<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Genomic</span> testing looks at <span class="highlight">genetic</span> mutations within your tumor.</li> <li class="seamTextUnorderedListItem">The drug you receive will be determined by the results of your tumor's <span class="highlight">genomic</span> test. </li> <li class="seamTextUnorderedListItem">Your may receive one or more of the following drugs: Adavosertib, Afatinib, Binimetinib, Capivasertib (AKT inhibitor), Copanlisib, Crizotinib, Dabrafenib, Dasatinib, Defactinib, Erdafitinib, FGFR Inhibitor AZD4547, Larotrectinib, Nivolumab, Osimertinib, Palbociclib (CDK inhibitor), Pertuzumab (anti-HER2), PI3K-beta Inhibitor GSK2636771, Sapanisertib, Sunitinib Malate, Taselisib, Trametinib, Trastuzumab emtansine/T-DM1 (Kadcyla®) (antibody-drug conjugate (ADC)), Vismodegib</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ABL, ALK, BRAF, CDK4, CDK6, CSF-1R, EGFR, EGFR T790M, FGFR, FLT3, HER2 (ERBB2), KIT, MET, MEK, mTOR, NTRK fusions, PD-1, PDGFR, PI3K, PTCH1, PTEN loss, RET, ROS1, SMO, TRK, VEGFR, WEE1</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02465060' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match' target='_blank'>National Cancer Institute Study Website: NCI-Match</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/nci-match-eay131' target='_blank'>ECOG-ACRIN Cancer Research Group: NCI-Match</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/diagnosis/genomic_assays' target='_blank'>Breastcancer.org: Tumor Genomic Assay Testing</a> </li></ul>

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy you receive will be selected based on your tumor's specific <span class="highlight">genetic</span> profile.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Afatinib, Crizotinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab, Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, HER2 (ERBB2), high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02693535' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tapur.org/' target='_blank'>ASCO Study Website: TAPUR</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/conference-coverage/asco-2016/dr-edward-kim-on-ascos-tapur-trial' target='_blank'>OncLive: About TAPUR (video)</a> </li></ul>

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A group of doctors will make a treatment decision for you by studying your tumor's <span class="highlight">genetic</span> profile (this is called <span class="highlight">genomic</span> testing).</li> <li class="seamTextUnorderedListItem">The group of doctors will choose 2 drugs out of 35 to give to you. </li> <li class="seamTextUnorderedListItem">The types of drugs available include: targeted therapies, immunotherapies, and chemotherapies. </li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket studies enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ABL, BCL2, BRAF, CDK4, CDK6, COX-2, CSF-1R, CTLA-4, EGF, EGFR, FGFR, FLT3, HDAC, HER2 (ERBB2), JAK1/2, KIT, MEK, MET, mTOR, PARP, PD-1, PDGFR, PI3Kdelta, RAF, RET, VEGF, VEGF ligand, VEGFR</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03878524' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ohsu.edu/spatial-systems-biomedicine-center/serial-measurements-molecular-and-architectural-responses' target='_blank'>Oregon Health & Science University: SMMART program</a> </li><li class='seamTextUnorderedListItem'><a href='https://news.ohsu.edu/2018/11/16/making-cancer-clinical-trials-smmart' target='_blank'>Oregon Health & Science University NEWS: Making cancer clinical trials SMMART</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/diagnosis/genomic_assays' target='_blank'>Breastcancer.org: Tumor Genomic Assay Testing</a> </li></ul>

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug is pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy drug called a PD-1 inhibitor. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1). </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1/2 tumor (not inherited), POLE, POLD1</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03428802' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/july-10-2017/pembrolizumab-moving-forward-in-triple-negative-breast-cancer/' target='_blank'>ASCO: Keytruda for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/parp-inhibitor-may-prolong-survival-in-metastatic-brcapositive-breast-cancer' target='_blank'>Cure Today: Parp Inhibitor May Prolong Survival</a> </li></ul>

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461 is an experimental targeted therapy. </li> <li class="seamTextUnorderedListItem">It targets cells with a Homologous Recombination Deficiency (HRD) mutation. </li> <li class="seamTextUnorderedListItem">It works by slowing down the growth of cancer cells or causing cancer cells to die.</li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of advanced cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA2, PALB2</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04890613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/senhwa-biosciences-receives-us-fda-study-may-proceed-letter-to-treat-brca2-or-palb2-solid-tumors-with-cx-5461-301198347.html' target='_blank'>Senhwa Biosciences Press Release: CX-5461</a> </li></ul>

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat metastatic HER2 negative breast cancer in people with a BRCA 1/2 <span class="highlight">genetic</span> (inherited) mutation. However, the use of olaparib in this trial is considered investigational. </li> <li class="seamTextUnorderedListItem">Vorinostat (Zolinza®) is chemotherapy approved to treat a type of cancer called T-cell lymphoma. Its use in this trial is considered investigational.</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742245' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/lynparza' target='_blank'>Breastcancer.org: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/Vorinostat.aspx' target='_blank'>Chemocare: Vorinostat</a> </li></ul>

