Using letrozole as maintenance therapy for ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of adding letrozole, an aromatase inhibitor, to standard maintenance therapy for patients with estrogen-receptor positive high and low grade epithelial ovarian cancer after initial surgery and chemotherapy. Participants will be randomly assigned to receive either letrozole or a placebo to determine if letrozole improves progression-free survival compared to standard treatment. The study aims to assess various outcomes, including overall survival and quality of life, using validated questionnaires. A total of 540 eligible subjects will be enrolled in this Phase 3 trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Krankenhaus der Barmherzigen Brüder Graz
  Graz, Austria Recruiting
• Medizinische Universität Graz
  Graz, Austria Recruiting
• Medizinische Universität Innsbruck
  Innsbruck, Austria Recruiting
• Landeskrankenhaus Hochsteiermark Leoben
  Leoben, Austria Recruiting
• Ordensklinikum Linz Barmherzige Schwestern
  Linz, Austria Recruiting
• Universitätsklinikum Salzburg
  Salzburg, Austria Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Heinzelmann-Schwarz, Prof. MD PhD — University Hospital Basel, Head Women's Hospital
• Study coordinator: McLaughlin, PhD
• Email: mclaughlin@swiss-go.ch
• Phone: +41 61 328 42 04

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.