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NCT04111978Recruiting

MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)

Official recordSimplified version

Summary

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).

Inclusion criteria

• 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.

Exclusion criteria

• Progressive disease at the end of adjuvant treatment as defined in chapter 9.2.1 of protocol • 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) • Pregnant or lactating women • Any other malignancy within the last 5 years which has impact on the prognosis of the patient • \< 4 cycles of chemotherapy in total • Contraindications to endocrine therapy • Inability or unwillingness to swallow tablets • Patients with a known intolerance to galactose, lactase deficiency and glucose-galactose malabsorption

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 3
Study type
Interventional
Countries
Switzerland, Germany, Austria
Sponsor
Swiss GO Trial Group(Network / cooperative)
Protocol no.
ENGOT-ov54/Swiss-GO-2/MATAO
Conditions
Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms, Peritoneal Neoplasms, High-grade Serous Ovarian Carcinoma (HGSOC), Low-grade Serous Ovarian Carcinoma (LGSOC), Ovarian Endometrioid Carcinoma
Interventions
Drug, Other

Treatments studied

  • Letrozole 2.5mg
  • Placebo

Collaborators

AGO Study Group, Arbeitsgemeinschaft Gynaekologische Onkologie Austria, Reliable Cancer Therapies, Krebsliga Schweiz, Stiftung Guido Feger, Hoffmann-La Roche, Helsana AG, Novartis Pharmaceuticals, Anticancer Fund, Belgium

Locations · 51

  • Aarau, SwitzerlandKantonsspital Aarau AGRecruiting at this site
  • Basel, SwitzerlandUniversitätsspital BaselRecruiting at this site
  • Bellinzona, SwitzerlandOncology Institute of Southern Switzerland (IOSI)-Ente Ospedaliero Cantonale (EOC)Recruiting at this site
  • Sion, SwitzerlandCentre Hospitalier du Valais RomandRecruiting at this site
  • Baden, SwitzerlandKantonsspital Baden AGRecruiting at this site
  • Basel, SwitzerlandBasel Claraspital AGRecruiting at this site
  • Bern, SwitzerlandUniversitätsklinik für Medizinische Onkologie, InselspitalRecruiting at this site
  • Bern, SwitzerlandPraxis im Frauenzentrum LindenhofspitalRecruiting at this site
  • Chur, SwitzerlandKantonspital Graubünden (KSGR),Recruiting at this site
  • Frauenfeld, SwitzerlandKantonsspital FrauenfeldRecruiting at this site
  • Geneva, SwitzerlandHôpitaux Universitaires de GenèveRecruiting at this site
  • Grabs, SwitzerlandFrauenklinik Spital GrabsRecruiting at this site
  • Lausanne, SwitzerlandUniversitätsspital Waadt/ CHUVRecruiting at this site
  • Liestal, SwitzerlandKantonsspital BasellandRecruiting at this site
  • Lucerne, SwitzerlandLuzerner KantonsspitalRecruiting at this site
  • Lucerne, SwitzerlandTumorzentrum Hirslanden Klinik St. AnnaRecruiting at this site
  • Münsterlingen, SwitzerlandKantonsspital MünsterlingenRecruiting at this site
  • Sankt Gallen, SwitzerlandKantonsspital St. GallenRecruiting at this site
  • Winterthur, SwitzerlandKantonsspital WinterthurRecruiting at this site
  • Zurich, SwitzerlandKlinik für Onkologie und Hämatologie Hirslanden Zürich AGRecruiting at this site
  • Zurich, SwitzerlandStadtspital TriemliRecruiting at this site
  • Zurich, SwitzerlandUnispital ZürichRecruiting at this site
  • Berlin, GermanyCharité - Universitätsmedizin Berlin Campus Virchow KlinikumRecruiting at this site
  • Cologne, GermanySt. Elisabeth-KrankenhausRecruiting at this site
  • Deggendorf, GermanyDonauisar KlinikumRecruiting at this site
  • Düsseldorf, GermanyEvangelisches Krankenhaus DüsseldorfRecruiting at this site
  • Düsseldorf, GermanyUniversitätsklinikum DüsseldorfRecruiting at this site
  • Essen, GermanyEvangelische Kliniken Essen Mitte GmbHRecruiting at this site
  • Esslingen am Neckar, GermanyKlinikum EsslingenRecruiting at this site
  • Freiburg im Breisgau, GermanyUniversity Hospital FreiburgRecruiting at this site

In total, worldwide, 51 of the 53 sites listed in the registry are recruiting; the other 2 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: September 29, 2025).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 21 more locations

Other identifiers

  • 2024-511219-78-00 · CTIS number
  • 2019-002264-27 · EudraCT number
  • ENGOT-ov54 · other identifier
  • Swiss-GO-2 · other identifier
  • AGO-OVAR 26 · other identifier
  • AGO 65 · other identifier
  • 2019 · NIH grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.