MATAO: MAintenance Therapie/ Erhaltungstherapie mit Aromatasehemmer für Patientinnen mit epithelialem Ovarialkarzinom: eine randomisierte doppelblinde Placebo-kontrollierte multizentrische Phase III Studie. (ENGOT-ov54/Swiss-GO-2/MATAO)

Drug: Letrozole 2.5mg;Other: Placebo

Gender: Female
Maximum age: N/A
Minimum age: 18 Years

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