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Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI

This study has been withdrawn prior to enrollment.
(Lack of funding)
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01297231
First received: February 14, 2011
Last updated: November 12, 2012
Last verified: November 2012
History of Changes

February 14, 2011
November 12, 2012
February 2011
February 2014   (final data collection date for primary outcome measure)
To compare the level of BPE on breast MRI [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01297231 on ClinicalTrials.gov Archive Site
To compare the amount of fibroglandular tissue on breast MRI [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI
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

Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These women also commonly have breast MRI to monitor for breast cancer. Some features of normal breast tissue visible on breast MRI change depending on patient hormonal status. It has been questioned if hormonal changes due to tamoxifen are seen on breast MRI. Pilot data suggests this is true. If tamoxifen causes changes in normal breast tissue on MRI, more study could be done looking at whether breast MRI could tell us anything about whether tamoxifen is working.

This study is being done to see if tamoxifen changes normal breast tissue on MRI. It will also look at if other factors like taking anti-depressants or gene type have any effect.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood or saliva
Non-Probability Sample

Eligible premenopausal patients with stage 0-3 breast cancer for whom MRI staging is planned will be enrolled.
Breast Cancer
Other: MRI

Baseline Breast-MRI within 1 year before starting tamoxifen (allows for surgery, chemotherapy and radiation before the start of tamoxifen).

During Tamoxifen Treatment:

  • Blood will be drawn for CYP2D6 genotype testing. Analysis of samples will be performed internally at MSKCC.
  • Follow-up breast MRI after 9-12 months of tamoxifen therapy. In patients whom further breast MRI screening and/or follow-up is clinically indicated, follow-up breast MRIs may be performed within 3 months (before or after) the 2, 3, and 4 year time points during tamoxifen treatment. All breast MRIs will be performed using the same technique.
  • Follow-up for all patients during and after tamoxifen should include routine standard clinical assessment and imaging such as mammography and breast MRI when clinically indicated.
Breast cancer
This prospective study will recruit patients with stage 0-3 breast cancer who have had or are scheduled for a breast MRI prior to treatment.
Intervention: Other: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01297231
10-217, Mskcc 10-217
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Valencia King, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
November 2012

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