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Aromatase Inhibitor

Letrozole + Sorafenib for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Antoinette Tan, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4.6 years

Awards & highlights

Study Summary

This trial studies the effects of combining letrozole and sorafenib to treat postmenopausal women with metastatic breast cancer. It looks at side effects and the best dose.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4.6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4.6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4.6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)

Secondary outcome measures

Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib

Median Progressive-Free Survival (PFS)

Overall Survival (OS) Assessed as Mean Months

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sorafenib and LetrozoleExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sorafenib

FDA approved

Letrozole

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,180 Total Patients Enrolled

16 Trials studying Breast Cancer

1,910 Patients Enrolled for Breast Cancer

Rutgers Cancer Institute of New JerseyOTHER

70 Previous Clinical Trials

18,705 Total Patients Enrolled

8 Trials studying Breast Cancer

1,923 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,101 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00634634 — Phase 1 & 2

Breast Cancer Research Study Groups: Sorafenib and Letrozole

Breast Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT00634634 — Phase 1 & 2

Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00634634 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what clinical circumstances are Sorafenib and Letrozole typically prescribed?

"Hemangiosarcoma, tamoxifen, and progressive cases of refractory differentiated thyroid carcinoma (dtc) can be managed with Sorafenib and Letrozole."

Answered by AI

How many participants are involved in this clinical trial?

"This clinical trial has ceased its recruiting efforts. It was first posted on August 11th 2008 and last edited on May 3rd 2023. Fortunately, there are 2357 active trials for breast cancer patients and 205 studies that investigate the use of Sorafenib or Letrozole to consider instead."

Answered by AI

Is acceptance for the clinical trial still being offered to individuals?

"At the moment, this research is not accepting participants. It was initially listed on August 11th 2008 and last updated May 3rd 2023. If you are searching for other experiments to be a part of, there are 2357 clinical trials related to breast cancer that require enrolment as well as 205 studies involving Sorafenib and Letrozole that have open positions available now."

Answered by AI

How prolific is the trial's presence in Canada?

"There are four medical sites actively accepting patients for this trial. These locations span from Voorhees to Atlanta, and Washington to other cities. To reduce the burden of travel it is advised that you select a clinic close by if you choose to participate."

Answered by AI

Are there any other scientific investigations into the efficacy of Sorafenib and Letrozole?

"The first studies of the efficacy of Sorafenib and Letrozole began at National Institutes of Health Clinical Center in 1995. Since then, 598 trials have been concluded while 205 are still ongoing; many of these being hosted in Voorhees, Georgia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer

Deborah Toppmeyer, MD 2008. "Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00634634.