Exemestane in Treating Postmenopausal Women at High Risk for Invasive Breast Cancer - Full Text View

Sponsor:	Lombardi Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00085072

Purpose

RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Exemestane may decrease estrogen levels and reduce breast density.

PURPOSE: This phase II trial is studying how well exemestane works in preventing cancer in postmenopausal women who are at high risk of developing invasive breast cancer.

Condition	Intervention	Phase
Breast Cancer Precancerous/Nonmalignant Condition	Drug: exemestane	Phase II

Study Type:	Interventional
Study Design:	Prevention, Open Label
Official Title:	A Trial Of Exemestane Alone Or In Combination With Celecoxib In Postmenopausal Women With DCIS Or At High Risk For Invasive Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Exemestane

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Effect of exemestane on mammographic density at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of this drug on bone mineral density [ Designated as safety issue: No ]
Effect of this drug on breast density at 2 years [ Designated as safety issue: No ]
Effect of this drug on serum hormones, insulin-like growth factor pathway components, and leptin at 3 months and 1 year [ Designated as safety issue: No ]
Effect of this drug on serum lipids, C-reactive protein, and homocysteine [ Designated as safety issue: No ]
Effect of this drug on breast tissue trefoil factor 1 and proliferating cell nuclear antigen expression, prolactin, and breast tissue prolactin receptor at 1 year [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	December 2004
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the effect of exemestane on mammographic density at 1 year in postmenopausal women at high risk for invasive breast cancer.

Secondary

Determine the effect of this drug on bone mineral density in these patients.
Determine the effect of this drug on breast density at 2 years in these patients.
Determine the effect of this drug on serum hormones (prolactin, estradiol, progesterone, dehydroepiandrosterone [DHEA], androstenedione, testosterone, and sex hormone-binding globulin), insulin-like growth factor (IGF) pathway components (IGF-I, IGF-II, IGF-binding protein [IGFBP]-2, IGFBP-3, and IGFBP-5), and leptin at 3 months and 1 year in these patients.
Determine the effect of this drug on serum lipids (total cholesterol, high-density lipoprotein, low-density lipoprotein, apolipoprotein a, apolipoprotein b, triglycerides), C-reactive protein, and homocysteine in these patients.
Determine the effect of this drug on breast tissue trefoil factor 1 and proliferating cell nuclear antigen expression, prolactin, and breast tissue prolactin receptor at 1 year in these patients.

OUTLINE: This is an open-label study.

Patients receive oral exemestane once daily for 2 years in the absence of the development of invasive breast cancer or unacceptable toxicity.

Quality of life is assessed at baseline and then at 12 and 24 months.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Determined to be at high risk for developing invasive breast cancer by meeting at least 1 of the following criteria:
- Gail Model risk of ≥ 1.7% for the next 5 years
- Lobular neoplasia
- Atypical ductal hyperplasia
- Ductal carcinoma in situ previously treated with mastectomy or lumpectomy and radiotherapy with or without tamoxifen
- Deleterious mutations in BRCA1 or 2
- A prior risk assessment of ≥ 20% chance of carrying BRCA1 or 2 gene mutation
- History of stage I or II invasive breast cancer that was definitively treated ≥ 2 years ago
Bone mineral density T-score ≥ -2.5 at anterior-posterior spine by baseline dual energy x-ray absorptiometry scan
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

Postmenopausal

Sex

Female

Menopausal status

Postmenopausal, defined as 1 of the following:
- FSH > 35 U/L
- No menses for at least 12 months
- Prior bilateral oophorectomy

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Hemoglobin ≥ 11 g/dL
No history of clotting or bleeding disorder

Hepatic

ALT and AST < 2.5 times upper limit of normal (ULN)

Renal

Creatinine < 1.5 times ULN

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Gastrointestinal

No active GI disease (e.g., inflammatory bowel disease)

Other

No history of allergic reactions attributed to compounds of similar chemical or biological composition to exemestane (e.g., anastrozole, letrozole, or formestane)
No concurrent uncontrolled illness
No active or ongoing infection
No psychiatric illness or social situation that would preclude study compliance
No other cancer except squamous cell or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Endocrine therapy

See Disease Characteristics
More than 3 months since prior and no concurrent hormonal therapy (e.g., oral contraceptives, hormone replacement therapy, tamoxifen, raloxifene, intrauterine device [IUD] with progestins, or corticosteroids)
- Chronic topical or inhaled steroids allowed
- Vaginal estrogen allowed
No prior aromatase inhibitors

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics

Other

More than 2 years since prior anticancer treatment
At least 30 days since prior investigational agents
No concurrent use of any of the following drugs:
- Phenytoin
- Carbamazepine
- Rifampin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085072

Locations

United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381

Sponsors and Collaborators

Lombardi Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Jennifer Eng-Wong, MD	Lombardi Cancer Research Center
Principal Investigator:	Suparna B. Wedam, MD	National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center ( Jennifer Eng-Wong )
Study ID Numbers:	CDR0000367245, GUMC-2007-313, NCI-04-C-0044, GUMC-2007-313
Study First Received:	June 10, 2004
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00085072 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer
ductal breast carcinoma in situ
lobular breast carcinoma in situ
atypical ductal breast hyperplasia

Additional relevant MeSH terms:

Precancerous Conditions
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Enzyme Inhibitors
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Exemestane
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009