Ovarian Neoplasm EpithelialPhase 3MATAONCT04111978
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
A Phase 3 study testing Letrozole 2.5mg in people with Ovarian Neoplasm Epithelial and Fallopian Tube Neoplasms, run by Swiss GO Trial Group at 53 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms, Peritoneal Neoplasms
- What is being tested?
- Letrozole 2.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 53 sitesin 3 countries
- Study dates
- 5 Nov 2020to 1 Jul 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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 cannot join
- 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
Trial locations and contacts
53 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
53 sites in 3 countries
Germany23 sites, 21 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin Campus Virchow Klinikum
Berlin, 13353
Radoslav Chekerov, PD Dr med, +49 30 450 664 399, radoslav.chekerov@charite.de
Klaus Pietzner, PD Dr med, +49 30 450 664 386, klaus.pietzner@charite.de
- Recruiting
St. Elisabeth-Krankenhaus
Cologne, 50935
Daniel Rein, Prof Dr med, +49 221 4677 1301, daniel.rein@hohenlind.de
Christin Traut, MD, +49 221 4677 1312, christin.traut@hohenlind.de
- Recruiting
Donauisar Klinikum
Deggendorf, 94469
Sara Tato-Varela, Dr. med., +49 991 380 3158, sara.tato-varela@donau-isar-klinikum.de
Walter Kuhn, Prof.Dr.med., +49 991 380 3151, walther.kuhn@donau-isar-klinikum.de
- Active, not recruiting
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
- Recruiting
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217
Carolin Nestle-Krämling, Dr med, +49 211 919 483 542, carolin.nestle-kraemling@evk-duesseldorf.de
Eleni Tsepelidou, Dr med, +49 211 919 1021, eleni.tsepelidou@evk-duesseldorf.de
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Tanja Fehm, Prof. Dr., +49 211 8117501, tanja.fehm@med.uni-duesseldorf.de
Eugen Ruckhäberle, Prof. Dr., +49(0)211 8108087, eugen.ruckhaeberle@med.uni-duesseldorf.de
- Recruiting
Evangelische Kliniken Essen Mitte GmbH
Essen, 45136
Julia Welz, Dr. med., +49 201 17434531, j.welz@kem-med.com
Philipp Harter, Prof Dr med., +49 201 174-34021, p.harter@kem-med.com
- Recruiting
Klinikum Esslingen
Esslingen am Neckar, 73730
Alexander Hein, PD Dr med, +49 711 3103 3051, a.hein.cto@klinikum-esslingen.de
Bettina Braun, Dr med, +49 711 3103 3051, b.braun@klinikum-esslingen.de
- Recruiting
University Hospital Freiburg
Freiburg im Breisgau, 79106
Maximillian Klar, Prof Dr med, +49 761 270-31680, Maxmaximilian.klar@uniklinik-freiburg.de
Florin-Andrei Taran, Prof Dr med, : +49 761 270-77112, florin-andrei.taran@uniklinik-freiburg.de
- Recruiting
The University Medical Center Hamburg-Eppendorf
Hamburg, 20251
Anna Jaeger, Dr., +49 (0) 40 7410 - 23800, a.jaeger@uke.de
- Recruiting
Agaplesion Diakonieklinikum Hamburg
Hamburg, 20259
Mustafa Celalettin Ugur, Dr med, celal.ugur@agaplesion.de
Kirsten Graubner, Dr med, kirsten.graubner@agaplesion.de;
- Recruiting
Gynäkologisch-Onkologische Gemeinschaftspraxis Dres. med. C.Uleer/J.Y.Pourfard
Hildesheim, 31134
Christoph Uleer, Dr med, +49 512 1590 247, c.uleer@gmx.de
