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Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00244959
First received: October 25, 2005
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

Drug Information available for: Anastrozole
U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Change in breast density after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in hormone levels after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Comparison between change in breast density with change in hormone levels after 12 months of treatment [ Time Frame: 12 months ] [ 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Comparison between change in bone density with change in hormone levels after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: January 2004
Study Completion Date: November 2011
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anastrozole
Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer
 Drug: anastrozole
1 mg orally daily for 12 months
Other Name: Arimidex
Procedure: adjuvant therapy
treatment received after breast cancer surgery

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

Ages Eligible for Study:   18 Years and older
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

Publications:

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00244959     History of Changes
Other Study ID Numbers: J0365 CDR0000446285, P30CA006973, JHOC-J0365, JHOC-SKCCC-J0365
Study First Received: October 25, 2005
Last Updated: March 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Anastrozole
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013