Houston, Texas 77030


Purpose:

The goal of this clinical research study is to learn if the use of molecular testing on tumors can improve response to treatment in patients with triple-negative breast cancer (TNBC) by guiding patients with chemotherapy-sensitive tumors to receive standard chemotherapy and chemotherapy-insensitive tumors to consider a clinical trial. Researchers want to compare the outcome of a study group which receive results of these tests with a group of patients who do not receive the results. This is an investigational study. Up to 360 patients will take part in this study. All will be enrolled at MD Anderson.


Study summary:

Study Groups: If you are eligible to take part in this study and agree, you will be randomly assigned (as in a roll of dice) to 1 of 2 study groups (called "arms"). - If you are in Arm A, you will not receive the results of the molecular testing of the tumor described below. - If you are in Arm B, you will receive the results of the molecular testing of the tumor described below. You will have a 1 in 3 chance of being in Arm A and a 2 in 3 chance of being in Arm B. Study Visits: At Baseline (your first visit): - You will have a biopsy for biomarker and molecular testing. Biomarkers are found in the tissue and may be related to the tumor's response to therapy. To perform a biopsy, the affected area is numbed with anesthetic and a sample of tissue is removed using a hollow core needle that has a cutting edge. The biopsy may be an image-guided core biopsy. To perform an image-guided core biopsy, a needle is inserted into the affected area in the breast using imaging such as mammogram, ultrasound, or magnetic resonance imaging (MRI) to collect a small piece of tumor tissue. The doctor will use the imaging to guide the needle into the area. - If an ultrasound has not been performed within 4 weeks, you will also have an ultrasound. You will receive standard-of-care chemotherapy for 4 cycles. A cycle of treatment may be given once every 2 or 3 weeks depending upon your doctor's decision. After Cycle 2, you will have a standard-of-care ultrasound to check the status of the disease. You will receive the results of the ultrasound. If you are receiving your standard-of-care treatment closer to home, then the ultrasound is optional. After Cycle 3 or 4, if you are in Arm B, you will receive the molecular testing results if they are available. After Cycle 4, you will have a standard-of-care ultrasound and will receive the results of that test. Together, you and your doctor will decide if you should go forward with additional standard chemotherapy treatments or consider a clinical trial. If you are in Arm A of this study, you will not have molecular testing to guide your decision to have standard chemotherapy or for selection of a clinical trial. The choice of standard chemotherapy is made by your doctor and the cost will not be covered by the study. The study team will continue to collect information from your medical record throughout the study and for up to 5 years. If the study doctor thinks it is needed, after the first 4 cycles of chemotherapy to help choose treatment options, you will have a standard-of-care biopsy. This biopsy may be an image-guided core biopsy or another type of biopsy depending on the study doctor's decision. If you have this biopsy, an extra tissue sample will be collected and stored in a research bank at MD Anderson for use in future research related to cancer. There will be no cost to you for this procedure. Some of your genetic and health information may be stored in different types of research databases. These databases may be available: - only to MD Anderson researchers - only to researchers who apply and are approved to access the restricted data, no matter if they work in or outside MD Anderson, and/or - publicly on the internet Before your samples and/or data can be used for research, the researchers must get approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee of doctors, researchers, and community members. The IRB is responsible for protecting study participants and making sure all research is safe and ethical. Your samples and data will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank or database will have access to the code numbers and be able to link the samples or data to you. This is to allow medical data related to the samples to be updated as needed. MD Anderson will not include research records in your medical records. Length of Study Participation: At the end of 4 cycles of chemotherapy your study doctor will discuss further treatment options with you. Taking part in this study will not affect your treatment. If you are scheduled to have surgery for the disease, you will still have surgery as scheduled.


Criteria:

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 1.5 cm diameter 3. The patient was proven to have TNBC, defined from standard pathologic assays as negative for ER and PR (<10% tumor staining) and negative for HER2 (IHC score <3, gene copy number not amplified). 4. Primary tumor sample was collected before NACT began and was evaluated for genomic testing (integral biomarker). This allows patients who participate in 2011-0007 to be eligible for study participation. 5. Patients must be >/= 18 years of age. 6. Patients must have LVEF > 50% by MUGA or ECHO within 4 weeks prior to registration. 7. Patients must have adequate organ and marrow function as defined below: • Leukocytes >3,000/mcL • absolute neutrophil count >1,500/mcL • platelets >100,000/mcL • total bilirubin within normal institutional limits • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal • creatinine within normal institutional limits OR • creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. Exclusion Criteria: 1. The patient has diagnosis of stage IV disease or is found to have stage IV disease prior to randomization. 2. Prior history of invasive cancer within 5 years of study entry or history of metastatic cancer. Exceptions include non-metastatic, curatively treated basal and squamous cell carcinoma of the skin. 3. Prior excisional biopsy of the primary invasive breast cancer. 4. Patients with hematomas or biopsy site changes that limit response assessment of the primary tumor by diagnostic imaging. 5. Patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens. 6. Prior therapy with anthracyclines. 7. Grade II or higher neuropathy. 8. Patients with Zubrod performance status of >2. 9. Patients with history of serious cardiac events defined as: • Patients with a history of New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina or CVA within 6 months of protocol registration. • Patients who have history of PR prolongation (grade 2 or higher) or AV block.


NCT ID:

NCT02276443


Primary Contact:

Principal Investigator
Stacy Moulder, MD
M.D. Anderson Cancer Center

Stacy Moulder, MD
Phone: 713-792-2817


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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