Spots Global Cancer Trial Database for Genotype and Phenotype Guided Supplementation of TAMoxifen Standard Therapy With ENDOXifen in Breast Cancer Patients
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Trial Identification
Brief Title: Genotype and Phenotype Guided Supplementation of TAMoxifen Standard Therapy With ENDOXifen in Breast Cancer Patients
Official Title: Genotype and Phenotype Guided Supplementation of TAMoxifen Standard Therapy With ENDOXifen in Breast Cancer Patients (TAMENDOX)
Study ID: NCT03931928
Study Description
Brief Summary: In hormone-receptor positive breast cancer or DCIS (ductal carcinoma in situ) tamoxifen remains an important treatment option for patients before menopause and those patients after menopause who cannot be treated with aromatase-inhibitors. Nonetheless, a considerable amount of patients suffer a relapse of their cancer while on treatment with tamoxifen. Tamoxifen is a drug that is metabolized to a variety of compounds by the human liver, and the most important antihormonally active metabolite is called (Z)-Endoxifen. It is known that patients who have a reduced or absent activity of the drug-metabolizing enzyme CYP2D6 have lower levels of (Z)-Endoxifen. Furthermore, it has been observed that patients on tamoxifen therapy who have absent CYP2D6 activity are at a 2-fold increased risk for disease recurrence, and patients with lower CYP2D6 compared to patients with normal CYP2D6 activity still have a 1.4-fold increased risk for disease recurrence. This trial will include patients who are already on tamoxifen therapy for at least 3 months and is designed to show that in patients with absent or low CYP2D6 activity, (Z)-Endoxifen supplementation - that is giving (Z)-Endoxifen in addition to tamoxifen for the study period of 42 days - can increase blood levels of (Z)-Endoxifen to therapeutic concentrations. It is planned to included 504 patients in this blinded, randomized trial, which will have a placebo group (receiving no (Z)-Endoxifen) and two intervention groups that will receive 0, 1.5 or 3 mg (Z)-Endoxifen depending on their CYP2D6 genetics or their (Z)-Endoxifen levels at the start of the study. The trial is not designed to evaluate outcome measures (that is recurrence or survival rates) of (Z)-Endoxifen supplementation in tamoxifen treated patients, but will document the safety of the combined administration of tamoxifen and (Z)-Endoxifen.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Gemeinschaftspraxis für Gynäkologie und Geburtshilfe Salzgitter, Salzgitter, Albert-Schweitzer-Straße 18, Germany
Zentralklinikum Suhl, Klinik für Frauenheilkunde/Geburtsmedizin, Zentrum für klinische Studien, Suhl, Albert-Schweitzer-Straße 2, Germany
Rems-Murr-Klinikum-Winnenden, Frauenklinik, Winnenden, Am Jakobsweg 1, Germany
Robert-Bosch-Krankenhaus, Stuttgart, Auerbachstr. 112, Germany
Onkologische Gemeinschaftspraxis Hildesheim, Gynäkologie, Hildesheim, Bahnhofsplatz 5, Germany
Johanniter-Krankenhaus Stendal, Klinik für Frauenheilkunde und Geburtshilfe, Stendal, Bahnhofstr. 24-26, Germany
Klinikum Magdeburg, Klinik für Hämatologie/Onkologie, Magdeburg, Birkenallee 34, Germany
Klinikum Memmingen, Brustzentrum, Memmingen, Bismarckstraße 23, Germany
