Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Ductal Carcinoma in Situ or Stage I, Stage II, or Stage III Breast Cancer - Full Text View

Sponsor:	Sidney Kimmel Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00244959

Purpose

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.

PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: anastrozole Procedure: adjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

Drug Information available for: Anastrozole

U.S. FDA Resources

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

Primary Outcome Measures:

Change in breast density after 12 months of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in hormone levels after 12 months of treatment [ Designated as safety issue: No ]
Comparison between change in breast density with change in hormone levels after 12 months of treatment [ Designated as safety issue: No ]
Comparison between the frequency of aromatase polymorphisms with changes in breast density and hormone levels after 12 months of treatment [ Designated as safety issue: No ]
Comparison between change in bone density with change in hormone levels after 12 months of treatment [ Designated as safety issue: No ]
Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2004

Detailed Description:

OBJECTIVES:

Primary

Determine the 12-month change in breast density in postmenopausal women with ductal carcinoma in situ (DCIS) or stage I-III breast cancer treated with adjuvant anastrozole.

Secondary

Determine the change in estrone sulfate levels in patients treated with this drug.
Correlate the change in breast density with the change in circulating estrone sulfate levels in patients treated with this drug.
Determine the frequency of polymorphisms in aromatase (CYP19) and evaluate the relationship between wild-type aromatase enzyme with change in breast density and change in estrone sulfate levels in patients treated with this drug.
Determine the 12-month change in bone density, and correlate it with the change in circulating estrone sulfate levels in patients treated with this drug.
Correlate the reversal of hypermethylation with change in circulating estrone sulfate levels and breast density in patients treated with this drug.

OUTLINE: This is a pilot study. Patients are stratified according to concurrent bisphosphonate use (yes vs no).

Patients receive oral anastrozole once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer meeting 1 of the following criteria:
- Ductal carcinoma in situ (DCIS)
- Invasive carcinoma
  - Stage I-III disease
Must have undergone breast cancer surgery within the past 6 months, including any of the following:
- Mastectomy or lumpectomy with or without radiation
- Sentinel node and/or axillary node dissection
- Re-excision of lumpectomy margins
Intact contralateral breast
- No prior radiation therapy or mastectomy
- Prior biopsies allowed
Hormone receptor status:
- Estrogen and/or progesterone receptor-positive tumor by immunohistochemical staining

PATIENT CHARACTERISTICS:

Sex

Female

Menopausal status

Postmenopausal, defined as 1 of the following:
- At least 60 years of age
- Less than 60 years of age and amenorrheic ≥ 12 months prior to study entry
- Less than 60 years of age, amenorrheic for < 12 months prior to day 1, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range
- Less than 60 years of age, without a uterus, and LH and FSH values within postmenopausal range
- Underwent prior bilateral oophorectomy
- Underwent prior radiation castration AND amenorrheic for ≥ 6 months

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

PRIOR CONCURRENT THERAPY:

Chemotherapy

No prior or concurrent adjuvant chemotherapy for breast cancer

Endocrine therapy

No prior aromatase inhibitor
At least 6 weeks since prior and no concurrent tamoxifen
At least 6 weeks since prior and no concurrent hormone replacement therapy
- Concurrent low-dose, local vaginal estrogen in the form of either a conjugated estrogen ring or other similar product (e.g., Estring® or Vagifem®) allowed
At least 6 weeks since prior and no other concurrent selective estrogen receptor modulators (e.g., raloxifene)

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics
No contralateral breast implant

Other

Concurrent bisphosphonates allowed at the discretion of the treating oncologist
No concurrent consumption of soy supplements
- Concurrent routine dietary consumption of soy-containing foods allowed
No other concurrent investigational or commercial drugs or therapies for the treatment of DCIS or invasive breast cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244959

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Vered Stearns, MD

Sidney Kimmel Comprehensive Cancer Center

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

Study ID Numbers:	CDR0000446285, JHOC-J0365, JHOC-SKCCC-J0365, JHOC-IRB-03100706
Study First Received:	October 25, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00244959 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

stage IIIC breast cancer
ductal breast carcinoma in situ
breast cancer in situ

Additional relevant MeSH terms:

Anastrozole
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Immunologic Factors
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Breast Neoplasms
Enzyme Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Therapeutic Uses
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Aromatase Inhibitors
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010