Clinical trials are research studies that involve people. All trials on the list are supported by NCI.. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Every year, oncology professionals and patient advocates gather in Chicago to hear the latest in cancer research at the American Society of Clinical Oncology’s annual meeting (ASCO). The American Society of Clinical Oncology (ASCO) will highlight the data during the plenary session of its annual meeting to occur virtually from May 29-31 (Abstract LBA2). Mammogram. 1-4 The UK START-B and Ontario trials established 15- and 16-fraction schedules as new standards of care delivered over 21-22 days. This is an important finding, since adding any kind of treatment can reduce a patient’s quality of life and functional status, in addition to the fact that many patients with early-stage breast cancer do not experience symptoms from their breast cancer. Each breast cancer‐selective trial enrolled a mean of 9.8 patients with MBC per trial (range 1‐22). At SABCS, BCRF investigator Dr. Elizabeth Mittendorf presented results on patient-reported outcomes from the trial, whereby patients assessed the impact of treatment on their ability to perform their normal roles within family or work environments, their physical, emotional, social, and cognitive function, and their overall health-related quality of life. The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) designed and led this trial, which was conducted in the NCI National Clinical Trials Network (NCTN) with funding from the National Cancer Institute, part of the National Institutes of Health. The trial is designed to compare the efficacy (as measured by progression-free survival) of the targeted agent sacituzumab govitecan (SG) versus chemotherapy. BeyondSpring Announces New Positive PROTECTIVE-2 Phase 3 Registrational Trial Results at the 2020 San Antonio Breast Cancer Symposium Published: Dec. 10, 2020 at 8:25 a.m. "Breast Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2020". Epub 2020 May 25. Dr. Sofia Merajver’s research has improved patients’ lives, including her own. New Clinical Trials for Stage IV Breast Cancer (September 2020) Ten new clinical trials for TNBC, HER2 positive, and other subtypes of metastatic (stage IV) breast cancer have been added to BreastCancerTrials.org (BCT) in the last month. Traditionally, it was thought that because metastases had occurred, local therapy would not provide any additional survival benefit beyond what systemic treatment could offer. A clinical trial is a research study that investigates new or emerging treatments for a disease and compares these treatments to established protocol to determine their effectiveness, safety or new usage. While the study was not designed to make statistical comparisons between the chemotherapy groups, an added benefit of immunotherapy was seen across all chemotherapy regimens, providing additional support for the use of anti-PD-L1 immunotherapy for the treatment of mTNBC. Black and Hispanic patients participate in clinical trials at lower rates than white patients nationally; lack of diversity in clinical trials prevents appropriate safety and efficacy testing of new treatments in these populations. While all patients benefited regardless of Trop-2 levels, those with the highest levels received the most benefit, nearly doubling their progression-free and overall survivals compared to chemotherapy. Based on these findings, pembrolizumab was granted accelerated FDA approval in combination with chemotherapy in PD-L1-positive mTNBC patients with no prior treatment. Further complicating matters, two randomised clinical trials published in the last five years had conflicting results. June 30, 2020. Your doctor will check both of your breasts and lymph nodes in your armpit, feeling for any lumps or other abnormalities. SG is an antibody-drug conjugate that targets Trop-2, a protein associated with poor prognosis in breast cancer and that has shown to be present at high levels on TNBC cells. A mammogram is an X-ray of the breast. "This result was a little surprising since one of the reasons for considering surgery and radiation is the idea that growth of the tumour will impair quality of life," said Dr. Khan. By BCRF | June 19, 2020. The "Breast Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2020" report has been added to ResearchAndMarkets.com's offering. 160O - Survival analysis of the randomized phase III GeparOcto trial comparing neoadjuvant chemotherapy (NACT) of iddEPC versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer, TNBC) (PM(Cb)) for patients (pts) with high-risk early breast cancer (BC) Login. 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This is the second FDA-approved checkpoint inhibitor for mTNBC. In April 2020, the FDA approved the drug sacituzumab govitecan-hziy (Trodelvy) to treat triple negative breast cancer that has spread to other parts of the body. "Trials like TAILORx, and now E2108, help ECOG-ACRIN, in a partnership with the National Cancer Institute and investigators all over the world, fulfil our mission to identify the best treatments for an individual patient and maximise quality of life. Immunotherapy was a hot topic at this year’s SABCS meeting, as it was at other scientific conferences in 2020, with researchers presenting key findings from several immunotherapy trials in TNBC at both ASCO and ESMO’s annual meetings. This year’s virtual meeting included a number of clinical trial presentations focused on these cancers. July 1, 2020 . Data from the long-awaited E2108 randomised phase three trial show that the survival experience of the two treatments was the same; local therapy did not improve overall survival. Amornrat Phuchom/iStock. FDA Approves Tukysa for Advanced HER2-positive Breast Cancer. Examples of systemic treatments are: chemotherapy to attack cells