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

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).

Study Overview

• Status: Recruiting
• Conditions: Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasm Epithelial; High-grade Serous Ovarian Carcinoma (HGSOC); Low-grade Serous Ovarian Carcinoma (LGSOC); Ovarian Endometrioid Carcinoma
• Intervention / Treatment: Drug: Letrozole 2.5mg; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 540
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pamela McLaughlin, PhD; Phone Number: +41 61 328 42 04; Email: pamela.mclaughlin@usb.ch
• Study Contact Backup: Name: Maren Vogel, PhD; Phone Number: +41 61 3284203; Email: maren.vogel@usb.ch

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medizinische Universität Graz
    • Contact: Edgar Petru, Prof. Dr.; Phone Number: +43 316 385 81082; Email: Edgar.Petru@uniklinikum.kages.at
  • Graz, Austria, 8020
    • Recruiting
    • Krankenhaus der Barmherzigen Brüder Graz
    • Contact: Ursula Sevelda, Dr. med.; Phone Number: +43 316 7067 16657; Email: ursula.sevelda@bbgraz.at
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medizinische Universität Innsbruck
    • Contact: Christian Marth, Prof. Dr.; Phone Number: +4350/504 23051; Email: christian.marth@i-med.ac.at
  • Leoben, Austria, 8700
    • Not yet recruiting
    • Landeskrankenhaus Hochsteiermark Leoben
    • Contact: Cornelia Peternell, Dr med.; Email: Cornelia.Peternell@kages.at
    • Contact: Barbara Spreitzer; Phone Number: +43 3842401 2382; Email: Barbara.Spreitzer@kages.at
  • Linz, Austria, 4010
    • Recruiting
    • Ordensklinikum Linz Barmherzige Schwestern
    • Contact: Judith Lafleur, Dr. med.; Phone Number: +43 732 76777160; Email: Judith.lafleur@ordensklinikum.at
  • Salzburg, Austria, 5020
    • Not yet recruiting
    • Universitätsklinikum Salzburg
    • Contact: Gerhard Bogner, PD. Dr. med.; Phone Number: +43 5 7255 57964; Email: g.bogner@salk.at
  • Wien, Austria, 1090
    • Recruiting
    • Medizinische Universität Wien
    • Contact: Stephan Polterauer, Assoc. Prof. Priv. Doz. Dr.; Phone Number: +43140400 61091; Email: Stephan.polterauer@meduniwien.ac.at
  • Wien, Austria, 1130
    • Recruiting
    • Klinik Hietzing Wien
    • Contact: Ursula Denison, Dr. med.; Phone Number: +43 1 80 110 2294
    • Contact: Petra Hnizdo; Phone Number: +43 180110 2170; Email: kligynonko@hotmail.com
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité - Universitätsmedizin Berlin Campus Virchow Klinikum
    • Contact: Radoslav Chekerov, PD Dr med; Phone Number: +49 30 450 664 399; Email: radoslav.chekerov@charite.de
    • Contact: Klaus Pietzner, PD Dr med; Phone Number: +49 30 450 664 386; Email: klaus.pietzner@charite.de
  • Deggendorf, Germany, 94469
    • Recruiting
    • DONAUISAR Klinikum
    • Contact: Sara Tato-Varela, Dr. med.; Phone Number: +49 991 380 3158; Email: sara.tato-varela@donau-isar-klinikum.de
    • Contact: Walter Kuhn, Prof.Dr.med.; Phone Number: +49 991 380 3151; Email: walther.kuhn@donau-isar-klinikum.de
  • Düsseldorf, Germany, 40217
    • Recruiting
    • Evangelisches Krankenhaus Düsseldorf
