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Feasibility, Validation and Implementation of Genomic Testing for Chemotherapy and Endocrine Sensitivity of HER2 Negative Primary Invasive Breast Cancer (Clinical Stage I to III)

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Feasibility, Validation and Implementation of Genomic Testing for Chemotherapy and Endocrine Sensitivity of HER2 Negative Primary Invasive Breast Cancer (Clinical Stage I to III)

This study will involve performing a test on a sample of tumor. If you agree to take part in
this study, you will have a tumor biopsy before you receive any drugs to treat breast
cancer. The sample of the tumor will be will be taken at one of the following times:

- At the time of a planned biopsy to learn if you have breast cancer.

- At the time of planned surgery to remove a known breast cancer.

- If the breast cancer has been previously biopsied and your doctor plans to give you
breast cancer treatments before surgery, you will have a biopsy before starting these

The amount of tumor collected for this study will be about the size of the tip of a pencil.

If you are going to have surgery to remove the breast cancer before receiving breast cancer
treatments, a small piece of the tumor will be removed and sent for testing. If you are
going to have a planned needle biopsy, an extra core sample and/or fine needle sample will
be taken. If you are going to have a research biopsy, an ultrasound or mammogram will be
used to find the tumor and a needle will be inserted into the tumor to collect a piece of

After the genetic testing is complete, researchers will use the results to learn how well
this test is able to give results that can be used to predict response to breast cancer
drugs and therapy.

Test Results:

Because this is an investigational test, neither you or your doctor will be told the results
of this test. This test will also not be used to guide your doctor's choice of therapy.
This study will only look at how well this test was able to predict the response of the
tumor to breast cancer treatment.

For 5 years, the study staff will review your medical record to see how you are responding
to any breast cancer therapies that you receive. If you are treated outside MD Anderson, you
will be called and asked how you are doing. This phone call should take about 5 minutes.

To protect your privacy, all information stored as part of this study will be kept secure
and confidential.

Length of Study:

You will be off study after the 5 years of follow-up.

This is an investigational study. The test that will be performed on your breast cancer
tumor sample is an investigational test.

Up to 500 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. The patient can undergo biopsy or surgery of a primary tumor site for suspected or
proven invasive breast cancer of clinical Stage I to III

2. The clinical or radiologic primary tumor size is at least 1 cm diameter

Exclusion Criteria:

1. The patient has proven HER2-positive breast cancer, defined as a pathology report of
amplification of the gene or 3+ score for immunohistochemical staining.

2. The patient has diagnosis of stage IV disease

3. The patient has a prior history of invasive or metastatic breast cancer.

4. The patient had prior excisional biopsy of the primary invasive breast cancer.

5. There is hematoma or biopsy site changes that obscure the primary tumor.

6. Patients deemed medically ineligible for any adjuvant therapy. Patients with ER+
tumors deemed medically eligible for hormonal therapy, but not chemotherapy will be
considered eligible for this protocol. Patients with ER- tumors who are not
candidates for adjuvant anthracycline based chemotherapy will be considered
ineligible for this protocol. Patients who undergo biopsy and are later found to be
ineligible for adjuvant therapy will be assessed for the primary objective, but will
be excluded from the secondary objectives.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Feasibility Analysis of Genomic Predictor from Localized Invasive Breast Cancer Tumor Registry

Outcome Description:

Success is defined as the ability to classify patients into 1 of 4 cohorts (Groups A-D) based on results from genomic analyses of their breast cancer sample. Feasibility will be defined as achieving a minimum success rate from acceptable samples of primary tumor in a sufficiently large cohort of eligible patients (n=300) spanning at least 12 months of patient accrual.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Stacy Moulder, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2011

Completion Date:

Related Keywords:

  • Breast Cancer
  • Genomic Testing
  • Genetic Testing
  • HER2 Negative
  • Primary Invasive Breast Cancer
  • Stage I
  • Stage II
  • Stage III
  • Registry
  • Biopsy
  • Tumor sampling
  • Breast Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030