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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00316836
First received: April 19, 2006
Last updated: July 13, 2015
Last verified: July 2015
  Purpose

RATIONALE: Understanding the relationship between breast density, levels of hormones in the blood, and levels of anticancer drugs in the blood may help improve the ability to plan effective treatment for women with invasive breast cancer.

PURPOSE: This clinical trial is studying the relationship between breast density and blood levels of hormones and anticancer drugs in women with invasive breast cancer who are receiving exemestane or anastrozole.


Condition Intervention
Breast Cancer
Procedure: mammography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Changes in breast density measured by percent and area at 1 and 2 years [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of breast density with contralateral breast cancers at 1 and 2 years [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples


Estimated Enrollment: 550
Study Start Date: April 2006
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
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.
Procedure: mammography

Detailed Description:

OBJECTIVES:

Primary

  • 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.
  • 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.
  • 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

  • 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.
  • 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).
  • 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).
  • 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.

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.

PROJECTED ACCRUAL: A total of 550 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
Sampling Method:   Non-Probability Sample
Study Population

Patients with diagnosed with breast cancer.

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

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316836

  Show 324 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
NCIC Clinical Trials Group
Investigators
Study Chair: James N. Ingle, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00316836     History of Changes
Other Study ID Numbers: NCCTG-N0434, NCCTG-N0434, CAN-NCIC-MA27D, CDR0000462330
Study First Received: April 19, 2006
Last Updated: July 13, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on August 02, 2015