2018;379:111–21. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Desmoid tumors 28. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. that evaluated CMF chemotherapy in node-positive patients is included. N Engl J Med. J Clin Oncol. Research has looked at whether drugs could prevent breast cancer in women with an increased risk of the disease. Effect of Radiotherapy After Mastectomy and Axillary Surgery on 10-year Recurrence and 20-year Breast Cancer Mortality: Meta-analysis of Individual Patient Data from 8135 Women in 22 Randomized Trials. Krag D, et al. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer. 2017;389:1195–205. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual) 27. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Fisher B, et al. Clinical trials are research studies that involve people. Clinical trials look at new ways to prevent, detect, or treat disease. The Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741 and a meta-analysis by Mauri et al. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the program. pp 7-40 | Location: 21 locations, The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success. Lancet Oncol. Cancer and Leukemia Group B (CALGB) 9343: Lumpectomy plus tamoxifen with or without irradiation in women age 70 years or older with early breast cancer: long-term follow-up of CALGB 9343. J Clin Oncol. For 2 years, Tyler participated in the trial that used a drug that had previously been used for stage 4 breast cancer patients. J Natl Cancer Inst. Three studies are included that lessened the burden of surgery including the NSABP B-04, NSABP B-06, and NSABP B-32 trials. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. The Breast Cancer Locator study is a prospective, 1:1 randomized, controlled pivotal trial that will enroll 448 women with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS) … Basal cell carcinoma (temporarily closed to accrual 04 / 29 / 2020) 42. Gunter von Minckwitz et al. Giving trastuzumab, vinorelbine tartrate, and avelumab with or without utomilumab may work better in treating patients with breast cancer. Location: 848 locations, This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Location: 147 locations, This randomized phase III trial studies proton beam radiation therapy (proton therapy) compared to photon beam radiation therapy (photon therapy) in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Malignant giant cell tumors 30. Participants with ER+/HER2- breast cancer … Abstract. Every year researchers from more than 90 countries come together for the San Antonio Breast Cancer Symposium. While doctors are still unclear on what causes breast cancer, research has allowed them to get a … 1999;353:1993–2000. Location: 1083 locations, This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. The FDA has approved a triple-negative breast cancer vaccine for use in human clinical trials. Breast Cancer Trials currently has one immunotherapy trial … Trials measured cancer severity in terms of clinical stage (0 to IV), 23, 24, 68, 69 number of involved lymph nodes (0, 1 to 3, or ≥4), 18, 20, 25, 26, 70 and tumor size (mm), 19, 21, 26 and these varied across trials. In response to COVID-19, some breast cancer trials have temporarily stopped enrolling new patients. 4 mg/m 2 administered intravenously during 2–5 min on days 1 … Bonadonna G, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Peritoneal mesothelioma (temporarily closed to accrual 05 / 08 / 2020) 41. Location: 28 locations, This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. Small cell lung cancer is not eligible (temporarily closed to accrual 03 / 25 / 2020) 52. US - Breast Cancer Clinical Trials Overview 5.1 By Drug Class 5.2 By Formulation 5.3 By Organization 5.4 By Patient Segment 5.5 By Phase 5.6 By Target 6. The clinical trial will take place in three Canadian centers, including the Cross Cancer Institute in Edmonton, and will enroll patients with advanced and previously treated lymphoma, breast, … Over 10 million scientific documents at your fingertips. Clear cell cervical cancer 43. Cleveland Clinic researchers are getting ready to embark on a clinical trial testing a breast cancer vaccine. Dale Shepard, MD, PhD: So in terms of reaching out specifically to patients within breast cancer trials and breast cancer care, how big of a role does social media, patient support groups, how big of a role does that play in terms of patient awareness of a trial … 2002b;347(16):1233–41. Location: 23 locations, This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1 / 2 / 3, ROS1, or ALK gene fusion. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07 / 27 / 2018) 21. Undifferentiated carcinoma of gastrointestinal (GI) tract 5. These studies help improve the overall standard of care. Location: 1201 locations, This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. 