NCT00634634

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

August 11, 2008

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
8 days until next milestone

Results Posted

Study results publicly available

May 6, 2023

Completed
Last Updated

November 9, 2023

Status Verified

October 1, 2023

Enrollment Period

10.7 years

First QC Date

March 5, 2008

Results QC Date

October 8, 2022

Last Update Submit

October 17, 2023

Conditions

Metastatic Breast Cancer

Keywords

breast cancerPostmenopausal Women with Hormone Receptor-Positive Locally Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

    The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.

    twenty eight days

Secondary Outcomes (3)

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

    6 months

  • Median Progressive-Free Survival (PFS)

    Approximately 4.6 years

  • Overall Survival (OS) Assessed as Mean Months

    Approximately 4.6 years

Study Arms (1)

Sorafenib and Letrozole

EXPERIMENTAL
Drug: SorafenibDrug: Letrozole

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.

Also known as: Nexavar
Sorafenib and Letrozole
LetrozoleDRUG

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

Also known as: Femara
Sorafenib and Letrozole

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed invasive breast cancer
  • Stage IIIB, IIIC with T4 lesion or Stage IV disease
  • Breast cancer must be ER-positive and/or PR-positive
  • Age ³ 18 years of age
  • ECOG performance status 0, 1 or 2
  • Able to swallow and oral medication
  • Adequate end organ function
  • Written informed consent

You may not qualify if:

  • Prior hormonal therapy for metastatic disease
  • Prior chemotherapy for metastatic disease
  • Prior treatment with sorafenib
  • Brain metastases or leptomeningeal disease
  • Evidence or history of bleeding
  • Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Cooper Hospital/University Medical Center

Voorhees Township, New Jersey, 08690, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

SorafenibLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingNitrilesTriazolesAzoles

Results Point of Contact

Title
Dr. Deborah Toppmeyer
Organization
Cancer Institute of New Jersey
toppmede@cinj.rutgers.edu
732-235-5203

Study Officials

  • Antoinette Tan, MD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Chief Medical Officer

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 13, 2008

Study Start

August 11, 2008

Primary Completion

April 20, 2019

Study Completion

April 28, 2023

Last Updated

November 9, 2023

Results First Posted

May 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)