Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer - Full Text View

Purpose

The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: sorafenib	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

Further study details as provided by University of Kentucky:

Primary Outcome Measures:

Response rate [ Time Frame: 12 weeks after treatment & 8 weeks after initial documentation of response ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression [ Time Frame: continuously ] [ Designated as safety issue: No ]
Clinical benefit rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
Correlation between biomarkers and treatment outcome [ Time Frame: assessed after treatment response determined ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sorafenib & Endocrine Therapy	Drug: sorafenib 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All subjects must be female.
Age ≥ 18 years old.
Histologically proven carcinoma of the breast.
Estrogen receptor and/or Progesterone positive disease.
Metastatic or locally advanced disease.
Patients on a preexisting endocrine agent for at least 3 months before enrollment.
Have residual measurable disease after
1. maximal response to endocrine therapy or
2. no response to endocrine therapy or
3. progressive non-visceral disease on endocrine therapy.
Must be able to provide a tumor block from either the primary or metastatic site, if available.
ECOG Performance Status 0-2.
Adequate organ function.

Exclusion Criteria:

Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy.
Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ.
Prior use of anti-angiogenic agents.
As judged by the investigator, uncontrolled intercurrent illness.
Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
Known or suspected allergy to sorafenib or any agent given in the course of this trial.
A serious non-healing wound or ulcer.
Evidence or history of bleeding diathesis or coagulopathy.
Major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug.
Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within the 4 weeks prior to the first dose of study drug.
Pregnancy
Any condition that impairs patient's ability to swallow whole pills.
Documented malabsorption problem.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525161

Contacts


Contact: Vera Kadamyan-Melkumyan	859-257-3379	vgkada0@email.uky.edu

Contact: Suleiman A Massarweh, M.D.	859-323-6562	Massarweh@uky.edu

Locations


United States, Kentucky
	University of Kentucky	Recruiting
	Lexington, Kentucky, United States, 40536
	Contact: Vera Kadamyan 859-257-3379 vgkada0@email.uky.edu
	Contact: Suleiman A Massarweh, M.D. 859-323-6562 Massarweh@uky.edu

Sponsors and Collaborators

University of Kentucky

Bayer

Investigators


Principal Investigator:	Suleiman Massarweh, MD	University of Kentucky

More Information

Responsible Party:	University of Kentucky ( Suleiman A Massarweh, M.D. )
Study ID Numbers:	07-BRE-41-BP
First Received:	September 3, 2007
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00525161
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kentucky:

breast cancer

Sorafenib

Nexavar

Endocrine Therapy

Study placed in the following topic categories:

Skin Diseases

Breast Neoplasms

Sorafenib

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	University of Kentucky Bayer
Information provided by:	University of Kentucky
ClinicalTrials.gov Identifier:	NCT00525161