2005;97:188–94. Location: 30 locations, This phase II trial studies the how well trastuzumab, vinorelbine tartrate, and avelumab with or without utomilumab work in treating patients with HER2-positive breast cancer that has spread to other parts of the body (metastatic). Trials measured cancer severity in terms of clinical stage (0 to IV), 23, 24, 68, 69 number of involved lymph nodes (0, 1 to 3, or ≥4), 18, 20, 25, 26, 70 and tumor size (mm), 19, 21, 26 and these varied across trials. Mauri D, et al. NSABP trials were among the first to demonstrate that the oral hormonal therapy, tamoxifen, could reduce the risk of breast cancer recurrence and improve survival. Hormone therapy using fulvestrant or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. Cameron D, et al. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells. Gastrointestinal stromal tumor (GIST) (closed to accrual 09 / 26 / 2018) 38. N Engl J Med. 2017;318(10):918–26. The reader is encouraged to refer to the full manuscript of these trials for a greater understanding. Gestational trophoblastic disease (GTD) 47. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment. Not affiliated N Engl J Med. The clinical trials on this list are for breast cancer. J Clin Oncol. At the moment they recommend that women at high or moderate risk of breast cance… Location: 544 locations, This randomized phase III trial studies if not giving regional radiotherapy is just as good as using regional radiotherapy in keeping breast cancer from coming back in patients with estrogen receptor (ER) positive, HER2 negative node positive low risk breast cancer who have undergone breast conserving surgery or mastectomy. Location: 245 locations, This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Fisher B, et al. Proton therapy is a type of radiation therapy that uses multiple beams of protons (tiny particles with a positive charge) to kill tumor cells. Tamoxifen has been the most commonly prescribed breast cancer drug in the world and this had a major impact on reducing the number of deaths due to breast cancer. 2017;3(11):1503–10. Utolimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The vaccine was developed by researchers at the Cleveland Clinic in Ohio and works by training the … For more information on participating in a trial … 2015;372:724–34. Adenocarcinoma with variants of small intestine (closed to accrual 05 / 10 / 2018) 6. the ACOSOG Z0011 (Alliance) randomized clinical trial. The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Photon therapy is also a type of radiation therapy which uses multiple x-ray beams to kill tumor cells. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma 13. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body’s immune system. Breast Cancer Clinical Trials Death rates from breast cancer have reduced greatly in the last couple of decades, and that has been made possible in part thanks to the medical advances that resulted from clinical trials … Paraganglioma (closed to accrual 11 / 29 / 2018) 26. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03 / 20 / 2018) 11. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10 / 17 / 2018) 7. Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer … This service is more advanced with JavaScript available, Landmark Trials in Oncology Three studies are included that lessened the burden of surgery including the NSABP B-04, NSABP B-06, and NSABP B-32 trials. Immunotherapy with monoclonal antibodies, such as avelumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. US - Breast Cancer Clinical Trials … 2017;377:122–31. The Food and Drug Administration (FDA) recently greenlighted a breast cancer vaccine technology developed at Cleveland Clinic, which allows clinical trials … Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. Earlier data from the trial, led to the FDA approval of the antibody-drug conjugate in December 2019 in adult patients with unresectable or metastatic HER2-positive breast cancer who … Trials have looked at hormone therapies including: 1. tamoxifen 2. raloxifene 3. anastrozole (Arimidex) The results show that these drugs can lower the risk of breast cancer in women at high risk. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Lancet. Study Summary: The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better … We have provided a summary of key annoucements. The IES trial was designed as an international, multicenter, randomized, double‐blind trial to compare the efficacy and safety of continued adjuvant tamoxifen therapy with exemestane therapy in postmenopausal women with primary breast cancer … JAMA. Epithelial tumors of major salivary glands (closed to accrual 03 / 20 / 2018) 3. J Clin Oncol. Use of molecular tools to identify patients with indolent breast cancers with ultralow risk over 2 decades. Clinical trials test the safety and benefits of new treatments as well as new combinations (or new doses) of standard treatments. Management of breast cancer is changing rapidly. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. Treatment of lymph node negative, oestrogen-receptor positive breast cancer: long term findings from National Surgical Adjuvant Breast and Bowel Project randomized clinical trials. Lancet. 