    • Contact: Carolin Nestle-Krämling, Dr med; Phone Number: +49 211 919 483 542; Email: carolin.nestle-kraemling@evk-duesseldorf.de
    • Contact: Eleni Tsepelidou, Dr med; Phone Number: +49 211 919 1021; Email: eleni.tsepelidou@evk-duesseldorf.de
  • Essen, Germany, 45136
    • Recruiting
    • Evangelische Kliniken Essen Mitte GmbH
    • Contact: Julia Welz, Dr. med.; Phone Number: +49 201 17434531; Email: j.welz@kem-med.com
    • Contact: Philipp Harter, Prof Dr med.; Phone Number: +49 201 174-34021; Email: p.harter@kem-med.com
  • Esslingen, Germany, 73730
    • Recruiting
    • Klinikum Esslingen
    • Contact: Alexander Hein, PD Dr med; Phone Number: +49 711 3103 3051; Email: a.hein.cto@klinikum-esslingen.de
    • Contact: Bettina Braun, Dr med; Phone Number: +49 711 3103 3051; Email: b.braun@klinikum-esslingen.de
  • Freiburg, Germany, 79106
    • Recruiting
    • University Hospital Freiburg
    • Contact: Maximillian Klar, Prof Dr med; Phone Number: +49 761 270-31680; Email: Maxmaximilian.klar@uniklinik-freiburg.de
    • Contact: Florin-Andrei Taran, Prof Dr med; Phone Number: : +49 761 270-77112; Email: florin-andrei.taran@uniklinik-freiburg.de
  • Hildesheim, Germany, 31134
    • Recruiting
    • Gynäkologisch-Onkologische Gemeinschaftspraxis Dres. med. C.Uleer/J.Y.Pourfard
    • Contact: Christoph Uleer, Dr med; Phone Number: +49 512 1590 247; Email: c.uleer@gmx.de
    • Contact: Jasmin Pourfard, Dr med; Phone Number: +49 512 1590 247; Email: j.pourfard@gmx.de
  • Konstanz, Germany, 78464
    • Recruiting
    • Klinikum Konstanz
    • Contact: Andreas Zorr, Dr med; Phone Number: +49 7531 801 1601; Email: andreas.zorr@glkn.de
    • Contact: Kristina Bätge, MD; Phone Number: +49 7531 801 1616; Email: kristina.baetge@glkn.de
  • Köln, Germany, 50935
    • Recruiting
    • St. Elisabeth-Krankenhaus
    • Contact: Daniel Rein, Prof Dr med; Phone Number: +49 221 4677 1301; Email: daniel.rein@hohenlind.de
    • Contact: Christin Traut, MD; Phone Number: +49 221 4677 1312; Email: christin.traut@hohenlind.de
  • Münster, Germany, 48149
    • Recruiting
    • University Hospital Münster
    • Contact: Ralph Witteler, Dr med; Phone Number: +49 251 83 48236; Email: ralf.witteler@ukmuenster.de
    • Contact: Sebastian Schäfer, Dr med; Phone Number: +49 251 83 44107; Email: sebastiandaniel.schaefer@ukmuenster.de
  • Ravensburg, Germany, 88212
    • Recruiting
    • Studienzentrum Onkologie Ravensburg
    • Contact: Martina Gropp-Meier, Dr. med.; Phone Number: +497513661970; Email: matrina.gropp-meier@oberschwabenklinik.de
    • Contact: Thomas Decker, Prof Dr med.; Phone Number: +49 751 3661970; Email: thomas.decker@onkonet.eu
  • Schweinfurt, Germany, 97422
    • Recruiting
    • Leopoldina Krankenhaus der Stadt Schweinfurt
    • Contact: Michael Weigel, Prof; Phone Number: +4997217202132; Email: mweigel@leopoldina.de
    • Contact: Elke Wiegand, Dr. med.; Phone Number: +4997217202132; Email: ewiegand@leopoldina.de
  • Wiesbaden, Germany, 65199
    • Recruiting
    • Helios Dr. Horst Schmidt Kliniken Wiesbaden
    • Contact: Michael Eichbaum, Prof Dr med; Phone Number: +49 611 432 377; Email: michael.eichbaum@helios-gesundheit.de