Jasmin Pourfard, Dr med, +49 512 1590 247, j.pourfard@gmx.de
- Recruiting
Klinikum Konstanz
Konstanz, 78464
Andreas Zorr, Dr med, +49 7531 801 1601, andreas.zorr@glkn.de
Kristina Bätge, MD, +49 7531 801 1616, kristina.baetge@glkn.de
- Recruiting
Universitätsmedizin Mainz
Mainz, 55131
Marco Battista, Dr., battist@uni-mainz.de
Martina Seehase, +49 6131-173291, Martina.Seehase@unimedizin-mainz.de
- Recruiting
Universitätsklinikum Mannheim
Mannheim, 68167
Frederik Marmé, Dr., +49 621 3838215, frederik.marme@umm.de
Athanasios Mavratzas, Dr., +49 621 3831476, athanasios.mavratzas@umm.de
- Recruiting
University Hospital Münster
Münster, 48149
Ralph Witteler, Dr med, +49 251 83 48236, ralf.witteler@ukmuenster.de
Sebastian Schäfer, Dr med, +49 251 83 44107, sebastiandaniel.schaefer@ukmuenster.de
- Recruiting
Studienzentrum Onkologie Ravensburg
Ravensburg, 88212
Martina Gropp-Meier, Dr. med., +497513661970, matrina.gropp-meier@oberschwabenklinik.de
Thomas Decker, Prof Dr med., +49 751 3661970, thomas.decker@onkonet.eu
- Active, not recruiting
SL Klinikum Rosenheim
Rosenheim, 83022
- Recruiting
Leopoldina Krankenhaus der Stadt Schweinfurt
Schweinfurt, 97422
Michael Weigel, Prof, +4997217202132, mweigel@leopoldina.de
Elke Wiegand, Dr. med., +4997217202132, ewiegand@leopoldina.de
- Recruiting
Universitätsklinik Ulm
Ulm, 89075
Fabienne Schochter, Dr. med, 0731 500-58900, fabienne.schochter@uniklinik-ulm.de
- Recruiting
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, 65199
Michael Eichbaum, Prof Dr med, +49 611 432 377, michael.eichbaum@helios-gesundheit.de
Tatjana Cordes, Dr med, +49 611/433234, tatjana.cordes@helios-gesundheit.de
- Recruiting
AMO Wolfsburg / AMO MVZ GmbH
Wolfsburg, 38440
clemens Liebrich, Dr med, +49 536 180 3813, clemens.liebrich@klinikum.wolfsburg.de
Vanessa Zahn, MD, +49 536 180 3813, vanessa.zahn@klinikum.wolfsburg.de
- Recruiting
Helios Universitätsklinikum Wuppertal
Wuppertal, 42117
Markus Fleisch, Prof. Dr., +49 202 896 1400, markus.fleisch@helios-gesundheit.de
Vesna Bjelic-Radisic, Prof. Dr., +49 202 896 1411, vesna.bjelic-radisic@helios-gesundheit.de
Switzerland22 sites, 22 recruiting
- Recruiting
Kantonsspital Aarau AG
Aarau, Canton of Aargau, 5001
Dimitri Sarlos, PD, +41 (0)62 838 5065, dimitri.sarlos@ksa.ch
- Recruiting
Kantonsspital Baden AG
Baden, 5404
Martin Heubner, Prof., +41 (0)56 486 3502, martin.heubner@ksb.ch
- Recruiting
Universitätsspital Basel
Basel, Canton of Basel-City, 4031
Viola Heinzelmann-Schwarz, Prof, +41 (0)61 265 58 83, viola.heinzelmann@usb.ch
- Recruiting
Basel Claraspital AG
Basel, 4002
Thomas Schmid, Dr. med., +41 (0)61 685 88 65, thomas.schmid@claraspital.ch
- Recruiting
Oncology Institute of Southern Switzerland (IOSI)-Ente Ospedaliero Cantonale (EOC)
Bellinzona, Canton Ticino, 6500
Ilaria Colombo, Dr med, +41 (0)91 811 81 94, ilaria.colombo@eoc.ch
- Recruiting
Universitätsklinik für Medizinische Onkologie, Inselspital
Bern, 3010
Julian Wampfler, MD PhD, +41 (0)31 632 4636, julian.wampfler@insel.ch
- Recruiting
Praxis im Frauenzentrum Lindenhofspital
Bern, 3012
Ralf Rothmund, Prof., +41 (0)31 300 85 80, ralf.rothmund@lindenhofgruppe.ch
