Cisplatin vs Paclitaxel for Triple Neg BRCA

Brief description of study

This research study is evaluating how well triple negative breast cancer responds to preoperative treatment with Cisplatin or Paclitaxel chemotherapy, and if use of a research test Homologous Recombination Deficiency (HRD) assay can predict response to preoperative treatment.

Clinical Study Identifier: NCT01982448

Detailed Study Description

Before the research starts (screening, the participant will be asked to undergo some screening tests or procedures to find out if the participant can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that the participant does not take part in the research study. If the participant has had some of these tests or procedures recently, they may or may not have to be repeated. Additional research procedures to be performed at the time of screening: A research tumor biopsy will be taken before the participant beginning study treatment. This is different from the first biopsy done to establish the diagnosis of breast cancer. A research biopsy is required to participate in this research study because the research done on the tumor tissue is a very important part of this research study. The researchers want to learn why some cancers shrink with this study treatment while others do not. Tumor tissue will be collected again for research either during the participant's subsequent breast surgery, or, if the tumor has not responded well to the end of study treatment, by a tumor biopsy before the participant is changed to another regimen. - A small clip may be placed in the tumor bed at the time of the first research biopsy, particularly if one was not placed at the time of the participant's diagnostic biopsy. The clip is placed so that the surgeon can locate the site of the tumor at the time of surgery. This is considered a standard of care procedure for breast cancer. The research biopsy is done in an outpatient setting using a local anesthetic. - If the participant takes part in the study, the investigators will collect a piece of the participant's tumor tissue from their original biopsy and, if there is any tumor remaining at the time of the final surgery, a piece of that as well. As described above, the participant will undergo a breast biopsy and tumor tissue will be collected from that procedure. All of this tissue will be used for research. The research on the participant's sample may include looking at genes (DNA), proteins, or the substances that make proteins (called RNA) in the tissue sample. Collectively, this research is called biomarker research and may help doctors to better understand the disease, how the drug is working in the participant's body, and may help to identify which breast cancers may benefit most from treatment with cisplatin or paclitaxel. Specifically, the researchers will measure the HRD assay by analyzing the tumor tissue, and determine if the results of this assay help predict whether the cancer will respond to the preoperative chemotherapy received. As the researchers do not know whether the results of this test will be predictive, the participant will not receive the results from this research test. The tissue samples will be given the same code as the participant's other study information and kept in locked storage. The tests on the participant's tumor tissue are for research purposes only and would not be done if the participant were not in this study; this is biomarker research. - These tests will be performed at laboratories that may be within or outside of the study center where the participant receive the study drug. The samples will be coded with a unique number. The participant's name or other personal information will not be given to these laboratories, and only the study doctor will be able to identify the participant by this number. This research biopsy is not optional and may be stored for future research. - The participant will have 2 additional tubes of blood collected for research purposes. These research blood samples may be collected at any time during the course of this research study. The blood that is being collected so researchers can look at the participant's DNA. It is important to have the DNA in order to compare it to the DNA in the participant's tumor. The investigators will also be performing genetic testing on one of the blood samples, looking for gene mutations which may increase risk of developing certain types of cancers. The blood may also be used for future research studies. The blood will be stored by the study sponsor or its authorized agents until it has been exhausted. This research blood collection is not optional and may be stored for future research. The participant will be "randomized" to receive either Cisplatin or Paclitaxel chemotherapy prior to removal of their breast cancer. Chemotherapy administered before removal of the cancer is known as preoperative chemotherapy. Study Drugs: - Cisplatin: If the participant is randomized to receive Cisplatin, the participant will receive Cisplatin once every 3 weeks for a total of 4 doses. Note, doses can also be referred to as cycles. The participant will be given Cisplatin by vein (IV). The Cisplatin infusion can take approximately 1 hour. Before and after receiving Cisplatin, the participant will receive fluid hydration by vein, and the participant will also be given medicine to help prevent side effects such as nausea. The total time of the infusion of Cisplatin and the additional fluid and medications will take approximately 6 hours. - Paclitaxel: If the participant is randomized to receive Paclitaxel, the participant will receive Paclitaxel once a week for 12 weeks for a total of 12 doses. The participant will be given Paclitaxel by vein. The Paclitaxel infusion can take approximately 1 hour. - The study treatment will be stopped if the participant has serious side effects or if the tumor grows despite receiving Cisplatin or Paclitaxel chemotherapy. The participant's doctor will then discuss with the participant alternative treatment options. - Physical exams: Every 3 weeks, and approximately 2-4 weeks after the last chemotherapy dose, the participant will have a physical exam (including weight and vital signs, as well as tumor measurements) and the participant will be asked general questions about their health and any medications the participant may be taking, as well as specific questions about any side effects the participant may be experiencing while receiving study treatment. - Blood tests: Prior to each cycle of chemotherapy, the participant will have standard blood tests to check their blood counts. About 1 tablespoon of blood will be drawn for these tests. - Surgery to Remove Tumor: This will occur within six weeks after the last dose of chemotherapy (either Cisplatin or Paclitaxel). The participant and their surgeon will decide on the type of surgery (i.e. lumpectomy or mastectomy) as the participant would as part of standard care for their disease. - After receiving the total course of Cisplatin or Paclitaxel chemotherapy, if the response in the breast cancer is not adequate before surgery, there is the option to receive additional chemotherapy outside of the trial prior to surgery. This is a decision the participant can make with their treating physicians. If it is determined that additional chemotherapy is needed, a second biopsy of the tumor tissue will be performed before the next chemotherapy is started. - Tumor assessments: The treating physician or nurse practitioner will examine the participant every 3 weeks. A measurement of their tumor will be performed as part of their physical exam. When the tumor is removed, a research sample will be obtained from the hospital and used to confirm the participant's response to the chemotherapy that the participant has received. It will also be used to see if the investigators can learn which breast cancers are likely to respond to either Cisplatin or Paclitaxel. Tumor specimens from the initial breast cancer biopsy and from surgery after chemotherapy will be sent to the study pathologist so that the response of the tumor to the study treatment can be assessed. After these tumor specimens are reviewed, they will be returned to the hospital at which the biopsy and surgery were performed.

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To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: Cisplatin vs Paclitaxel for Triple Neg BRCA
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