Genomic Testing for Primary Breast Cancer

Brief Summary

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

The goal of this research study is find out if researchers can use genetic testing on tumor samples to predict if tumors will respond to breast cancer treatments. The tumor sample will be tested to learn if certain genes are activated (turned on) in the tumor. Researchers hope that the activation of these genes may predict if the tumor will be sensitive or resistant to routine breast cancer treatments, such as chemotherapy or hormonal therapy.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: June 2017

Detailed Clinical Trial Description

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 drugs.

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 tissue.

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 1100 patients will take part in this study. All will be enrolled at MD Anderson.

Interventions Used in this Clinical Trial

  • Procedure: Tumor Biopsy
    • The amount of tumor collected for this study will be about the size of the tip of a pencil.
  • Other: Breast Cancer Registry
    • For 5 years, the study staff will review medical records to see how patients are responding to any breast cancer therapies received.

Arms, Groups and Cohorts in this Clinical Trial

  • Breast Cancer Registry Study for Molecular Predictive Testing
    • Patients scheduled for biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical Stage I to III.

Outcome Measures for this Clinical Trial

Primary Measures

  • Feasibility Analysis of Genomic Predictor from Localized Invasive Breast Cancer Tumor Registry
    • Time Frame: 12 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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; stage IV patients will be allowed and included in the feasibility assessment, but will not be included in outcomes analysis for secondary objectives 1.2.4, 1.2.5 and 1.2.6.

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 received prior systemic therapy or radiation therapy for breast cancer.

3. The patient has a prior history of invasive or metastatic cancer within 5 years of diagnosis of breast cancer, excluding squamous cell or basal cell carcinoma of the skin.

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 or neoadjuvant 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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Collaborator
    • Susan G. Komen Breast Cancer Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stacy Moulder, MD, Principal Investigator, M.D. Anderson Cancer Center
  • Overall Contact(s)
    • Stacy Moulder, MD, 713-792-2817


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