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

Launched by SWISS GO TRIAL GROUP · Sep 30, 2019

Keywords

ClinConnect Summary

The MATAO clinical trial is studying whether adding a medication called letrozole to standard maintenance treatment can help women with certain types of ovarian cancer live longer without their disease getting worse. This trial focuses on women who have recently been diagnosed with estrogen-receptor positive high or low grade epithelial ovarian cancer, including cancers of the fallopian tubes and peritoneum, after they have completed surgery and chemotherapy. Participants will be divided into two groups: one will receive letrozole along with standard treatment, while the other group will receive a placebo, which looks like the medication but has no active ingredients.

To be eligible for this trial, women must be at least 18 years old, have a confirmed diagnosis of specific types of ovarian cancer, and have completed at least four cycles of chemotherapy. They should also be willing to attend regular appointments and provide consent to participate. Throughout the trial, participants can expect to have regular check-ups to monitor their health and the effects of the treatment. This study aims to determine if letrozole can improve the time before cancer worsens, which is an important aspect of managing their condition.

Gender

FEMALE

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