Klinikum am Bruderwald Bamberg, Hämatologie/Internistische Onkologie, Bamberg, Buger Straße 80, Germany
MVZ am Klinikum am Bruderwald Bamberg, Bamberg, Buger Straße 80, Germany
Universitätsfrauenklinik Tübingen, Tübingen, Calwer Straße 7, Germany
Helios Klinikum Gifhorn, Interdisziplinäres Brustzentrum, Gifhorn, Campus 6, Germany
ViDiA Christliche Kliniken Karlsruhe, Frauenklinik, Karlsruhe, Diakonissenstr.28, Germany
Klinikum Quedlinburg, Frauenklinik, Quedlinburg, Ditfurter Weg 24, Germany
Klinikum Höchst Frankfurt am Main, Klinik für Gynäkologie und Geburtshilfe, Frankfurt am Main, Gotenstr. 6-8, Germany
Evangelisches Diakonie-Krankenhaus Bremen, Frauenklinik, Bremen, Gröpelinger Heerstraße 406-408, Germany
Onkologische Gemeinschaftspraxis Brudler-Heinrich-Bangerter Augsburg, Augsburg, Halderstraße 29, Germany
medius Klinik Ostfildern-Ruit, Brustzentrum, Ostfildern, Hedelfingerstraße 166, Germany
Helios Universitätsklinikum Wuppertal GmbH, Brustzentrum, Wuppertal, Heusnerstraße 40, Germany
Klinikum Esslingen, Klinik für Frauenheilkunde, Brustzentrum, Esslingen, Hirschlandstraße 97, Germany
SRH Kliniken Sigmaringen, Gynäkologie und Geburtshilfe, Sigmaringen, Hohenzollerstr. 40, Germany
Harz-Klinikum Wernigerode, Abteilung Gynäkologie und Geburtshilfe, Wernigerode, Ilsenburger Straße 15, Germany
Klinikum Passau, Gynäkologische Onkologie, Passau, Innstraße 76, Germany
St. Johannes Hospital Dortmund, Klinische Forschung, Dortmund, Johannesstraße 9-17, Germany
Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe, Bottrop, Josef-Albers-Straße 70, Germany
Universitätsfrauenklinik Mainz, Klinik und Poliklinik für Geburtshilfe und Frauenheilkunde, Mainz, Langenbeckstr. 1, Germany
Onkozentrum Dresden, Fachärzte für Innere Medizin, Hämatologie und Internistische Onkologie, Dresden, Leipziger Straße 120, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden, Klinik für Gynäkologie und gyn. Onkologie, Wiesbaden, Ludwig-Erhard-Straße 100, Germany
Luisenkrankenhaus Düsseldorf GmbH & Co. KG, Brustzentrum, Düsseldorf, Luise-Rainer-Straße 6-10, Germany
Marienhospital Witten, Brustzentrum, Witten, Marienplatz 2, Germany
Städtisches Klinikum Karlsruhe, Frauenklinik, Karlsruhe, Moltkestr. 90, Germany
Kliniken der Stadt Köln, Brustzentrum Köln-Holweide, Köln, Neufelder Straße 32, Germany
Diakonissen-Krankenhaus Speyer, Klinik für Gynäkologie und Geburtshilfe, Speyer, Paul-Egell-Straße 33, Germany
Klinikum Ludwigsburg, Frauenklinik, Ludwigsburg, Posilipostraße 4, Germany
DRK Kliniken Berlin-Köpenick, Frauenklinik, Berlin Köpenick, Salvador-Allende-Straße 2-8, Germany
MVZ Eggenfelden, Gynäkologische Onkologie, Eggenfelden, Schellenbruckerstr. 15, Germany
Klinikum am Steinenberg Reutlingen, Frauenklinik, Reutlingen, Steinenbergstr. 31, Germany
SRH Wald-Klinikum Gera GmbH, Klinik für Frauenheilkunde/Geburtsmedizin, Gera, Straße Des Friedens 122, Germany
Elisabeth Krankenhaus Kassel gGmbH, Brustzentrum, Kassel, Weinbergstr. 7, Germany
MVZ am Schlosssee Gifhorn, Gifhorn, Zur Allerwelle 4, Germany
Contact Details
Name: Matthias Schwab, Prof. Dr.
Affiliation: Margarete Fischer-Bosch-Institute of Clinical Pharmacology
Role: PRINCIPAL_INVESTIGATOR
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