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

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 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).

Conditions

• Ovarian Neoplasm Epithelial
• Fallopian Tube Neoplasms
• Peritoneal Neoplasms
• High-grade Serous Ovarian Carcinoma (HGSOC)
• Low-grade Serous Ovarian Carcinoma (LGSOC)
• Ovarian Endometrioid Carcinoma

Interventions

DRUG

Letrozole 2.5mg

Aromatase inhibitor

OTHER

Placebo

Placebo tablet of Femara

Sponsors & Collaborators

• AGO Study Group

  collaborator OTHER

• Arbeitsgemeinschaft Gynaekologische Onkologie Austria

  collaborator OTHER

• Reliable Cancer Therapies

  collaborator INDUSTRY

• Krebsliga Schweiz

  collaborator UNKNOWN

• Stiftung Guido Feger

  collaborator UNKNOWN

• Hoffmann-La Roche

  collaborator INDUSTRY

• Helsana AG

  collaborator UNKNOWN

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• Anticancer Fund, Belgium

  collaborator OTHER

• Swiss GO Trial Group

  lead NETWORK

Principal Investigators

• Heinzelmann-Schwarz, Prof. MD PhD · University Hospital Basel, Head Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-05

Primary Completion

2027-07-01

Completion

2032-07-01

Countries

• Austria
• Germany
• Switzerland

Study Locations