NCT04111978RecruitingPhase 3
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer: a Randomized Double-blinded Placebo-controlled Multi-centre Phase III Trial (ENGOT-ov54/Swiss-GO-2/MATAO), Including LOGOS (Low Grade Ovarian Cancer Sub-study).
Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy of addition of letrozole to the standard maintenance therapy in subjects following a primary diagnosis of Estrogen-receptor (ER) positive high and low grade epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) and subsequent primary treatment surgery and chemotherapy. Half of the participants will receive to the standard maintenance treatment, letrozole, whilst the other half receives placebo. The study's primary hypothesis is that the treatment with letrozole increases progression free survival in comparison to the maintenance standard treatment (superiority trial).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 540 (estimated)
- First submitted
- 30 Sept 2019
- Start date
- 5 Nov 2020
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Swiss GO Trial Group
- Diseases
- Ovarian cancer
- NCT number
- NCT04111978
- EU CT number
- 2024-511219-78-00
- EudraCT number
- 2019-002264-27
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 540
- From 5 Nov 2020 to the primary completion date, 1 Jul 2027
- 53 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women of childbearing potential (not having undergone a surgical or radiation sterilization and not getting a surgical resection, prior to the intervention in the therapeutical maintenance setting)
- \< 4 cycles of chemotherapy in total
- Contraindications to endocrine therapy
Other illness
- Progressive disease at the end of adjuvant treatment as defined in chapter 9.2.1 of protocol
- Any other malignancy within the last 5 years which has impact on the prognosis of the patient
Lab values
- Patients with a known intolerance to galactose, lactase deficiency and glucose-galactose malabsorption
Other
- Pregnant or lactating women
- Inability or unwillingness to swallow tablets
Who the study is looking for
- Patients must be ≥ 18 years of age
- Willing and able to attend the visits and to understand all study-related procedures.
- Primary, newly diagnosed FIGO Stage II to IV and histologically confirmed low or high grade serous or endometrioid epithelial ovarian/fallopian tube/peritoneal cancer
- (Interval-) debulking performed ECOG-Performance Status 0-2
- Signed informed consents (ICF-1; ICF-2)
- Paraffin-embedded tissue or paraffin-embedded cell block (from ascites) available
- Positivity (≥ 1%) for ER expression (only determined by Histopathology Core Facility of MATAO trial)
- At least 4 cycles of platinum-based chemotherapy (neoadjuvant allowed)
- Negative serum pregnancy test in women of childbearing potential who will get/have gotten a surgical resection or radiation sterilization, prior to the intervention in the therapeutical maintenance setting.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (53)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Krankenhaus Der Barmherzigen Brueder Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Steiermaerkische Krankenanstalten Ges.m.b.H. Coordinator of this site? Confirm its status | Leoben | Austria | Recruiting |
| Krankenhaus Der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Klinik Hietzing Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Kantonsspital Aarau AG Coordinator of this site? Confirm its status | Aarau | Switzerland | Recruiting |
| Kantonsspital Baden AG Coordinator of this site? Confirm its status | Baden | Switzerland | Recruiting |
| Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Basel Claraspital AG Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Oncology Institute of Southern Switzerland (IOSI)-Ente Ospedaliero Cantonale (EOC) Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Recruiting |
| Praxis im Frauenzentrum Lindenhofspital Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Universitätsklinik für Medizinische Onkologie, Inselspital Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Kantonspital Graubünden (KSGR), Coordinator of this site? Confirm its status | Chur | Switzerland | Recruiting |
| Kantonsspital Frauenfeld Coordinator of this site? Confirm its status | Frauenfeld | Switzerland | Recruiting |
| Hôpitaux universitaires de Genève Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
| Frauenklinik Spital Grabs Coordinator of this site? Confirm its status | Grabs | Switzerland | Recruiting |
| Universitätsspital Waadt/ CHUV Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
| Kantonsspital Baselland Coordinator of this site? Confirm its status | Liestal | Switzerland | Recruiting |
| Tumorzentrum Hirslanden Klinik St. Anna Coordinator of this site? Confirm its status | Lucerne | Switzerland | Recruiting |
| Luzerner Kantonsspital Coordinator of this site? Confirm its status | Lucerne | Switzerland | Recruiting |
| Kantonsspital Münsterlingen Coordinator of this site? Confirm its status | Münsterlingen | Switzerland | Recruiting |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Centre Hospitalier du Valais Romand Coordinator of this site? Confirm its status | Sion | Switzerland | Recruiting |
| Kantonsspital Winterthur Coordinator of this site? Confirm its status | Winterthur | Switzerland | Recruiting |
| Stadtspital Triemli Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Unispital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Klinik für Onkologie und Hämatologie Hirslanden Zürich AG Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| St. Elisabeth Krankenhaus GmbH Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU Coordinator of this site? Confirm its status | Deggendorf | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Recruiting |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Klinikum Esslingen GmbH Coordinator of this site? Confirm its status | Esslingen am Neckar | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Agaplesion Diakonieklinikum Hamburg gGmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Frauenaerzte Am Bahnhofsplatz Coordinator of this site? Confirm its status | Hildesheim | Germany | Recruiting |
| Klinikum Konstanz GmbH Coordinator of this site? Confirm its status | Konstanz | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Universitaetsklinikum Mannheim GmbH Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| MVZ fuer Haematologie und Onkologie Ravensburg GmbH Coordinator of this site? Confirm its status | Ravensburg | Germany | Recruiting |
| RoMed Klinikum Rosenheim Coordinator of this site? Confirm its status | Rosenheim | Germany | Recruiting |
| Leopoldina Krankenhaus der Stadt Schweinfurt GmbH Coordinator of this site? Confirm its status | Schweinfurt | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Coordinator of this site? Confirm its status | Wiesbaden | Germany | Recruiting |
| Klinikum Wolfsburg Coordinator of this site? Confirm its status | Wolfsburg | Germany | Recruiting |
| Helios Universitaetsklinikum Wuppertal Coordinator of this site? Confirm its status | Wuppertal | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.