- Recruiting
Kantonspital Graubünden (KSGR),
Chur, 7000
Michael Schwitter, Dr. med., +41 (0)81 256 66 46, Michael.Schwitter@ksgr.ch
- Recruiting
Kantonsspital Frauenfeld
Frauenfeld, 8501
Mathias Fehr, Prof., +41 (0)52 723 7255, mathias.fehr@stgag.ch
- Recruiting
Hôpitaux Universitaires de Genève
Geneva, 1205
Intidar Labidi-Galy, Dr. med., +41 (0)22 372 4014, intidhar.labidi-galy@hcuge.ch
- Recruiting
Frauenklinik Spital Grabs
Grabs, 9472
Seraina Schmid, PD, +41 (0)81 772 5410, seraina.schmid@srrws.ch
- Recruiting
Universitätsspital Waadt/ CHUV
Lausanne, 1011
Apostolos Sarivalasis, Dr. med., +41 (0)79 556 73 62, apostolos.sarivalasis@chuv.ch
- Recruiting
Kantonsspital Baselland
Liestal, 4410
Marcus Vetter, Dr. med., +41 61 925 2525, marcus.vetter@ksbl.ch
- Recruiting
Luzerner Kantonsspital
Lucerne, 6000
Stefan Aebi, Prof., +41 (0)41 205 5860, stefan.aebi@luks.ch
- Recruiting
Tumorzentrum Hirslanden Klinik St. Anna
Lucerne, 6006
Andreas Günthert, Prof, +41 (0)41 208 41 13, Andreas.guenthert@hin.ch
- Recruiting
Kantonsspital Münsterlingen
Münsterlingen, 8596
Christian Taverna, Dr. med., +41 (0)71 686 22 02, christian.taverna@stgag.ch
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, 9007
René Hornung, Prof., +41 (0)71 494 18 62, Rene.Hornung@kssg.ch
- Recruiting
Centre Hospitalier du Valais Romand
Sion, Valais
Marie-Gabrielle Courtès, Dr Med, +41 27 60 38 513, Marie-Gabrielle.Courtes@hopitalvs.ch
- Recruiting
Kantonsspital Winterthur
Winterthur, 8401
Andreas Müller, Dr. med., +41 (0)52 266 3644, andreas.mueller@ksw.ch
- Recruiting
Klinik für Onkologie und Hämatologie Hirslanden Zürich AG
Zurich, 8032
Anita Hirschi-Blickenstorfer, Dr. med., +41 (0)44 387 3761, anita.hirschi@kho.ch
- Recruiting
Stadtspital Triemli
Zurich, 8063
Natalie Gabriel, Dr. med., +41 (0)44 416 20 04, natalie.gabriel@triemli.zuerich.ch
- Recruiting
Unispital Zürich
Zurich, 8091
Eleftherios Pierre Samartzis, Dr., +41 (0)44 255 11 11, eleftherios.samartzis@usz.ch
Austria8 sites, 8 recruiting
- Recruiting
Krankenhaus der Barmherzigen Brüder Graz
Graz, 8020
Sevelda, +43 316 7067 13103
- Recruiting
Medizinische Universität Graz
Graz, 8036
Kolovetsiou- Kreiner MD, +43/316/385/80643
- Recruiting
Medizinische Universität Innsbruck
Innsbruck, 6020
Marth, +4350/504 23051
- Recruiting
Landeskrankenhaus Hochsteiermark Leoben
Leoben, 8700
Peternell
Maderdonner, +43 3842 401 3402
- Recruiting
Ordensklinikum Linz Barmherzige Schwestern
Linz, 4010
Judith Lafleur, Dr. med., +43 732 76777160, Judith.lafleur@ordensklinikum.at
- Recruiting
Universitätsklinikum Salzburg
Salzburg, 5020
Gerhard Bogner, PD. Dr. med., +43 5 7255 57964, g.bogner@salk.at
- Recruiting
Medizinische Universität Wien
Vienna, 1090
Stephan Polterauer, Assoc. Prof. Priv. Doz. Dr., +43140400 61091, Stephan.polterauer@meduniwien.ac.at
- Recruiting
Klinik Hietzing Wien
Vienna, 1130
Christian Peters-Engl, Dr., +43 1 80 110 2294, Christian.Peters-Engl@gesundheitsverbund.at
Petra Hnizdo, +43 180110 2170, kligynonko@hotmail.com
About this study
Official title: 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).
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).