    • Contact: Tatjana Cordes, Dr med; Phone Number: +49 611/433234; Email: tatjana.cordes@helios-gesundheit.de
  • Wolfsburg, Germany, 38440
    • Recruiting
    • AMO Wolfsburg / AMO MVZ GmbH
    • Contact: clemens Liebrich, Dr med; Phone Number: +49 536 180 3813; Email: clemens.liebrich@klinikum.wolfsburg.de
    • Contact: Vanessa Zahn, MD; Phone Number: +49 536 180 3813; Email: vanessa.zahn@klinikum.wolfsburg.de
• Switzerland
  • Baden, Switzerland, 5404
    • Recruiting
    • Kantonsspital Baden AG
    • Contact: Martin Heubner, Prof.; Phone Number: +41 (0)56 486 3502; Email: martin.heubner@ksb.ch
  • Basel, Switzerland, 4002
    • Recruiting
    • Basel Claraspital AG
    • Contact: Thomas Schmid, Dr. med.; Phone Number: +41 (0)61 685 88 65; Email: thomas.schmid@claraspital.ch
  • Bern, Switzerland, 3010
    • Recruiting
    • Universitätsklinik für Medizinische Onkologie, Inselspital
    • Contact: Julian Wampfler, Dr. med et phil; Phone Number: +41 (0)31 632 4636; Email: julian.wampfler@insel.ch
  • Bern, Switzerland, 3012
    • Recruiting
    • Praxis im Frauenzentrum Lindenhofspital
    • Contact: Ralf Rothmund, Prof.; Phone Number: +41 (0)31 300 85 80; Email: ralf.rothmund@lindenhofgruppe.ch
  • Chur, Switzerland, 7000
    • Recruiting
    • Kantonspital Graubünden (KSGR),
    • Contact: Michael Schwitter, Dr. med.; Phone Number: +41 (0)81 256 66 46; Email: Michael.Schwitter@ksgr.ch
  • Frauenfeld, Switzerland, 8501
    • Recruiting
    • Kantonsspital Frauenfeld
    • Contact: Mathias Fehr, Prof.; Phone Number: +41 (0)52 723 7255; Email: mathias.fehr@stgag.ch
  • Geneva, Switzerland, 1205
    • Recruiting
    • Hôpitaux Universitaires de Genève
    • Contact: Intidar Labidi-Galy, Dr. med.; Phone Number: +41 (0)22 372 4014; Email: intidhar.labidi-galy@hcuge.ch
  • Grabs, Switzerland, 9472
    • Recruiting
    • Frauenklinik Spital Grabs
    • Contact: Seraina Schmid, PD; Phone Number: +41 (0)81 772 5410; Email: seraina.schmid@srrws.ch
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Universitätsspital Waadt/ CHUV
    • Contact: Apostolos Sarivalasis, Dr. med.; Phone Number: +41 (0)79 556 73 62; Email: apostolos.sarivalasis@chuv.ch
  • Liestal, Switzerland, 4410
    • Recruiting
    • Kantonsspital Baselland
    • Contact: Marcus Vetter, Dr. med.; Phone Number: +41 61 925 2525; Email: marcus.vetter@ksbl.ch
  • Luzern, Switzerland, 6000
    • Recruiting
    • Luzerner Kantonsspital
    • Contact: Stefan Aebi, Prof.; Phone Number: +41 (0)41 205 5860; Email: stefan.aebi@luks.ch
  • Luzern, Switzerland, 6006
    • Recruiting
    • Tumorzentrum Hirslanden Klinik St. Anna
    • Contact: Andreas Günthert, Prof; Phone Number: +41 (0)41 208 41 13; Email: Andreas.guenthert@hin.ch
  • Münsterlingen, Switzerland, 8596
    • Recruiting
    • Kantonsspital Münsterlingen
    • Contact: Christian Taverna, Dr. med.; Phone Number: +41 (0)71 686 22 02; Email: christian.taverna@stgag.ch
  • Saint Gallen, Switzerland, 9007
    • Recruiting
    • Kantonsspital St. Gallen
    • Contact: René Hornung, Prof.; Phone Number: +41 (0)71 494 18 62; Email: Rene.Hornung@kssg.ch
  • Winterthur, Switzerland, 8401
    • Recruiting
    • Kantonsspital Winterthur
