At a glance
ClinicalIndex Comparison Record- ✓Age at least 18 years
- ✓Newly diagnosed low-grade serous carcinoma of ovary, fallopian tube, or peritoneum (micropapillary or grade 1), confirmed by central p53 IHC
- ✓ER and/or PgR positivity (≥10%) by centralized IHC review
- ✓Upfront surgery with maximal cytoreductive effort and optimal or suboptimal residual disease
- ✕Other malignancy within last 5 years (except adequately treated non-melanoma skin cancer)
- ✕Prior neoadjuvant chemotherapy or radiotherapy for this disease
- ✕Prior hormonal therapy for this disease
- ✕Known hypersensitivity to letrozole or hypersensitivity/intolerance to carboplatin/paclitaxel
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer: a Randomized Phase III Trial (LEPRE Trial)
In Brief
A Phase 3 clinical trial evaluating Letrozole tablets and carboplatin AUC 5 and paclitaxel 175 mg/m2 for Carcinoma, Ovarian Epithelial and Low Grade Serous Adenocarcinoma of Ovary. Currently recruiting, targeting 132 participants across 19 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
ATC: L02BG04
ATC: L01XA02 and ATC: L01CD01 respectively