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New treatment option for Ovarian Neoplasm Epithelial
Official title MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
ClinicalTrials.gov ID: NCT04111978
What this study is testing
What is Letrozole 2.5mg?
Letrozole 2.5mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian neoplasm epithelial.
Also referred to as Femara.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- (Interval-) debulking performed ECOG-Performance Status 0-2
- Signed informed consents (ICF-1; ICF-2)
You likely can't join if
- 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...
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Innsbruck, Austria
- Leoben, Austria
- Linz, Austria
- Salzburg, Austria
- Vienna, Austria
- Berlin, Germany
- Cologne, Germany
- Deggendorf, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Essen, Germany
- Esslingen am Neckar, Germany
- Freiburg im Breisgau, Germany
- Hamburg, Germany
- Hildesheim, Germany
- Konstanz, Germany
- Mainz, Germany
- Mannheim, Germany
- Münster, Germany
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Innsbruck, Austria; Leoben, Austria; Linz, Austria; Salzburg, Austria; Vienna, Austria and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.