Effect of Tamoxifen on Breast Density in Premenopausal Women With Breast Cancer or High Risk for Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00086749
First received: July 8, 2004
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Tamoxifen may be effective in reducing breast density by decreasing estrogen levels.

PURPOSE: This phase I trial is studying how well tamoxifen works in reducing breast density in premenopausal women with breast cancer or at high risk of developing breast cancer.


Condition Phase
Breast Cancer
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Enrollment: 53
Study Start Date: February 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tamoxifen group

Detailed Description:

OBJECTIVES:

Primary

  • Determine whether breast density, as measured by digital mammography, decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction.
  • Determine whether breast density, as determined by a trained mammographer, decreases in patients treated with this drug.
  • Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug.

Secondary

  • Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients.
  • Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels, as measured in the saliva, of patients treated with this drug.

OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast cancer (patients undergoing risk reduction).

Patients undergo mammography to determine breast density at baseline, at 6 and 12 months, and then annually for 4 years. Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels. The results of the salivary hormone studies are correlated with density changes at study completion.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women who are initiating tamoxifen on the advice of their treating physician as the sole systemic treatment for breast carcinoma or breast cancer risk reduction

Criteria

DISEASE CHARACTERISTICS:

  • Initiating tamoxifen as the sole systemic treatment for breast cancer OR for breast cancer risk reduction
  • Undergoing mammography at least annually
  • No bilateral breast cancer or stage IV breast cancer
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 20 to 45

Sex

  • Female

Menopausal status

  • Premenopausal

    • No change in menstrual patterns within the past 6 months

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing

    • No planned pregnancy within the next 5 years
  • No medical or psychiatric disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for breast cancer

Endocrine therapy

  • See Disease Characteristics
  • No prior tamoxifen for more than 1 month in duration

Radiotherapy

  • Not specified

Surgery

  • Not specified
  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: NCT00086749

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Seema A. Khan, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Seema Khan, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00086749     History of Changes
Other Study ID Numbers: NCI 00B2, NU-NCI-00B2, NCI-00B2
Study First Received: July 8, 2004
Last Updated: July 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 16, 2014