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Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI in Early Stage Breast Cancer Patients on Tamoxifen


N/A
21 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI in Early Stage Breast Cancer Patients on Tamoxifen


Inclusion Criteria:



- Females with stage 0-3 breast cancer who have had or are planned to have a breast MRI
within 1 year prior to starting tamoxifen

- Premenopausal status is defined as intact ovaries and still menstruating

- Clinical and MRI follow-up planned at MSKCC or MCKCC regional facility

- Willing and able to undergo all study procedures

Exclusion Criteria:

- Contraindication to breast MRI (such as non-compatible cardiac pacemakers or
intracranial vascular clips, allergy to Gadolinium)

- Bilateral breast cancer or treatment such as:

- History of or planned bilateral breast irradiation

- History of or planned bilateral mastectomy

- Bilateral breast cancer

- History of unilateral mastectomy or radiation treatment with contralateral breast
cancer

- Taking chemo- or hormonal therapy at the time of the baseline breast MRI

- Estrogen and progesterone receptor negative breast cancer

- GFR less than GFR < 30 mL/min/1.73m2

- Postmenopausal women

- Pregnant and/or nursing women

- Less than 21 years of age

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To compare the level of BPE on breast MRI

Outcome Description:

on breast MRI in premenopausal patients with breast cancer before and during 9-12 months on tamoxifen to determine whether tamoxifen results in a significant decrease in BPE and/or amount of fibroglandular tissue

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Valencia King, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

10-217

NCT ID:

NCT01297231

Start Date:

February 2011

Completion Date:

February 2014

Related Keywords:

  • Breast Cancer
  • fibroglandular tissue
  • tamoxifen
  • MRI
  • Background Parenchymal Enhancement
  • 10-217
  • Breast Neoplasms

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