that grow quickly, targeted therapy that attacks specific proteins on cancer cells, hormonal therapy that either blocks or decreases the level of the body's natural hormones, which sometimes act to promote cancer growth, and, immunotherapy to stimulate the patient's immune system to attack the cancer. The other 15 breast cancer‐selective trials or cohorts had enrollment restricted only to breast cancer or a particular breast cancer subtype. We searched for primary research and reviews published in English between Jan 1, 1980, and April 22, 2020. Overall survival analysis, however, is ongoing, along with biomarker analysis to identify patients most likely to benefit from ipatasertib therapy. Data on overall survival are expected to be reported in 2021. We found 13 randomised studies testing adjuvant breast hypofractionated radiotherapy regimens against standard fractionation ranging in … In discussing the results, Dr. Rugo stressed that patients who had a longer disease-free interval before a metastatic diagnosis, as well as those who had not previously been treated with chemotherapy, tended to respond better overall. The clinical trials on this list are for breast cancer. Breast exam. Here, we highlight developments from notable TNBC trials. Their response to treatment was assessed at the time of surgery. The results show that the survival experience of the two groups was identical (half of them alive after 4.5 years). Clinical trials are research studies in which people agree to try new therapies (under careful supervision) in order to help doctors identify the best treatments with the fewest side effects. Breast Cancer Diagnostic Tests are used for detection of cancer based on the detection and measurement of cancer-specific biomarker/antibody/antigen present in … "When combined with the results of an earlier trial in Mumbai, India (Badwe et al, Lancet Oncol 2015), these results tip the scales against the possibility that local therapy to the breast tumour will help women live longer," said Dr. Khan. Visit Breast Cancer News's profile on Pinterest. ASCENT is an open-label randomized phase III study in patients with mTNBC that has progressed on at least two chemotherapies. 2020 Sep;31(9):1223-1230. doi: 10.1016/j.annonc.2020.05.012. The Food and Drug Administration (FDA) recently greenlighted a breast cancer vaccine technology developed at Cleveland Clinic, which allows clinical trials for the vaccine to move forward.. At SABCS, BCRF investigator Dr. Hope Rugo presented results from a subgroup analysis looking at the benefit of pembro in each chemotherapy group (nab-paclitaxel, paclitaxel, and gemcitabine/carboplatin). Read more of BCRF's SABCS 2020 coverage here. Check it out for all your SABCS news. Science News . Lines of Therapy: New Drugs May Change MBC Treatment . CLEVELAND, Ohio — The U.S. Food and Drug Administration on Monday cleared the way for human clinical trials to begin on a promising breast cancer vaccine, invented and … These studies help improve the overall standard of care. Several studies suggested that removal of the tumour in the breast with surgery would be beneficial. Dr. Mittendorf reported that patients receiving checkpoint inhibitor therapy did not experience additional burden on quality of life and functionality compared to those receiving chemotherapy alone. Treatment optimization–balancing … Breast Cancer Research and Treatment, 2020; DOI: 10.1007/s10549-020-05787-z; Cite This Page: MLA; APA; Chicago ; University of Illinois at Chicago. Tests and procedures used to diagnose breast cancer include: 1. IMpassion031 builds on the IMpassion130 study, which led to FDA approval of atezolizumab plus nab-paclitaxel for metastatic TNBC (mTNBC). We searched PubMed on April 22, 2020, using the search terms “breast cancer”, “adjuvant radiotherapy”, “hypofractionation”, and “randomised clinical trials”. Access the SABCS Virtual Site here. Research News. Clinical trials … Breast Cancer Trials Website Login. AKT acts as a primary regulator of this potent growth-promoting pathway and is the target of ipatasertib, an orally administered AKT inhibitor. It found that there was no quality of life advantage in the group of women who received local therapy to the breast tumour. 14/12/2020. Checkpoint inhibitors work by blocking the immune suppression action of the PD-1/PD-L1 pathway, which is shown to be activated in immune cells in the microenvironment of some breast cancers allowing tumors to avoid detection by the immune system. With your continued support, we can make every U.S. breast cancer trial available on our clinical trial search platform and bring you the most relevant and trusted news and... Read more. IPATunity 130 is a double-blind, placebo-controlled, randomized phase III study testing the combination of the targeted agent ipatasertib with paclitaxel in patients with locally advanced or mTNBC that harbor mutations in PIK3CA/AKT1/PTEN pathway. At the 2020 ESMO meeting, researchers reported a 16 percent increase in pathological complete response (no invasive cancer at time of surgery) in patients receiving the checkpoint inhibitor therapy plus chemotherapy compared to those who received the placebo. Tags: ASCO. IMpassion031 is a phase III trial in patients with early-stage TNBC testing the safety and effectiveness of the checkpoint inhibitor atezolizumab used in tandem with standard chemotherapy prior to surgery (called neoadjuvant therapy). Here, we conducted the FUTURE trial (ClinicalT … The San Antonio Breast Cancer Symposium 2020 (SABCS 2020) is one of the most important breast cancer conferences in the world and brings together the world’s leading breast cancer researchers, including those from Breast Cancer Trials. Anastrozole and Tamoxifen Both Prevent Breast Cancer for Postmenopausal Women 09/12/2020 Long-term follow-up of the IBIS-II DCIS clinical trial