Know Cancer

or
forgot password

Molecular Genetic Basis of Invasive Breast Cancer Risk Associated With Lobular Carcinoma in Situ


N/A
N/A
N/A
Open (Enrolling)
Female
Breast Cancer, Lobular Carcinoma, Invasive Breast Cancer

Thank you

Trial Information

Molecular Genetic Basis of Invasive Breast Cancer Risk Associated With Lobular Carcinoma in Situ


LCIS) is a monoclonal pathologic entity which is subject to characterization at the
molecular genetic level, and that these molecular genetic alterations may be used to predict
the subsequent development of invasive breast cancer. Prophylactic mastectomy specimens from
women with multifocal LCIS, and invasive breast cancer specimens which display coexisting
LCIS, will be examined for X-chromosome inactivation patterns and loss of heterozygosity to
assess for monoclonality. If clonality is present, we will assess for microsatellite
instability, and a microarray-based comparative genomic hybridization (CGH) technique will
be used to identify genetic alterations present in LCIS. Lastly, LCIS biopsy specimens from
untreated patients who, after follow-up did or did not develop invasive breast cancer, will
be evaluated to determine whether the nature or extent of any identified genetic alterations
can be correlated with the subsequent development of invasive breast cancer. We hypothesize
that a fraction of LCIS lesions will reflect a monoclonal origin, that those lesions of
monoclonal origin will display evidence of specific molecular genetic alterations, and that
these specific alterations will correlate with the likelihood of the subsequent development
of invasive breast carcinoma.


Inclusion Criteria:



- multifocal lobular carcinoma in situ treated with prophylactic mastectomy or
lumpectomy

- invasive breast cancer (lobular or ductal) with coexisting lobular carcinoma in situ
treated with mastectomy or lumpectomy

- biopsy proven, untreated lobular carcinoma in situ

- invasive lobular cancer with or without coexisting lobular carcinoma in situ treated
with mastectomy or lumpectomy

Exclusion Criteria:

- no paraffin blocks available

- no residual lobular carcinoma in situ in paraffin blocks

- previous or current use of tamoxifen for lobular carcinoma in situ

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To perform analyses using microarray-based gene expression profiling to determine whether a unique mRNA and microRNA gene expression profile distinguishes LCIS from normal breast epithelium and from invasive carcinoma.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Tari King, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

01-135

NCT ID:

NCT00581750

Start Date:

October 2001

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer
  • Lobular Carcinoma
  • Invasive Breast Cancer
  • Biopsy
  • Breast
  • 01-135
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Lobular

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021