CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Sorafenib +1 moredrug
Likely dose
Letrozole 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00634634
NCT00634634Phase 2Completed
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Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women With Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer

Rutgers, The State University of New Jersey·interventional·Posted Mar 13, 2008·Updated Nov 9, 2023

In Brief

A Phase 2 clinical trial evaluating Sorafenib and Letrozole for Metastatic Breast Cancer. Completed, enrolled 52 participants across 4 sites.

Detailed Summary

Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
CollaboratorsRutgers Cancer Institute of New Jersey, National Cancer Institute (NCI), Bayer, Novartis Pharmaceuticals

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2008
Enrollment StartAug 11, 2008
Primary CompletionApr 20, 2019
Study CompletionApr 28, 2023
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 18.3 years ago

Interventions

Sorafenibdrug

sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.

Letrozoledrug

Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28