MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancer

Phase 1

Conditions: Patients with low and high grade serous and endometrioid ovarian cancer patients.
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2019-002264-27-DE

Lead Sponsor: Swiss GO Trial Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 540

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

•Progressive disease at the end of adjuvant treatment
•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 mal-absorption