Read the detailed description
Femara (letrozole) is an extensively investigated, marketed aromatase inhibitor (AI) widely used as treatment in the maintenance phase of estrogen-receptor (ER) positive breast cancer, as it inhibit the synthesis of estrogens. Estrogen is a well known driver of cancer growth in ER-positive tumors and a high percentage of the epithelial ovarian cancers express ER as well. Of which low grade ovarian cancers demonstrates the highest level of expression, supporting our strategy of a sub-group analysis (LOGOS). Therefore, letrozole in this study be investigated prospectively and evaluated as maintenance therapy after standard surgical and chemotherapy treatment in comparison to placebo (which is the current standard maintenance treatment) in subjects with primary, ER-positive low or high grade serous or endometrioid epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) of FIGO Stage II-IV, whose cancer has not progressed by the end of the platinum-based chemotherapy.
The objectives are to evaluate the letrozole maintenance treatment compared to placebo in terms of
- progression-free survival (PFS; primary endpoint)
- overall survival (OS)
- quality-adjusted progression free survival (QAPFS)
- time to first subsequent treatment (TFST)
- quality-adjusted time without symptoms of toxicity (Q-TWiST)
- health related quality of life (QoL) assessed by EQ-5D-5L, FACT-ES and FACT-O questionnaires
Methods: 540 for this study eligible subjects are 1:1 allocated in this randomized, controlled, double-blinded, multi-centre study to either the test (letrozole) or control (placebo) group. The maximum maintenance treatment duration is 5 years or until symptoms of toxicity or progression of underlying disease.
Health and health-related quality of life will continuously be assessed at study entry and during routine recalls which are scheduled every 12 weeks for the first 2 years, followed by every 24 weeks for the next 3 years. Procedures performed to assess the participants' health are the same as are performed during the regular routine ovarian cancer follow-up visits: blood tests, physical as well as gynaecological examinations and may include imaging. In addition, the participants are asked to complete during the study quality of life (QoL) specific questionnaires and wear an activity tracker for one week just before the scheduled visits. These assessments will be used for the evaluation of letrozole's efficacy and burden in comparison to the standard maintenance treatment. Survival follow-up data after the mainentance treatment duration of 5 years (study end) are obtained for up to another 7 years.
- Conditions
- Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms, Peritoneal Neoplasms, High-grade Serous Ovarian Carcinoma (HGSOC), Low-grade Serous Ovarian Carcinoma (LGSOC), Ovarian Endometrioid Carcinoma
- Being tested
- Letrozole 2.5mg, Placebo
- Keywords
- maintenance therapy, aromatase inhibitor, primary ovarian cancer, estrogen-receptor
- Medical subject headings
- Fallopian Tube Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole 2.5mgDrug
Also called Femara
Aromatase inhibitor
PlaceboOther
Placebo tablet of Femara
| Study group | Role | What they receive |
|---|---|---|
| Letrozole (aromatase inhibitor) | Experimental | Letrozole, 2.5 mg Femara tablet, administered once daily for 5 years or until symptoms of toxicity or progression of underlying disease Receives: Drug: Letrozole 2.5mg |
| Placebo | Placebo comparator | Placebo tablet of Femara (without aromatase inhibitor), 0 mg Femara tablet, administered once daily for 5 years or progression of underlying disease Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) for each study group
PFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression.
Assessment of progression (recurrence) is generally indicated by SYMPTOMS and will be assessed by the investigator most commonly on the basis of CT scans of the pelvis, abdomen and thorax, according to RECIST v1.1 criteria recommended and mostly presented by an elevated CA-125 level. Elevated CA-125 levels alone shouldn't be considered as progression. Progression assessment according to local standard of care, however, is similarly acceptable.
Measured: Up to approximately 12 years
Secondary outcomes (6)
Overall survival (OS) for each study group
OS defined for each patient as the time from the date of first IMP administration until the date of death from any cause. Patients not having an event at the time of analysis will be censored at the date they were last known to be alive.
Measured: Up to approximately 12 years
Quality-adjusted progression free survival (QAPFS) for each study group
QAPFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression under consideration of the quality of life during this period. QAPFS incorporates progression-free survival (quantity) and quality of life during this period into a measure of net clinical benefit:
QAPFS = PFS (years or months) x QoL (utility value).
Utility values derived from the EQ-5D-L5 questionnaire will be used.
