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

Condition(s) studied

Investigational drug(s) / intervention(s)

Letrozole 2.5mg: Aromatase inhibitor

Placebo: Placebo tablet of Femara

Study 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).

Eligibility

Primary outcome measure(s)

• Progression-free survival (PFS) for each study group — 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.

Trial sites (53)

+ 13 more sites — see the full list on the official registry below.

Other trials for the same condition