2015;386:1341–52. Background: Breast cancer patients have a lifelong 2-4-fold increased risk of developing a second primary tumor in the contralateral breast compared with the risk for a first primary breast cancer in the general female population. The current trial hypothesizes that "Post-mastectomy radiation in high risk, node negative early breast cancer patients decreases rates of loco-regional recurrence and improves disease free … The National Institute for Health and Clinical Excellence (NICE) provide guidance for women at higher risk of breast cancer. Bronchoalveolar carcinoma lung. (closed to accrual) 23. Location: 15 locations, This randomized, phase II trial studies how well fulvestrant or exemestane with or without ribociclib works in treating patients with hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer that has progressed after treatment with an aromatase inhibitor or cyclin-dependent kinase 4 / 6 inhibitor (recurrent), cannot be removed by surgery (unresectable), or has spread to other parts of the body (metastatic). Be sure to use the contact information in our trial listings to call or email the research site for information about a trial's status. Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomized trials. The National Institute for Health and Clinical Excellence (NICE) provide guidance for women at higher risk of breast cancer. Part of Springer Nature. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. TAILORx is one of the first trials to examine a methodology for personalizing cancer treatment. Palbociclib is a drug that may stop tumor cells from growing by blocking activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called cyclin dependent kinases 4 and 6 (CDK 4 / 6) which are known to promote tumor cell growth. Sentinel lymph node resection compared with conventional axillary lymph node dissection in clinically node negative patients with breast cancer: overall survival findings from the NSABP B-32 randomized phase 3 trial. Prevention of contralateral breast cancer … The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer. for the APHINITY Investigators. Giving fulvestrant or exemestane with ribociclib may be an effective treatment for patients with breast cancer. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. Location: 15 locations, This randomized phase II trial studies the side effects of capecitabine and how well it works when it is given dose-dense, fixed-dose as compared to standard dose in treating patients with breast cancer or gastrointestinal cancer that has spread from where it started to other places in the body or gastrointestinal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) Chordoma (closed to accrual 11 / 29 / 2018) 31. J Clin Oncol. Randomized data on chemoprevention • Prospective, double-blind, randomized trial • Involved 19,747 postmenopausal females and studied tamoxifen versus raloxifene in preventing breast cancer • The final analysis initiated after at least 327 incident invasive breast cancers were diagnosed: 163 and 168 cases of invasive breast cancer in tamoxifen and raloxifene treated groups • No differences were found for other invasive cancer … Stage IV Triple Negative Breast Cancer … Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. … Fisher B, et al. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09 / 19 / 2018) 29. Location: 47 locations, This study looks at the risks and benefits of active monitoring (AM) compared to surgery in the setting of a pragmatic prospective randomized trial for low risk DCIS. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12 / 19 / 2017) 24. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Many studies have shown that women who are overweight or obese when diagnosed with breast cancer appear to have a higher risk of cancer recurrence. evaluated the optimal sequencing of chemotherapy and are discussed. The study has randomized more than 10,200 women with this type of breast cancer at 1,182 sites in the … The TAILORx trial and a study by Esserman et al. We searched PubMed and oncology congress websites (American Society of Clinical Oncology, San Antonio Breast Cancer Symposium, European Society of Medical Oncology) between Jan 1, 2000, and Sept 1, 2015, to identify clinical trials of CDK4/6 inhibitors in combination with adjuvant endocrine therapy for patients with oestrogen-receptor-positive, HER2-negative early breast cancer… Location: 1372 locations, This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Each treatment cycle lasts 21 days. Squamous cell carcinoma variants of the genitourinary (GU) system 19. A 15-year meta-analysis conducted by the Early Breast Cancer Trialists’ Collaborative Group of long-term outcomes among 100,000 women treated in 123 randomized trials to evaluate polychemotherapy demonstrated a 10-year breast cancer … Location: 29 locations, The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer. This randomized phase III compares weight loss