr.
Contact backup:
Last name:
Birgit Dreyer
Facility:
Name:
Gynäkologisches Zentrum
Address:
City:
Bonn
Zip:
53111
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christian Kurbacher, PD Dr. med
Contact backup:
Last name:
Andrea Kremer- Heß
Facility:
Name:
Universitätsklinikum Bonn Frauenheilkunde
Address:
City:
Bonn
Zip:
53127
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Anne Bachmann
Contact backup:
Last name:
Sigrid Clade
Facility:
Name:
St. Vincenz-Krankenhaus Datteln
Address:
City:
Datteln
Zip:
45711
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Ayoub Abdu, Dr. med.
Contact backup:
Last name:
Silvia Schneider
Facility:
Name:
Luisenkrankenhaus GmbH Co KG
Address:
City:
Düsseldorf
Zip:
40235
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Athina Kostara, Dr. med.
Contact backup:
Last name:
Anne Huelsewiesche
Facility:
Name:
Marien Hospital Düsseldorf
Address:
City:
Düsseldorf
Zip:
40479
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jens-Peter Kruse
Contact backup:
Last name:
David Tschirch
Facility:
Name:
Kliniken der Stadt Köln
Address:
City:
Köln
Zip:
51067
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Lotta Fischer, Dr.
Contact backup:
Last name:
Claudia Weise
Facility:
Name:
Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus
Address:
City:
Moenchengladbach
Zip:
41061
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Oleg Gluz, PD. Dr. med.
Email:
oleg.gluz@wsg-online.com
Contact backup:
Last name:
Iris Scheffen, Dr. med.
Email:
iris.scheffen@wsg-online.com
Investigator:
Last name:
Oleg Gluz, PD Dr.
Email:
Principal Investigator
Facility:
Name:
Mathias-Spital-Rheine
Address:
City:
Rheine
Zip:
48431
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Sebastian Bröckling, Dr. med.
Contact backup:
Last name:
Denise Ernst
Facility:
Name:
Praxisnetzwerk Hämatologie/int. Onkologie
Address:
City:
Troisdorf
Zip:
53840
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Helmut Forstbauer, Dr. med.
Contact backup:
Last name:
Sarah Wackerow
Facility:
Name:
Christliches Klinikum Unna gGmbH
Address:
City:
Unna
Zip:
59423
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Cristin Kühn, Dr. med.
Contact backup:
Last name:
Vanessa Schuster
Facility:
Name:
Evangelisches Krankenhaus Wesel GmbH
Address:
City:
Wesel
Zip:
46485
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Daniela Rezek, Dr. med.
Contact backup:
Last name:
Aniela Klonowski
Facility:
Name:
Helios Klinikum Wuppertal
Address:
City:
Wuppertal
Zip:
42283
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Vesna Bjelic-Radisic, Prof. Dr.
Contact backup:
Last name:
Manuela Smiljanic
Facility:
Name:
Klinikum Worms
Address:
City:
Worms
Zip:
67550
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Antje Nixdorf, Dr. med.
Contact backup:
Last name:
Tanja Knoll
Facility:
Name:
Medionko - Praxisklinik Krebsheilkunde Frauen
Address:
City:
Berlin
Zip:
10367
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Gülten Oskay-Özcelik, PD Dr. med.
Contact backup:
Last name:
Alena Keil
Facility:
Name:
DRK Kliniken Berlin Köpenick
Address:
City:
Berlin
Zip:
12559
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Anke Kleine-Tebbe, Dr. med.
Contact backup:
Last name:
Manuela Rösler
Facility:
Name:
Marienhospital, Klinik für Gynäkologie und Geburtshilfe
Address:
City:
Bottrop
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Hans-Christian Kolberg, PD Dr.
Contact backup:
Last name:
Katharina Freienstein
Facility:
Name:
DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
Address:
City:
Bremen
Zip:
28239
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Karen Wimmer-Freys, Dr.
Contact backup:
Last name:
Stina Eckardt
Facility:
Name:
AGAPLESION Diakonie Hamburg
Address:
City:
Hamburg
Zip:
20259
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Mustafa Celalettin Ugur, Dr.
Contact backup:
Last name:
Mirjam Ahrens
Facility:
Name:
Gynäkologische Praxisklinik Hamburg-Harburg
Address:
City:
Hamburg
Zip:
21073
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christoph Großmann, Dr. med.
Contact backup:
Last name:
Belma Salihadgic
Facility:
Name:
Asklepios Klinik Barmbek
Address:
City:
Hamburg
Zip:
22307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Katharina Maria Seiffert, Dr.med.
Contact backup:
Last name:
Sabine Drießelmann
Facility:
Name:
Helios Klinikum Krefeld, Zentrum für Ambulante Gynäkologische Onkologie - Studienabteilung
Address:
City:
Krefeld
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Gunther Rogmans, Dr.
Contact backup:
Last name:
Gerswin Garcia
Facility:
Name:
MKS St. Paulus Schwerte (ehemals Marienkrankenhaus)
Address:
City:
Schwerte
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Sarah Wetzig
Contact backup:
Last name:
Kristin Backhaus
Facility:
Name:
Klinikum Traunstein, Frauenklinik Südostbayern
Address:
City:
Traunstein
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christian Schindlbeck, Prof. Dr.
Contact backup:
Last name:
Ursula Ghasemi
Start date:
December 7, 2022
Completion date:
June 2035
Lead sponsor:
Agency:
West German Study Group
Agency class:
Other
Collaborator:
Agency:
Agendia
Agency class:
Industry
Source:
West German Study Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05792150
