A Phase 2 Trial of Letrozole and Everolimus in Relapsed Hormone Receptor Positive Ovarian, Fallopian Tube or Primary Peritoneal Carcinomas

Trial ID # NCT02283658
Phase II
Drug Class Hormonal Therapy: Aromatase
Drug Name Letrozole
Alternate Drug Names Femara
Drugs in Trial Everolimus, Letrozole
Eligible Participant

Estrogen-Receptor (ER)+ recurrent ovarian cancer

Patients Enrolled

19

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

PFS, OS, evaluated per RECIST

Biomarkers

ER protein

Efficacy

PFS: 3.9 months
OS: 13.0 months

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: any (63%), abdominal pain (16%), small intestinal obstruction (16%), anemia (16%), oral mucositis (11%), neutropenia (11%), lymphopenia (11%)

Conclusion

Promising results in ER-positive ovarian cancer

Reference

Colon-Otero G et al. Phase 2 trial of everolimus and letrozole in relapsed estrogen receptor-positive high-grade ovarian cancers. Gynecol Oncol (2017) 146(1):64-68
https://www.ncbi.nlm.nih.gov/pubmed/28461031

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