Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

NCT00217399 | Completed Phase 1 Results

• 4 other identifiers: NCI-2009-00069CDR00004400672004-2516584
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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. Estradiol can cause the growth of breast cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estradiol by the tumor cells. Sometimes when hormone therapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to hormone therapy. Giving sorafenib together with anastrozole may reduce drug resistance and allow the tumor cells to be killed. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with anastrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.

Conditions

Recurrent Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Complete Response + Partial Response + Stable Disease > 24 Weeks

  Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking. A patient has clinical benefit from treatment if CR + PR + SD \> 24 weeks.

  24 weeks

Secondary Outcomes (2)

• Number of Participants With Adverse Events

  1 year

• Tumor Marker Analysis

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

PHASE I: Patients receive oral sorafenib twice daily and oral anastrozole once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD. PHASE II: Patients receive sorafenib at the MTD and anastrozole as in phase I.

Drug: sorafenib tosylate; Drug: anastrozole

Interventions

sorafenib tosylate DRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

Treatment

anastrozole DRUG

Given orally

Also known as: ANAS, Arimidex, ICI-D1033

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed breast cancer
• Metastatic disease
• Measurable disease, defined as \>=1 unidimensionally measurable lesion, including \>= 1 of the following:
• Lesion \>= 10 mm on CT scan (5 mm sections)
• Lesion \>= 20 mm on CT scan or MRI (10 mm sections)
• Bone disease that is \>= 10 mm on MRI
• Lytic bone lesions that are \>= 10 mm on CT scan (with 5 mm sections) OR \>= 20 mm on plain film or CT scan (with 10 mm sections)
• Lesion \>= 10 mm on physical exam
• Patients must have received \>= 1 prior aromatase inhibitor in either the adjuvant or metastatic setting and must have had either disease recurrence or disease progression on a prior aromatase inhibitor therapy
• No brain metastases diagnosed within the past 6 months OR previously untreated brain metastases
• Estrogen receptor-positive and/or progesterone receptor-positive, defined as \> 1% staining by immunohistochemistry or \> 10 fmol/mg of protein by radio-ligand dextran-coated steroid binding assay
• Postmenopausal, as defined by 1 of the following:
• Prior bilateral oophorectomy
• No menses for \>= 12 months in patients with an intact uterus
• Follicle-stimulating hormone (FSH) in postmenopausal range in patients \< 60 years of age who have had a prior hysterectomy or have been amenorrheic for \>= 3 months

You may not qualify if:

• estrogen receptor status unknown
• history of myocardial infarction within 6 months
• performance status 3
• performance status 4
• premenopausal
• progesterone receptor status unknown
• HIV positive

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sorafenib; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Nitriles; Triazoles; Azoles

Results Point of Contact

• Title: Dr. Claudine Isaacs
• Organization: Georgetown University

isaacsc@georgetown.edu

202-444-3677

Study Officials

• Claudine Isaacs

  Lombardi Comprehensive Cancer Center at Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2013
• Last Updated: May 28, 2014
• Results First Posted: February 12, 2013

Record last verified: 2012-12

Locations

US (1)