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

March 18, 2013 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Arimidex
Procedure: adjuvant therapy
treatment received after breast cancer surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in breast density after 12 months of treatment
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in hormone levels after 12 months of treatment
Time Frame: 12 months
12 months
Comparison between change in breast density with change in hormone levels after 12 months of treatment
Time Frame: 12 months
12 months
Comparison between the frequency of aromatase polymorphisms with changes in breast density and hormone levels after 12 months of treatment
Time Frame: 12 months
12 months
Comparison between change in bone density with change in hormone levels after 12 months of treatment
Time Frame: 12 months
12 months
Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Vered Stearns, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria

October 25, 2005

First Posted (Estimate)

October 27, 2005

Study Record Updates

Last Update Posted (Estimate)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J0365 CDR0000446285
  • P30CA006973 (U.S. NIH Grant/Contract)
  • JHOC-J0365 (Other Identifier: SKCCC at Johns Hopkins)
  • JHOC-SKCCC-J0365 (Other Identifier: SKCCC at Johns Hopkins)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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