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy known as a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">PARP helps repair DNA when it becomes damaged. Studies showed that the tumors in individuals who have inherited or acquired a mutation in the BRCA1 or BRCA2 genes are often sensitive to killing by PARP inhibitors.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat recurrent ovarian cancer. </li> <li class="seamTextUnorderedListItem">Patients with inherited BRCA1/2 mutations are NOT eligible for this study</li> <li class="seamTextUnorderedListItem">Mutations or deficiencies being studied: somatic BRCA1/2 mutation, ATM, ATR, BARD1, BRIP1 (FANCJ), CHEK2 , FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11A, NBN, PALB2, RAD50, RAD51C, RAD51D, plus other HR-related genes.</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03344965' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/risk/factors/genetics' target='_blank'>Breastcancer.org: Genetics</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2018/fda-olaparib-breast-brca-mutations' target='_blank'>NCI: Olaparib Approved for Treating Some Breast Cancers with BRCA Gene Mutations</a> </li></ul>

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ad-p53 is a type of gene therapy.</li> <li class="seamTextUnorderedListItem">Gene therapy is a treatment that inserts <span class="highlight">genetic</span> material (DNA or RNA) directly into your cells to prevent or fight disease.</li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy called a checkpoint inhibitor. They get the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). </li> <li class="seamTextUnorderedListItem">PD-L1 inhibitors are also checkpoint inhibitors. They stimulate your immune system to go after cancer cells by blocking a protein called PD-L1 (programmed death-ligand 1).</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced and metastatic cancer.</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03544723' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ad5cmv-p53-gene' target='_blank'>NCI Drug Dictionary: Ad-p53</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertodaymag.org/Pages/cancer-talk/First-Immunotherapy-Approved-for-Breast-Cancer.aspx' target='_blank'>Cancer Today: First Immunotherapy Approved for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/PD-1_and_PD-L1_inhibitors' target='_blank'>Wikipedia: PD-1 and PD-L1 inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gene-therapy' target='_blank'>NCI Dictionary of Cancer Terms: Gene Therapy</a> </li></ul>

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Molecular profiling of a tumor may identify <span class="highlight">genetic</span> mutations or biomarkers that suggest the tumor is likely to respond to a currently available targeted therapy. </li> <li class="seamTextUnorderedListItem">It is not known if choosing metastatic breast cancer treatment based on the tumor's molecular profile is more effective than the current standard of care. </li> <li class="seamTextUnorderedListItem">All people who enroll in this study will have molecular profiling performed on a biopsy of their tumor. </li> <li class="seamTextUnorderedListItem">If there is no mutation or biomarker found, you will receive the treatment the doctor determines is the best option. </li> <li class="seamTextUnorderedListItem">If a mutation or biomarker is found and there is an FDA-approved drug for the tumor type, you will be offered that treatment. </li> <li class="seamTextUnorderedListItem">If there is a mutation or biomarker found but no FDA-approved drug that targets it, you will be randomly assigned to either a targeted therapy or the standard of care.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: vary based on test results.</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02152254' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3825646/' target='_blank'>Journal Article: Molecular Profiling for Breast Cancer</a> </li></ul>

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To create the personalized T cells, cancer cells will be taken from your tumor and white blood cells will be removed from your blood. </li> <li class="seamTextUnorderedListItem">The cancer cells will be analyzed to learn about the <span class="highlight">genetic</span> mutations they contain. </li> <li class="seamTextUnorderedListItem">In a lab, your white blood cells will be modified in ways that will help them go after your tumor cells. </li> <li class="seamTextUnorderedListItem">They will then be infused into your body. This will take place in the hospital where the research study is taking place. </li> <li class="seamTextUnorderedListItem">When you receive the infused T cells, you will also be given Aldesleukin, an immune function enhancing drug. </li> <li class="seamTextUnorderedListItem">Your treatment will also include two chemotherapy drugs: cyclophosphamide (Cytoxan), which is used to treat breast cancer, and fludarabine (Fludara), which is approved to treat chronic lymphocytic leukemia (CLL). </li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of metastatic cancer.</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03412877' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2014/ACTepithelial' target='_blank'>National Cancer Institute Press Release: Immunotherapy</a> </li></ul>

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gene therapy is a treatment that inserts <span class="highlight">genetic</span> material (DNA or RNA) directly into your cells to prevent or fight disease.</li> <li class="seamTextUnorderedListItem">Gene therapy with KK-LC-1 T cell receptor (TCR) T cells is an experimental type of immunotherapy that train the immune system to attack KK-LC-1 positive cancer cells.</li> <li class="seamTextUnorderedListItem">About 75% of triple negative breast cancer is KK-LC-1 positive.</li> <li class="seamTextUnorderedListItem">Leukapheresis is the removal of blood by a machine to collect specific immune cells called T cells that will be modified to target cancer cells.</li> <li class="seamTextUnorderedListItem">The T cells will be grown in a lab, modified, and given back to you through an injection into your tumor.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) are chemotherapy drugs. The main purpose of chemotherapy drugs in this trial is to make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2) may help the T cells live longer in your body.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA</li></ul>

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05035407' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/therapy/genetherapy/#:~:text=Gene%20therapy%20is%20a%20medical,of%20using%20drugs%20or%20surgery.' target='_blank'>MedlinePlus: What is Gene Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>National Cancer Institute: T Cell Transfer Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41598-018-24514-9' target='_blank'>Journal Article: KK-LC-1 Positive Cancer Cells</a> </li></ul>