BridgeMD
MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancer
EU CTIS ID: 2024-511219-78-00
What this study is testing
To evaluate the efficacy of letrozole maintenance therapy after standard surgical and chemotherapy treatment as measured by Progression Free Survival (PFS) compared to no maintenance therapy (placebo)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must be ≥ 18 years of age
- 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.
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Patients must be ≥ 18 years of age
- 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.
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. 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 EU CTIS; the study team decides eligibility.