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

This study has been completed.
Sponsor:
Collaborator:
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

October 25, 2005
March 18, 2013
January 2004
September 2007   (final data collection date for primary outcome measure)
Change in breast density after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00244959 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer
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.

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.

Interventional
Phase 2
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: anastrozole
    1 mg orally daily for 12 months
    Other Name: Arimidex
  • Procedure: adjuvant therapy
    treatment received after breast cancer surgery
Experimental: Anastrozole
Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer
Interventions:
  • Drug: anastrozole
  • Procedure: adjuvant therapy
Prowell TM, Blackford AL, Byrne C, Khouri NF, Dowsett M, Folkerd E, Tarpinian KS, Powers PP, Wright LA, Donehower MG, Jeter SC, Armstrong DK, Emens LA, Fetting JH, Wolff AC, Garrett-Mayer E, Skaar TC, Davidson NE, Stearns V. Changes in breast density and circulating estrogens in postmenopausal women receiving adjuvant anastrozole. Cancer Prev Res (Phila). 2011 Dec;4(12):1993-2001. doi: 10.1158/1940-6207.CAPR-11-0154. Epub 2011 Sep 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
November 2011
September 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00244959
J0365 CDR0000446285, P30CA006973, JHOC-J0365, JHOC-SKCCC-J0365
No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP