Status:
RECRUITING
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
Lead Sponsor:
Swiss GO Trial Group
Collaborating Sponsors:
AGO Study Group
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
Conditions:
Ovarian Neoplasm Epithelial
Fallopian Tube Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Femara (letrozole) is an extensively investigated, marketed aromatase inhibitor (AI) widely used as treatment in the maintenance phase of estrogen-receptor (ER) positive breast cancer, as it inhibit t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2032
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT04111978
Start Date
November 5 2020
End Date
July 1 2032
Last Update
September 29 2025
Active Locations (53)
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1
Krankenhaus der Barmherzigen Brüder Graz
Graz, Austria, 8020
2
Medizinische Universität Graz
Graz, Austria, 8036
3
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
4
Landeskrankenhaus Hochsteiermark Leoben
Leoben, Austria, 8700