Measured: Up to approximately 12 years
Time to first subsequent treatment (TFST) for each study group
TFST defined for each patient as the time from the date of first IMP administration until the date the patient started the next (second-line) subsequent anticancer treatment. Patients not receiving a subsequent anticancer treatment at the time of analysis will be censored at the date they were last known to be alive.
Measured: Up to approximately 12 years
Quality-adjusted time without symptoms of toxicity (Q-TWiST) for each study group
Q-TWiST defined as the Quality adjusted Time Without appearance of any Symptoms of Toxicity related to either the progression of the cancer or side effects of the trial medication from the date of first IMP administration until dead.
The Q-TWiST analysis considers the following three health states:
- (1) the period experiencing toxicity (TOX)
- (2) the period before progression without experiencing toxicity (TWiST)
- (3) the period after relapse (REL)
These periods are assigned preference utilities (u), which will be derived using the generic EQ-5D-5L questionnaire.
The Q-TWiST will be calculated as the weighted sum of the time spent in each health state:
Q-TWiST = uTox*TOX + TWiST + uRel*REL where u denotes the assigned utility for each respective health state.
Measured: Up to approximately 12 years
Health related quality of life (QoL) assessed byFunctional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire for each study group
Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) is included into the study to more specifically assess the side effects from the IMPs on quality of life. The minimum value is 0, the maximum value for the specific 19 item Endocrine Symptom Subscale (ESS-19) is 76. The higher the score, the better the QOL
Measured: Up to approximately 5.25 years
Health related quality of life (QoL) assessed by Functional Assessment of Cancer Therapy - Ovarian (FACT-O) questionnaire for each study group
In the context of this study the specific ovarian cancer symptom-oriented questionnaire Functional Assessment of Cancer Therapy - Ovarian (FACT-O) is included to assess the progression/recurrence of ovarian cancer on Quality of Life. The minimum value is 0, the maximum value including the specific Ovarian Cancer Subscale (OCS) is 152. The higher the score, the better the QOL
Measured: Up to approximately 5.25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start5 Nov 2020
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian Neoplasm EpithelialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss GO Trial Group
- Sponsor type
- Research network
- 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
- Responsible party
- Sponsor
- Investigators
- Heinzelmann-Schwarz, Prof. MD PhD, Principal investigator, University Hospital Basel, Head Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111978
- Sponsor's protocol ID
- ENGOT-ov54/Swiss-GO-2/MATAO
- Other IDs
- 2024-511219-78-00, 2019-002264-27, ENGOT-ov54, Swiss-GO-2, AGO-OVAR 26, AGO 65, 2019
- Acronym
- MATAO
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2019
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McLaughlin PMJ, Klar M, Zwimpfer TA, Dutilh G, Vetter M, Marth C, du Bois A, Schade-Brittinger C, Reuss A, Bommer C, Kurzeder C, Heinzelmann-Schwarz V. Maintenance Therapy with Aromatase Inhibitor in epithelial Ovarian Cancer (MATAO): study protocol of a randomized double-blinded placebo-controlled multi-center phase III Trial. BMC Cancer. 2022 May 6;22(1):508. doi: 10.1186/s12885-022-09555-8.
PubMed 35524184
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT04111978
- Acronym / sponsor ID
- MATAO / 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
- Keywords
- maintenance therapy, aromatase inhibitor, primary ovarian cancer, estrogen-receptor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Swiss GO Trial GroupResearch network
- 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
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Femara (letrozole) is an extensively investigated, marketed aromatase inhibitor (AI) widely used as treatment in the maintenance phase of estrogen-receptor (ER) positive breast cancer, as it inhibit the synthesis of estrogens. Estrogen is a well known driver of cancer growth in ER-positive tumors and a high percentage of the epithelial ovarian cancers express ER as well. Of which low grade ovarian cancers demonstrates the highest level of expression, supporting our strategy of a sub-group analysis (LOGOS). Therefore, letrozole in this study be investigated prospectively and evaluated as maintenance therapy after standard surgical and chemotherapy treatment in comparison to placebo (which is the current standard maintenance treatment) in subjects with primary, ER-positive low or high grade serous or endometrioid epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) of FIGO Stage II-IV, whose cancer has not progressed by the end of the platinum-based chemotherapy.
