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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms, Peritoneal Neoplasms, High-grade Serous Ovarian Carcinoma (HGSOC), Low-grade Serous Ovarian Carcinoma (LGSOC), Ovarian Endometrioid Carcinoma

In brief

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).

Key facts

Study ID

NCT04111978

Run by

Swiss GO Trial Group

People needed

540

Starts

2020-11-05

Expected to finish

2032-07-01

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Medizinische Universität Graz — Graz, Austria (enrolling)
• Krankenhaus der Barmherzigen Brüder Graz — Graz, Austria (enrolling)
• Landeskrankenhaus Hochsteiermark Leoben — Leoben, Austria (enrolling)
• Ordensklinikum Linz Barmherzige Schwestern — Linz, Austria (enrolling)
• Medizinische Universität Innsbruck — Innsbruck, Austria (enrolling)
• Medizinische Universität Wien — Vienna, Austria (enrolling)
• Klinik Hietzing Wien — Vienna, Austria (enrolling)
• Charité - Universitätsmedizin Berlin Campus Virchow Klinikum — Berlin, Germany (enrolling)
• St. Elisabeth-Krankenhaus — Cologne, Germany (enrolling)
• Donauisar Klinikum — Deggendorf, Germany (enrolling)
• Universitätsklinikum Salzburg — Salzburg, Austria (enrolling)
• Evangelisches Krankenhaus Düsseldorf — Düsseldorf, Germany (enrolling)
• Universitätsklinikum Düsseldorf — Düsseldorf, Germany (enrolling)
• Evangelische Kliniken Essen Mitte GmbH — Essen, Germany (enrolling)
• Klinikum Esslingen — Esslingen am Neckar, Germany (enrolling)
• University Hospital Freiburg — Freiburg im Breisgau, Germany (enrolling)
• The University Medical Center Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Agaplesion Diakonieklinikum Hamburg — Hamburg, Germany (enrolling)
• Gynäkologisch-Onkologische Gemeinschaftspraxis Dres. med. C.Uleer/J.Y.Pourfard — Hildesheim, Germany (enrolling)
• Klinikum Konstanz — Konstanz, Germany (enrolling)
• Universitätsmedizin Mainz — Mainz, Germany (enrolling)
• Universitätsklinikum Mannheim — Mannheim, Germany (enrolling)
• University Hospital Münster — Münster, Germany (enrolling)
• Studienzentrum Onkologie Ravensburg — Ravensburg, Germany (enrolling)
• Leopoldina Krankenhaus der Stadt Schweinfurt — Schweinfurt, Germany (enrolling)

Full record on ClinicalTrials.gov

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