Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Breast Density, Hormone Levels, and Anticancer Drug Levels in Women With Invasive Breast Cancer Who Are Receiving Exemestane or Anastrozole

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Biomarker/Laboratory analysis, Diagnostic Closed Postmenopausal NCI NCCTG-N0434 CAN-NCIC-MA27D, N0434 (MA.27D), NCT00316836, MA27D

Special Category: CTSU trial

Objectives

Primary

1. Assess the change in percent breast density and dense area in response to aromatase inhibitor therapy from pretreatment to 1 year, 1 year to 2 years, and pretreatment to 2 years in women with invasive breast cancer.
2. Determine the changes in percent breast density and dense area in response to aromatase inhibitor therapy from pretreatment to 1 year and correlate the changes with changes in plasma hormones (e.g., estrone, estrone-sulfate, estradiol, and sex hormone binding globulin) and drug levels (anastrozole or exemestane) over the same period in women with invasive breast cancer.
3. Determine the change over time in percent breast density and dense area (from pretreatment to the time period prior to local recurrence) in the contralateral breast in correlation to local recurrence of breast cancer.

Secondary

1. Determine the change over time in percent breast density and dense area in the contralateral breast in correlation to the development of contralateral breast cancer.
2. Determine whether women with high pretreatment percent density (upper tertile) experience greater decreases in percent breast density at 1 and 2 years of aromatase inhibitor therapy than women with low pretreatment percent density (lower tertile).
3. Determine whether women with high pretreatment dense area (upper tertile) experience greater decreases in dense area at 1 and 2 years of aromatase inhibitor therapy than women with low pretreatment dense area (lower tertile).
4. Correlate haplotype tagged single nucleotide polymorphisms in genes in the aromatase pathway (identified thorough the Mayo Clinic and Indiana University Pharmacogenomics Research Network Projects) with changes in percent and area breast density, plasma hormone levels, and 1-year drug levels.

Entry Criteria

Disease Characteristics:

• Histologically confirmed invasive breast cancer



• Completely resected disease



• One intact, noncancerous breast with no prior breast surgery in that breast except breast biopsy
  • Mammogram available taken within 12 months prior to enrollment that includes side- and top-down views of the intact, noncancerous breast



• Estrogen receptor- and/or progesterone receptor-positive tumor

Prior/Concurrent Therapy:

• See Disease Characteristics
• More than 6 months since prior hormone replacement therapy, oral contraceptives, tamoxifen, raloxifene, other selective estrogen-receptor modulators, or gonadotropin releasing-hormone analogues before pre-registration mammogram

Patient Characteristics:

• Female
• Postmenopausal
• Agrees to retrieve and digitize mammograms taken prior to registration (within 12 months prior to atudy entry) and at approximately 1 and 2 years post-registration to this study
• Agrees to have an additional blood banking specimen drawn at the same time as pre-treatment specimens are drawn for parent protocol CAN-NCIC-MA27
• Agrees to have blood sample taken at 12 months post-registration on this study

Expected Enrollment

A total of 550 patients will be accrued for this study.

Outcomes

Changes in breast density measured by percent and area at 1 and 2 years
Correlation of changes in breast density with plasma hormones and drug levels measured by estrone, estrone-sulfate, estradiol, sex hormone binding globulin, anastrozole, or exemestane levels at 1 and 2 years

Correlation of breast density with contralateral breast cancers at 1 and 2 years

Outline

This is a multicenter, companion study.

Patients complete a 10-minute questionnaire about factors that might affect changes in breast density at baseline and another questionnaire at 1 year and 2 years post registration. Blood samples are collected at baseline (before initiation of treatment ) and at 1 year post registration for hormone and drug level analysis. Mammograms taken prior to registration (within 12 months prior to enrollment) and at approximately 1 and 2 years post-registration to this study are retrieved and digitized for determination of percent breast density and dense area.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

James Ingle, MD, Protocol chair		Ph: 507-284-2511 Email: ingle.james@mayo.edu
Celine Vachon, PhD, Protocol co-chair		Ph: 507-284-2511
Paul Goss, MD, PhD, Protocol co-chair		Ph: 617-724-3118; 877-726-5130
Philip Stella, MD, Protocol co-chair		Ph: 734-712-1000 Email: stellap@trinity-health.org
Kathleen Pritchard, MD, Protocol co-chair		Ph: 416-480-4616 Email: kathy.pritchard@sunnybrook.ca

NCIC-Clinical Trials Group

Kathleen Pritchard, MD, Protocol chair		Ph: 416-480-4616 Email: kathy.pritchard@sunnybrook.ca

Related Information

PDQ® clinical trial CAN-NCIC-MA27 (COMPANION)

Registry Information
Official Title		The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27
Trial Start Date		2006-04-24
Trial Completion Date		2010-10-30 (estimated)
Registered in ClinicalTrials.gov		NCT00316836
Date Submitted to PDQ		2005-11-22
Information Last Verified		2008-07-30
NCI Grant/Contract Number		CA25224