has found that Anastrozole and Tamoxifen are both effective in preventing breast cancer and DCIS, providing more treatment options for postmenopausal women with an early form of breast cancer. Breast Cancer Diagnostic Testing Device Pipeline Assessment Report 2020: Stage of Development, Territory, Regulatory Path, Estimated Approval Date, Ongoing Clinical Trials - ResearchAndMarkets.com Of those whose disease responded to initial systemic therapy, or stayed stable, 256 women agreed to be randomised to either continue with systemic therapy or to receive surgery and radiation (local therapy) and then continue on with systemic treatment. Our previous study classified TNBCs into four subtypes with putative therapeutic targets. Username. Given the promising but limited results of checkpoint inhibitor (anti-PD-1/PD-L1) therapy plus chemotherapy in advanced TNBC, several trials are underway to determine whether adding immunotherapy earlier in the course of disease can improve outcomes without reducing quality of life in patients with early-stage disease. Earlier reported results showed a clinically meaningful improvement in progression-free survival (9.7 months vs. 5.6 months) with the addition of pembro compared to placebo in patients whose tumors had high levels of the PD-L1 protein. Investigators presented key findings for this aggressive form of breast cancer, General Office: 646-497-2600 | Toll Free: 1-866-346-3228, Updates from Triple-Negative Breast Cancer Trials Featured at SABCS. Further complicating matters, two randomised clinical trials published in the last five years had conflicting results. Starting about 20 years ago, this approach was questioned based on the idea that the primary tumour could be a source of re-seeding of cancer outside the breast. Some breast cancer trials have temporarily stopped enrolling new patients. FDA Approves Phesgo as Injection Treatment for HER2-positive Breast Cancers. SABCS has a new New site www.sabcsmeetingnews.org. BioNews Services, … In discussing the results and the future of targeted inhibition of the AKT pathway, given inconsistent clinical trial results, Dr. Rebecca Dent of Singapore National Cancer Center noted that there is still much we don’t understand about the effects of targeting AKT, particularly in TNBC, a highly heterogeneous disease with a variety of molecular drivers. At this year’s virtual San Antonio Breast Cancer Symposium (SABCS)—the world’s largest scientific conference dedicated to breast cancer—investigators reported a number of key findings from trials testing immunotherapies and targeted agents for triple-negative breast cancer (TNBC), an aggressive form of the disease. The 2020 San Antonio Breast Cancer Symposium Summary. Password. "Instead, we find that the adverse effects of surgery and radiation appear to balance out the gains in quality of life that were achieved with better control of the primary tumour.". Keynote-355 is a randomized, double-blind, phase III study testing the combination of another checkpoint inhibitor called pembrolizumab (pembro) with chemotherapy, versus a placebo plus chemotherapy, in patients with previously untreated, locally recurrent inoperable or metastatic TNBC. ET Comments Remember My Login. We are very pleased to announce that the San Antonio Breast Cancer Symposium will take place in 2020. Up to now, women who present with a new diagnosis of breast cancer that is already in an advanced stage (stage IV) face an unanswered question about whether surgery and radiation to the tumour in the breast (local therapy) will prolong survival compared to the traditional treatment of systemic treatment alone. In response to COVID-19, some breast cancer trials have temporarily stopped enrolling new patients. Mammograms are commonly used to screen for breast cancer. The drug works by recognizing and attaching to Trop-2 on cancer cells and then releasing a toxic drug that kills the cell. Research News. Improved tolerability of neratinib in patients with HER2-positive early-stage breast cancer: the CONTROL trial Ann Oncol. Confirming findings from the phase II study, patients receiving SG had better progression-free survival FS) and overall survival. Based on results from the phase II study published in The New England Journal of Medicine, SG was granted accelerated FDA approval in 2020 for advanced, refractory TNBC under the trade name Trodelvy©. "Based on the results of our study, women who present with a new diagnosis of breast cancer already in stage IV should not be offered surgery and radiation for the primary breast tumour with the expectation of a survival benefit," said lead investigator Seema A Khan, MD (Northwestern University). It accounts for 10 to 15 percent of breast cancers, including many driven by BRCA1/2 gene mutations, and it unfortunately lacks many targeted treatments. IMpassion031 involved 333 newly diagnosed patients with TNBC who were randomly assigned to receive either atezolizumab plus chemotherapy (nab-paclitaxel, doxorubicin, or cyclophosphamide) or the same chemotherapy agents plus a placebo prior to undergoing breast cancer surgery. Testing checkpoint inhibitors with chemotherapy for TNBC. Each traditional phase I trial enrolled a mean of 1.6 patients with MBC per trial … FDA’s New ‘Project Patient Voice’ to Share Symptoms Data From Cancer Trials. The subgroup analysis presented by Dr. Sara Hurvitz of The University of California, Los Angeles included 468 patients (265 receiving SG and 233 receiving chemotherapy) and compared the efficacy of SG to chemotherapy based on the tumor expression of Trop-2 and germline (inherited) BRCA1/BRCA2 mutation status of the patient. Conference Summaries. However, these studies were flawed because women receiving surgery tended to be younger, healthier, and have less severe disease. 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