A Study of Letrozole in the Treatment of Endometrial Cancer

Novartis Pharmaceuticals36 enrolled

Overview

Currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. This study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent and Metastatic Endometrial Cancer

Interventions

LetrozoleDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria * Postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium * No adjuvant therapy * Up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed * No chemotherapy for recurrence (adjuvant permitted) * Unidimensionally measurable disease * Good Health status 0-2 (Eastern Cooperatitve Oncology Group) * No prior tamoxifen or aromatase inhibitor therapy * No other concurrent anti-cancer treatment * No metastases in the central nervous system Exclusion criteria: Additional protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Investigative Site

Heidelberg, Germany

Outcomes

Primary Outcomes

Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks

Secondary Outcomes

Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels

Data from ClinicalTrials.gov

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