Clinical trial NCT03503799: Reaching for Evidence-baSed Chemotherapy Use in Endocrine Sensitive Breast Cancer
Official title: Prospective Assessment of Disease Progression in Primary Breast Cancer Patients Undergoing EndoPredict® Gene Expression Testing - a Care Research Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Invasive Breast Cancer
Estrogen Receptor Positive Tumor
Human Epidermal Growth Factor Receptor 2 Negative Tumor
Keywords: breast cancer
EndoPredict®
endocrine therapy
Lead sponsor: North Eastern German Society of Gynaecological Oncology
Sponsor class: OTHER
Collaborators: name: Center for Clinical Trials Philipps University Marburg
First posted: 2018-04-20
Enrollment: 1191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary stage I or Ii breast cancer who met all inclusin and no exclusion criteria

Brief summary: Systematic assessment of survival data of patients who have been tested with EndoPredict®; prospective proof that patients with low risk classification by EndoPredict® (EPclin) can safely forgo chemotherapy and be treated with endocrine therapy alone.

Detailed description: The goal of the study is to receive current and comprehensive information about the diseasefree (remote metastasis free and recurrence free) interval of EndoPredict® low risk patients.

The study is organized and managed by the NOGGO e.V. (North Eastern German Society of Gynaecological Oncology e.V.) study coordination office under the existing and efficient infrastructure. All patients who receive gene expression analysis with EndoPredict® and satisfy the remaining inclusion / exclusion criteria may participate in the study. Data collection is prospective and non-interventional. The recruitment of the required patients is expected to take a maximum of 36 months .

It must be emphasized that the study is data collection only and not an interventional study. This means that the choice and implementation of the therapy as well as the treatment assessments and frequency during and after the treatment can only be determined by the Investigator.

The decision to participate in the study is independent of the patient´s therapy within the framework of a study. Patient data will be recorded at the time of inclusion and once a year thereafter. Patient follow-up will be by phone from the second year onward.

Primary objective is to show that female patients who have been tested as "low risk" by EPclin and have been treated with endocrine therapy only for at least 5 years have a 10-year DMFS rate \> 90% (lower boundary of the one-sided 95% confidence interval).

Secondary objectives comprise the evaluation of DMFS (distant metastasis free survival) , DFS (disease free survival) and OS (overall survival) rates at different time points and for different groups. Assessment of the given chemotherapy regimens and the given endocrine therapy will be performed and the proportions of patients will be determined with respect to the received treatment and its duration in different groups. Furthermore, the proportion of patients in whom the tumor board recommendation follows the EndoPredict® result and the proportion of patients actually treated according to EndoPredict® result will be determined.

The association between outcome and treatment, EPclin, EP, and classical prognostic factors will be investigated in different groups of patients. The correlation and concordance between EPclin calculations derived from biopsies and surgical specimens will be assessed.

Eligibility criteria: Inclusion Criteria:

1. Informed consent
2. Tested with EndoPredict within the previous 6 months before inclusion
3. Age ≥ 18 years
4. Patients with primary invasive breast cancer, Stage I/II
5. ER-positive
6. HER2-negative
7. N0 or N1 (1-3 positive lymph nodes)
8. T1 - T3

Exclusion Criteria:

1. Inflammatory breast cancer
2. Bilateral breast cancer
3. Breast cancer in the last 10 years
4. Other invasive malignancies in the last 5 years

