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Open Access 01-12-2022 | Ovarian Cancer | Study protocol

Maintenance Therapy with Aromatase Inhibitor in epithelial Ovarian Cancer (MATAO): study protocol of a randomized double-blinded placebo-controlled multi-center phase III Trial

Authors: Pamela M. J. McLaughlin, Maximilian Klar, Tibor A. Zwimpfer, Gilles Dutilh, Marcus Vetter, Christian Marth, Andreas du Bois, Carmen Schade-Brittinger, Alexander Reuss, Claudine Bommer, Christian Kurzeder, Viola Heinzelmann-Schwarz

Published in: BMC Cancer | Issue 1/2022

Abstract

Background

A high percentage of epithelial ovarian cancers (EOC) express the estrogen receptor (ER), which is an ideal target for endocrine therapy. Letrozole is a proven, potent aromatase inhibitor, extensively tested and used in the treatment of ER positive breast cancer. In addition, it seems a potent drug for patients with heavily pre-treated OC as demonstrated in several distinctive settings. However, it has never been evaluated prospectively in a maintenance setting for ovarian cancer after standard of care. The here proposed trial aims to define a population of EOC patients, who would benefit from the effectiveness of the generic agent letrozole, with little expected toxicity and thus beneficial impact on overall quality of life (QoL).

Methods

In this international multicenter randomized, placebo-controlled phase III trial at clinical centers in Switzerland, Germany and Austria, we plan to include 540 patients with primary, newly diagnosed FIGO Stage II to IV and histologically confirmed low- or high-grade serous or endometrioid epithelial ovarian/fallopian tube/peritoneal cancer. Patients are randomized in a 1:1 ratio into two groups: receiving blinded study treatment (letrozole or placebo tablets). When assuming a HR of 0.7, a median PFS of 18 months in the control arm and a median PFS of 25.7 months in the treatment arm, a two-sided alpha level of 5%, 3.5 years recruitment and 1.5 years observation time, we expect 330 events to have occurred within these 5 years in the total cohort yielding a power of 90%. Follow-up data for the whole cohort will be collected for up to 10 years and for the low-grade cancer for up to 12 years.

Discussion

The here proposed randomized phase III trial aims to identify patients with EOC in the maintenance setting, who benefit from the effectiveness of the letrozole, by proving its efficacy whilst maintaining a high standard of QoL due to the limited toxicity expected in comparison to the current alternative drugs on the market for this treatment phase.

Trial registration

This trial is registered at clinicaltrials.gov under the identifier NCT04111978. Registered 02 October 2019.

Available only for authorised users

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Title: Maintenance Therapy with Aromatase Inhibitor in epithelial Ovarian Cancer (MATAO): study protocol of a randomized double-blinded placebo-controlled multi-center phase III Trial
Authors: Pamela M. J. McLaughlin
Maximilian Klar
Tibor A. Zwimpfer
Gilles Dutilh
Marcus Vetter
Christian Marth
Andreas du Bois
Carmen Schade-Brittinger
Alexander Reuss
Claudine Bommer
Christian Kurzeder
Viola Heinzelmann-Schwarz
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Ovarian Cancer
Ovarian Cancer
Maintenance Therapy
Letrozole
Published in: BMC Cancer / Issue 1/2022
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-022-09555-8

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