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

NCT04111978RecruitingPHASE3INTERVENTIONAL

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).

Key Facts

Lead Sponsor

Swiss GO Trial Group

Enrollment

540

Start Date

2020-11-05

Completion Date

2027-07-01

Study Type

INTERVENTIONAL

Official Title

MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer: a Randomized Double-blinded Placebo-controlled Multi-centre Phase III Trial (ENGOT-ov54/Swiss-GO-2/MATAO), Including LOGOS (Low Grade Ovarian Cancer Sub-study).

Interventions

Letrozole 2.5mgPlacebo

Conditions

Ovarian Neoplasm EpithelialFallopian Tube NeoplasmsPeritoneal NeoplasmsHigh-grade Serous Ovarian Carcinoma (HGSOC)Low-grade Serous Ovarian Carcinoma (LGSOC)Ovarian Endometrioid Carcinoma

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Progression-free survival (PFS) for each study group

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.