Clinical Trials and Research

The Saul and Joyce Brandman Breast Center is dedicated to bringing new diagnosis and treatment techniques and technology to our patients through clinical trials and research. Clinical trials lead the way to better treatments and better survival for breast cancer patients.

The following is a list of currently open clinical trials and research studies.

Your surgeon may recommend a sentinel node biopsy to remove lymph nodes likely to contain cancer. These lymph nodes are normally checked by a Pathologist who takes one or more thin slices (like cutting a loaf of bread into slices) and looks at these slices under a microscope. The GeneSearch Breast Cancer Lymph Node Assay is a new FDA approved test to identify DNA from cancer cells in lymph nodes. In this study, we will be comparing the GeneSearch Assay with the standard pathologist's evaluation to determine which is more effective.

(IRB# Pro00016982) PI: Scott Karlan, MD
(IRB# Pro00018068) PI: Scott Karlan, MD

Inclusion Criteria

• Recently diagnosed with breast cancer
• Scheduled for sentinel biopsy or axillary dissection
• Male or Female
• 18 years of age or older

Exclusion Criteria

• Previous diagnosis of lymphoma
• Patients who have had any pre-operative treatment for breast cancer including neoadjuvant and/or hormonal intervention such as aromatase inhibitors or tamoxifen
• Participating in other research studies that would interfere with their full participation in this study

When surgeons perform a lumpectomy (surgical removal of a tumor from the breast) for breast cancer, they try to remove some of the normal appearing tissue around the tumor. They do this to assure that no part of the tumor is left behind, as some tumors have microscopic portions which are difficult to see or feel during surgery. As a result, many patients (approximately 25%) need more than one operation to gain adequate margins (a rim of healthy tissue free of cancer). This study plans to use an investigational device, the MarginProbe, to help surgeons determine whether they have removed the entire tumor during a lumpectomy.

(IRB# Pro00017572) PI: Scott Karlan, MD

Inclusion Criteria

• Women with recently-diagnosed invasive or in-situ breast carcinoma
• Scheduled for lumpectomy (partial mastectomy), for non-palpable lesions requiring image guided localization
• Age 18 years or older

Exclusion Criteria

• Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
• Bilateral disease (diagnosed cancer in both breasts)
• Neoadjuvant systemic therapy
• Previous radiation in the operated breast
• Prior surgical procedure in the same breast
• Implants in the operated breast
• Pregnancy
• Lactation
• Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

The investigators listed above are collecting blood, tissue, and other body fluids including saliva, and clinical information. The purpose of this study is to identify genes and/or other proteins/molecules that influence a person's risk of getting cancer of the breast, to discover new tests and treatments for breast cancer, to further our understanding of breast cancer and learn whether we can predict how individuals with a particular cancer of the breast will respond to treatments.

(IRB# 3870) PI: Beth Karlan, MD

Inclusion Criteria:

• You are scheduled to have a surgical procedure that may involve the removal of some or all of your breast tissue
• You are a man or woman with a family history of breast cancer
• You are a patient being seen in the Saul and Joyce Brandman Breast Center for breast health evaluation or care

This research is being done to evaluate standard and new screening methods, which may detect ovarian, peritoneal or breast cancer at an early stage in women who are at high risk because they have known BRCA1 or BRCA2 genetic alterations, which predispose for these diseases.

(IRB# 1080) PI: Beth Karlan, MD

Inclusion Criteria:

• A known BRCA1 or BRCA2 mutation

This research study is designed to compare a new imaging test, the Lumagem® dual headed small field gamma camera, with conventional breast imaging (mammography, ultrasound and/or MRI) to see which is more effective in detecting small breast tumors.

(IRB# Pro00017011) PI: Alan Waxman, MD

Inclusion Criteria:

• Women
• 18 years of age or older
• With a suspicious abnormality on physical exam or conventional imaging (mammogram, ultrasound or MRI)
  a. Unilateral or Bilateral
  b. Less than 2cm in size
  c. Imaging rated BIRADS category 4 or 5
• Not pregnant
  a. Negative pregnancy test in patients of child bearing capability
  b. Post menopausal women
  c. Women who have had prior hysterectomy
  

Exclusion Criteria:

• Currently lactating
  
• Prior needle biopsy of the lesion in question

For a listing of additional breast cancer clinical trials, please click here On that page, please click on "Search for Clinical Trials/Studies at Cedars-Sinai" and on the following page, type "Breast Cancer" into the search box.

For information concerning breast cancer clinical trials at Cedars-Sinai Medical Center, Please contact: