Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)

This is an Italian, multicenter, randomized, open-label phase III trial which will evaluate if Letrozole is superior to standard adjuvant chemotherapy in patients with hormone receptor positive low-grade serous epithelial carcinoma of the ovary (LGSCO). The hypothesis is that letrozole will significantly prolong median progression free survival (PFS) compared with the standard chemotherapy treatment, namely carboplatin AUC 5 and paclitaxel 175 mg/m2.

Trial Details

NCT ID
NCT05601700
Phase
PHASE3
Sponsor
Ente Ospedaliero Ospedali Galliera
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Letrozole tablets
  • carboplatin AUC 5 and paclitaxel 175 mg/m2
Locations (sample)
  • Arezzo, AR, Italy|43.46276,11.88068
  • Ponderano, BI, Italy|45.53846,8.05592
  • Belluno, BL, Italy|46.14262,12.2156
  • Brescia, BS, Italy|45.53558,10.21472
  • Brescia, BS, Italy|45.53558,10.21472

Key Eligibility Criteria

  • I - 1. Age ≥ 18 years. I - 2. Newly diagnosed, low-grade serous carcinoma of the ovary including cancer of fallopian tube and peritoneum (invasive …
  • I - 3. Immunohistochemically determined positivity (≥ 10%) for ER and/or PgR expression. This is to be confirmed by centralized review.
  • I - 4. Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status.
  • I - 5. Stage III-IV according to 2018 FIGO classification. For proper staging:

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Ovarian Cancer Trials on Trialify →