Recruiting

Tamoxifen & Letrozole

Sponsor:

Massachusetts General Hospital

Code:

NCT00897065

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

microarray analysis

polymerase chain reaction

protein expression analysis

diagnostic laboratory biomarker analysis

fluorescent antibody technique

Study Details

Brief summary:

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers that may predict response to tamoxifen and letrozole in postmenopausal women with primary breast cancer treated on clinical trial CAN-NCIC-MA17.

Conditions

Breast Cancer

Study ID

NCT00897065

Start date

Jun, 2006

Status verified date

Apr, 2008

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis
  • Treated on clinical trial CAN-NCIC-MA17
  • Hormone receptor status:

  • Estrogen or progesterone receptor positive tumor

PATIENT CHARACTERISTICS:

  • Female
  • Postmenopausal

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Design

Enrollment

957 participants

Anticipated

Interventions and Outcome Measures

Interventions

microarray analysis

polymerase chain reaction

protein expression analysis

diagnostic laboratory biomarker analysis

fluorescent antibody technique

immunohistochemistry staining method

immunologic technique

Primary outcome measure

  • Prognostic utility of the MGH 2-gene and the GHI 21-gene expression signatures [ Time Frame: undefined ]
  • Ability of the MGH 2-gene and the GHI 21-gene expression signatures to predict responsiveness to letrozole [ Time Frame: undefined ]
  • Prognostic utility of quantitative immunofluorescence vs standard immunohistochemistry of estrogen receptor, progesterone receptor, HER-2, tumor aromatase, cyclooxygenase-2, GATA-3, and NAT-1 [ Time Frame: undefined ]
  • Ability of quantitative immunofluorescence and standard immunohistochemistry of these proteins to predict responsiveness to letrozole [ Time Frame: undefined ]
  • Novel gene expression profiles that may predict outcome and responsiveness to letrozole [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Clinical Trials Office - Massachusetts General Hospital

877-726-5130

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 10, 2013

Last verified

Apr, 2008

Keywords

  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • estrogen receptor-positive breast cancer
  • progesterone receptor-positive breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2013-07-10.