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).

Eligibility

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

Conditions7

Interventions1

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