Genomic Testing for Primary Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01334021
Recruitment Status : Active, not recruiting
First Posted : April 12, 2011
Last Update Posted : May 14, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.

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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Tumor Biopsy Other: Breast Cancer Registry

Detailed 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.

Study Type : Observational
Actual Enrollment : 554 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : May 31, 2011
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.
Procedure: Tumor Biopsy
The amount of tumor collected for this study will be about the size of the tip of a pencil.
Other Names:
  • Sampling
  • Surgical Biopsy

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.
Other Name: Database

Primary Outcome Measures :
  1. Feasibility Analysis of Genomic Predictor from Localized Invasive Breast Cancer Tumor Registry [ Time Frame: 12 months ]
    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.

Biospecimen Retention:   Samples With DNA
Tumor biopsy performed before receiving any drugs to treat breast cancer.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast cancer patients from UT MD Anderson Cancer Center in Houston, Texas

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01334021

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Stacy Moulder, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01334021     History of Changes
Other Study ID Numbers: 2011-0007
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Genomic Testing
Genetic Testing
HER2 Negative
Primary Invasive Breast Cancer
Stage I
Stage II
Stage III
Tumor sampling

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases