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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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).

MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO) (NCT04111978) is a Phase 3 interventional studying Ovarian Neoplasm Epithelial and Fallopian Tube Neoplasms, sponsored by Swiss GO Trial Group. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Ovarian Neoplasm Epithelial, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 540 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 diagnosed by tissue sample (biopsy-confirmed) low or high grade serous or endometrioid epithelial ovarian/fallopian tube/peritoneal cancer - (Interval-) debulking performed ECOG-Performance Status 0-2 - Signed willing to sign a consent forms (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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Letrozole 2.5mg

Aromatase inhibitor

OTHER

Placebo

Placebo tablet of Femara

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Krankenhaus der Barmherzigen Brüder Graz
Graz, Austria
Medizinische Universität Graz
Graz, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
Landeskrankenhaus Hochsteiermark Leoben
Leoben, Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria
Universitätsklinikum Salzburg
Salzburg, Austria
Medizinische Universität Wien
Vienna, Austria
Klinik Hietzing Wien
Vienna, Austria
Charité - Universitätsmedizin Berlin Campus Virchow Klinikum
Berlin, Germany
St. Elisabeth-Krankenhaus
Cologne, Germany
Donauisar Klinikum
Deggendorf, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Evangelische Kliniken Essen Mitte GmbH
Essen, Germany
Klinikum Esslingen
Esslingen am Neckar, Germany
University Hospital Freiburg
Freiburg im Breisgau, Germany
The University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Agaplesion Diakonieklinikum Hamburg
Hamburg, Germany
Gynäkologisch-Onkologische Gemeinschaftspraxis Dres. med. C.Uleer/J.Y.Pourfard
Hildesheim, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04111978), the sponsor (Swiss GO Trial Group), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04111978 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04111978?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04111978?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04111978. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04111978. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.