NCT04111978 MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
| NCT ID | NCT04111978 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Swiss GO Trial Group |
| Condition | Ovarian Neoplasm Epithelial |
| Study Type | INTERVENTIONAL |
| Enrollment | 540 participants |
| Start Date | 2020-11-05 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 540 participants in total. It began in 2020-11-05 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Heinzelmann-Schwarz, Prof. MD PhD
PRINCIPAL INVESTIGATOR
University Hospital Basel, Head Women's Hospital
Frequently Asked Questions
Who can join the NCT04111978 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Neoplasm Epithelial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04111978 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 540 participants.
Is NCT04111978 currently recruiting?
Yes, NCT04111978 is actively recruiting participants. Contact the research team at mclaughlin@swiss-go.ch for enrollment information.
Where is the NCT04111978 trial being conducted?
This trial is being conducted at Graz, Austria, Graz, Austria, Innsbruck, Austria, Leoben, Austria and 11 additional locations.
Who is sponsoring the NCT04111978 clinical trial?
NCT04111978 is sponsored by Swiss GO Trial Group. The principal investigator is Heinzelmann-Schwarz, Prof. MD PhD at University Hospital Basel, Head Women's Hospital. The trial plans to enroll 540 participants.