interventions in treating overweight and obese women with a higher risk for breast cancer that comes back (recurrence). This trial is being done to find out whether addition of a platinum agent after completion of surgery will provide a higher disease free survival benefit than capecitabine in treating patients with residual triple-negative breast cancer. At the moment they recommend that women at high or moderate risk of breast cance… Trials have looked at hormone therapies including: 1. tamoxifen 2. raloxifene 3. anastrozole (Arimidex) The results show that these drugs can lower the risk of breast cancer in women at high risk. 2002a;347(8):567–75. A recent trial (Lancet 2006) confirms that Herceptin offers benefit with early stage breast cancer patients too. Adjuvant chemotherapy substantially reduces the risk of breast cancer recurrences and death in early-stage breast cancer. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. 2014;32:3744–52. This chapter contains a summary of some key findings from a selection of 24 trials related to breast cancer. Patients will swallow tucatinib pills or placebo pills two times every day. N Engl J Med. Announcing data from a prospective, phase II trial, Accuray (NASDAQ:ARAY) says that women with low-risk breast cancer who were treated with its TomoTherapy (“TOMO”)® System … Monoclonal antibodies, such as avelumab, may help the immune system in detecting and fighting tumor cells. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. Regional nodal irradiation in early stage breast cancer. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) All trials on the list are supported by NCI. However, it is not yet known whether proton therapy is more effective than photon therapy in treating patients with non-metastatic breast cancer without causing heart damage. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual) 4. WEDNESDAY, Aug. 15, 2018 (HealthDay News) -- For women with advanced breast cancer who carry the BRCA1 and BRCA2 gene mutations, an experimental drug could improve survival, a new … The clinical trials on this list are for breast cancer. Although "advanced" breast cancer … Location: 15 locations, Complementary & Alternative Medicine (CAM), Coping with Your Feelings During Advanced Cancer, Late Effects of Childhood Cancer Treatment, Frederick National Laboratory for Cancer Research, Milestones in Cancer Research and Discovery, Tech Transfer & Small Business Partnerships, Step 1: Application Development & Submission, How to Work With Your Health Insurance Plan, Questions to Ask about Treatment Clinical Trials, Drugs Approved for Different Types of Cancer, Drugs Approved for Conditions Related to Cancer, Weight Loss Interventions in Treating Overweight and Obese Women with a Higher Risk for Breast Cancer Recurrence, Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial), Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel with or without Carboplatin in Treating Patients with Triple-Negative Breast Cancer, Lymph Node Dissection and Radiation Therapy in Treating Patients with Breast Cancer Previously Treated with Chemotherapy and Surgery, Nivolumab and Ipilimumab in Treating Patients with Rare Tumors, Testing Platinum-based Chemotherapy after Surgery in Triple-Negative Breast Cancers, Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer, Testing the Ability to Decrease Chemotherapy in Patients with HER2-Positive Breast Cancer Who Have No Remaining Cancer at Surgery after Limited Pre-operative Chemotherapy and HER2-Targeted Therapy, Testing the Drug Atezolizumab or Placebo with Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer, Regional Radiation Therapy with or without Whole Breast Irradiation in Treating Patients with Estrogen Receptor Positive, HER2 Negative Low Risk Breast Cancer Who Have Undergone Breast Conserving Surgery or Mastectomy, Radiation Therapy with or without Olaparib in Treating Patients with Inflammatory Breast Cancer, Proton Beam Radiation Therapy or Photon Beam Radiation Therapy in Treating Patients with Non-Metastatic Breast Cancer, A Radiotherapy Comparative Effectiveness (RadComp) Consortium Trial, Olaparib with or without Atezolizumab in Treating Patients with Locally Advanced Unresectable or Metastatic Non-HER2-Positive Breast Cancer, Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS, Fulvestrant with or without Palbociclib and Avelumab in Treating Patients with Hormone Receptor Positive, HER2 Negative Metastatic or Recurrent Breast Cancer That Cannot Be Removed by Surgery Previously Treated with CDK and Endocrine Therapy, Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer, Trastuzumab, Vinorelbine Tartrate, and Avelumab with or without Utomilumab in Treating Patients with HER2-Positive Metastatic Breast Cancer, Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors, A Study of Tucatinib vs. These trials for a greater understanding ) 42 the standard of care genitourinary ( summary of breast cancer trials ) system 19 studies! 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