Primary outcomes:
measure: Distant metastasis free survival
timeFrame: 10 years
Secondary outcomes:
measure: DMFS "low risk"
timeFrame: 3, 5 and 10 years
measure: DFS "low risk"
timeFrame: 3, 5 and 10 years
measure: OS "low risk"
timeFrame: 3, 5 and 10 years
measure: DMFS "high risk"
timeFrame: 3, 5 and 10 years
measure: DFS "high risk"
timeFrame: 3, 5 and 10 years
measure: OS "high risk"
timeFrame: 3, 5 and 10 years
measure: DMFS "high risk + low risk"
timeFrame: 3, 5 and 10 years
measure: DFS "high risk + low risk"
timeFrame: 3, 5 and 10 years
measure: OS "high risk + low risk"
timeFrame: 3, 5 and 10 years
measure: Portion of patients tumor board follows the EndoPredict® result
timeFrame: 1 year
measure: Portion of patient treated according EndoPredict® result
timeFrame: 1 year
measure: Prognostic Performance of classical prognostic factors compared to EndoPredict®
timeFrame: 3, 5 and 10 years
measure: DMFS "low risk vs. high risk"
timeFrame: 3, 5 and 10 years
measure: DFS "low risk vs. high risk"
timeFrame: 3, 5 and 10 years
measure: OS "low risk vs. high risk"
timeFrame: 3, 5 and 10 years
measure: DMFS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors
timeFrame: 3, 5 and 10 years
measure: DFS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors
timeFrame: 3, 5 and 10 years
measure: OS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors
timeFrame: 3, 5 and 10 years
measure: DMFS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines
timeFrame: 3, 5 and 10 years
measure: DFS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines
timeFrame: 3, 5 and 10 years
measure: OS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines
timeFrame: 3, 5 and 10 years
measure: Chemotherapy regimens
timeFrame: 1 year
measure: Given endocrine therapy
timeFrame: 10 years
measure: Duration of endocrine therapy
timeFrame: 10 years
measure: Proportion of patients with prolonged endocrine therapy
timeFrame: 10 years
measure: DMFS for patients with 5 years of endocrine therapy vs. extended endocrine therapy
timeFrame: 10 years
measure: DFS for patients with 5 years of endocrine therapy vs. extended endocrine therapy
timeFrame: 10 years
measure: OS for patients with 5 years of endocrine therapy vs. extended endocrine therapy
timeFrame: 10 years
measure: Correlation ( pT- and pN data vs. ciT and ciN-data)
timeFrame: 1 year
measure: Concordance ( pT- and pN data vs. ciT and ciN-data)
timeFrame: 1 year
Other outcomes:
Locations:
city: München
country: Germany
facility: Frauenklinik der Technischen Universität München
state: Bayern
city: Ansbach
country: Germany
facility: ANregiomed Ansbach
city: Berlin-Mitte
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban
city: Berlin
country: Germany
facility: DRK Kliniken Köpenick
city: Berlin
country: Germany
facility: MVZ Hellersdorf - Zweigstelle Biesdorf
city: Berlin
country: Germany
facility: Park-Klinik Weißensee
city: Berlin
country: Germany
facility: Helios Klinikum Berlin Buch
city: Bremerhaven
country: Germany
facility: Klinikum Bremerhaven Reinkenheide
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dresden
country: Germany
facility: Krankenhaus St. Joseph Stift Dresden GmbH
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Ebersberg
country: Germany
facility: Kreisklinik Ebersberg
city: Erding
country: Germany
facility: Klinikum Erding
city: Fürstenwalde
country: Germany
facility: Praxis Dr. Heinrich
city: Halle
country: Germany
facility: Krankenhaus St. Elisabeth und St. Barbara
city: Hamburg
country: Germany
facility: Krankenhaus Jerusalem
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Herford
country: Germany
facility: Mathilden Hospital
city: Hildesheim
country: Germany
facility: Frauenärzte am Bahnhofsplatz
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Koblenz
country: Germany
facility: Gemeinschaftsklinikum Mittelrhein gGmbH Kemperhof
city: Landshut
country: Germany
facility: VK & K Studien GbR
city: Magdeburg
country: Germany
facility: Krankenhaus St. Marienstift
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg gGmbH
city: Marktredwitz
country: Germany
facility: Klinikum Fichtelgebirge
city: München
country: Germany
facility: Gemeinschaftspraxis Gynäkologie Arabella
city: Oranienburg
country: Germany
facility: Oberhavel Kliniken GmbH
city: Pinneberg
country: Germany
facility: Regioklinik Pinneberg
city: Potsdam
country: Germany
facility: Ernst von Bergmann Klinikum
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Traunstein
country: Germany
facility: Klinikum Traunstein
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromäerinnen gGmbH
city: Wernigerode
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal
city: Bern
country: Switzerland
facility: Brustzentrum Bern Lindenhofgruppe
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Zürich
country: Switzerland
facility: Spital Zollikerberg
Study officials:
affiliation: TU München (TUM) Lehrstuhl für Gynäkologie und Geburtshilfe
name: Marion Kiechle, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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