    • Contact: Andreas Müller, Dr. med.; Phone Number: +41 (0)52 266 3644; Email: andreas.mueller@ksw.ch
  • Zürich, Switzerland, 8063
    • Recruiting
    • Stadtspital Triemli
    • Contact: Natalie Gabriel, Dr. med.; Phone Number: +41 (0)44 416 20 04; Email: natalie.gabriel@triemli.zuerich.ch
  • Zürich, Switzerland, 8032
    • Recruiting
    • Klinik für Onkologie und Hämatologie Hirslanden Zürich AG
    • Contact: Anita Hirschi-Blickenstorfer, Dr. med.; Phone Number: +41 (0)44 387 3761; Email: anita.hirschi@kho.ch
  • Zürich, Switzerland, 8091
    • Recruiting
    • Unispital Zürich
    • Contact: Andreas Wicki, Porf.; Phone Number: +41 (0)44 255 91 16; Email: andreas.wicki@usz.ch
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4031
      • Recruiting
      • Universitätsspital Basel
      • Contact: Viola Heinzelmann-Schwarz, Prof; Phone Number: +41 (0)61 265 58 83; Email: viola.heinzelmann@usb.ch
  • Kanton Aargau
    • Aarau, Kanton Aargau, Switzerland, 5001
      • Recruiting
      • Kantonsspital Aarau AG
      • Contact: Dimitri Sarlos, PD; Phone Number: +41 (0)62 838 5065; Email: dimitri.sarlos@ksa.ch
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • Recruiting
      • Oncology Institute of Southern Switzerland (IOSI)-Ente Ospedaliero Cantonale (EOC)
      • Contact: Maria Del Grande, Dr med,; Phone Number: +41 (0)91 811 89 24; Email: maria.delgrande@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Letrozole (aromatase inhibitor); Letrozole, 2.5 mg Femara tablet, administered once daily for 5 years or until symptoms of toxicity or progression of underlying disease	Drug: Letrozole 2.5mg; Aromatase inhibitor; Other Names: Femara
Placebo Comparator: Placebo; Placebo tablet of Femara (without aromatase inhibitor), 0 mg Femara tablet, administered once daily for 5 years or progression of underlying disease	Other: Placebo; Placebo tablet of Femara

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 12 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	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	Up to approximately 5.25 years

Collaborators and Investigators

• Sponsor: Swiss GO Trial Group
• Collaborators: Hoffmann-La Roche; Novartis Pharmaceuticals; AGO Study Group; Anticancer Fund, Belgium; Arbeitsgemeinschaft Gynaekologische Onkologie Austria; Reliable Cancer Therapies; Krebsliga Schweiz; Stiftung Guido Feger; Helsana AG
• Investigators: Principal Investigator: Viola Heinzelmann-Schwarz, Prof. MD PhD, University Hospital Basel, Head Women's Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: aromatase inhibitor; maintenance therapy; primary ovarian cancer; estrogen-receptor
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Abdominal Neoplasms; Endometrial Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Neoplasms; Carcinoma; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma, Endometrioid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: ENGOT-ov54/Swiss-GO-2/MATAO; 2019-002264-27 (EudraCT Number); ENGOT-ov54 (Other Identifier: European Network for Gynaecological Oncological Trial Groups); Swiss-GO-2 (Other Identifier: Swiss Network for Gynaecological Oncological Studies)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No