The objectives are to evaluate the letrozole maintenance treatment compared to placebo in terms of
- progression-free survival (PFS; primary endpoint)
- overall survival (OS)
- quality-adjusted progression free survival (QAPFS)
- time to first subsequent treatment (TFST)
- quality-adjusted time without symptoms of toxicity (Q-TWiST)
- health related quality of life (QoL) assessed by EQ-5D-5L, FACT-ES and FACT-O questionnaires
Methods: 540 for this study eligible subjects are 1:1 allocated in this randomized, controlled, double-blinded, multi-centre study to either the test (letrozole) or control (placebo) group. The maximum maintenance treatment duration is 5 years or until symptoms of toxicity or progression of underlying disease.
Health and health-related quality of life will continuously be assessed at study entry and during routine recalls which are scheduled every 12 weeks for the first 2 years, followed by every 24 weeks for the next 3 years. Procedures performed to assess the participants' health are the same as are performed during the regular routine ovarian cancer follow-up visits: blood tests, physical as well as gynaecological examinations and may include imaging. In addition, the participants are asked to complete during the study quality of life (QoL) specific questionnaires and wear an activity tracker for one week just before the scheduled visits. These assessments will be used for the evaluation of letrozole's efficacy and burden in comparison to the standard maintenance treatment. Survival follow-up data after the mainentance treatment duration of 5 years (study end) are obtained for up to another 7 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole (aromatase inhibitor) | Experimental | Drug: Letrozole 2.5mgLetrozole, 2.5 mg Femara tablet, administered once daily for 5 years or until symptoms of toxicity or progression of underlying disease |
| Placebo | Placebo comparator | Other: PlaceboPlacebo tablet of Femara (without aromatase inhibitor), 0 mg Femara tablet, administered once daily for 5 years or progression of underlying disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole 2.5mgAlso: FemaraAromatase inhibitor | Drug | Letrozole (aromatase inhibitor) |
| PlaceboPlacebo tablet of Femara | Other | Placebo |
Primary outcome
Progression-free survival (PFS) for each study group
Time frame: Up to approximately 12 years
PFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression. Assessment of progression (recurrence) is generally indicated by SYMPTOMS and will be assessed by the investigator most commonly on the basis of CT scans of the pelvis, abdomen and thorax, according to RECIST v1.1 criteria recommended and mostly presented by an elevated CA-125 level. Elevated CA-125 levels alone shouldn't be considered as progression. Progression assessment according to local standard of care, however, is similarly acceptable.
6 secondary outcomes
Overall survival (OS) for each study group
Time frame: Up to approximately 12 years
Quality-adjusted progression free survival (QAPFS) for each study group
Time frame: Up to approximately 12 years
Time to first subsequent treatment (TFST) for each study group
Time frame: Up to approximately 12 years
Quality-adjusted time without symptoms of toxicity (Q-TWiST) for each study group
Time frame: Up to approximately 12 years
Health related quality of life (QoL) assessed byFunctional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire for each study group
Time frame: Up to approximately 5.25 years
Health related quality of life (QoL) assessed by Functional Assessment of Cancer Therapy - Ovarian (FACT-O) questionnaire for each study group
Time frame: Up to approximately 5.25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Derived from this study: PubMed 35524184McLaughlin PMJ, Klar M, Zwimpfer TA, Dutilh G, Vetter M, Marth C, du Bois A, Schade-Brittinger C, Reuss A, Bommer C, Kurzeder C, Heinzelmann-Schwarz V. Maintenance Therapy with Aromatase Inhibitor in epithelial Ovarian Cancer (MATAO): study protocol of a randomized double-blinded placebo-controlled multi-center phase III Trial. BMC Cancer. 2022 May 6;22(1):508. doi: 10.1186/s12885-022-09555-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heinzelmann-Schwarz, Prof. MD PhD principal investigator
University Hospital Basel, Head Women's Hospital
53 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozole 2.5mg in people with Ovarian Neoplasm Epithelial and Fallopian Tube Neoplasms, run by Swiss GO Trial Group at 53 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Germany, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact McLaughlin, PhD (+41 61 328 42 04, mclaughlin@swiss-go.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) for each study group (time frame: Up to approximately 12 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04111978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.