Edwards

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

The CHILL'D Study investigates treatments for adults aged 18 to 65 who are experiencing depressive symptoms or are healthy controls. It compares the effects of whole body heat exposure alone versus heat exposure followed by a cold water plunge to see how these approaches may impact mood and depression. The study includes both people with major depressive disorder and those without depression to better understand the treatments' effects. Participants are randomly assigned to one of two groups. One group receives a single session of whole body hyperthermia using the Clearlight Sauna Dome for up to 140 minutes. The second group receives the same heat treatment followed immediately by a cold water plunge in 55-degree Fahrenheit water lasting up to 10 minutes. This design allows comparison between heat treatment alone and heat plus cold therapy. During the study, participants complete assessments of their depressive symptoms at baseline, then again one week and two weeks after treatment. The main outcome measure is the Montgomery-Åsberg Depression Rating Scale (MADRS). Participants must attend all visits and complete questionnaires in English or Spanish. Safety is monitored by excluding those with certain medical risks or recent severe suicidal thoughts. The total study participation includes initial treatment and follow-up assessments over two weeks.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating a phase II trial to test the effect of combining pembrolizumab, an immunotherapy drug, with radiation therapy after chemotherapy in patients with muscle invasive bladder cancer. The goal is to see if this combination can prevent the need for surgery to remove the bladder. Standard care involves chemotherapy before surgery to shrink or eliminate the tumor. Pembrolizumab may help the immune system attack the cancer, while radiation therapy uses high-energy x-rays to kill cancer cells and shrink tumors. Participants receive photon beam radiation therapy once daily from Monday to Friday for up to 20 treatments. Pembrolizumab is given through an intravenous infusion on the first day of each 21-day cycle, continuing for up to 18 cycles or about one year, unless the disease progresses or side effects become unacceptable. Patients also undergo transurethral resection of bladder tumor (TURBT) before starting treatment. Imaging tests like CT, MRI, or PET scans, along with cystoscopy and sample collections of urine and blood, are performed throughout the study. During the study, researchers monitor participants’ health with scans, biopsies, and questionnaires about symptoms related to gastrointestinal, urinary, and sexual function. They measure bladder intact event-free survival within three years, local recurrence, metastasis-free survival, overall survival, and the rate of needing surgery to remove the bladder. After treatment, patients are followed every 26 weeks for two years and then annually up to five years. The study also collects samples for future research and tracks treatment side effects carefully.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are investigating whether adding the chemotherapy drug Docetaxel to the usual hormone treatments can better control metastatic castration sensitive prostate cancer (mCSPC) in patients who have a less than optimal PSA response after 6 to 12 months of androgen-targeting therapy. This phase III, open-label, randomized international trial compares the effectiveness of Docetaxel combined with standard Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitors (ARPI) versus ADT and ARPI alone. The study focuses on men with metastatic prostate adenocarcinoma who have a suboptimal PSA decline following initial hormone therapy. Participants receive standard ADT and an ARPI such as abiraterone, enzalutamide, apalutamide, or darolutamide, which are assigned before enrollment. At enrollment, patients are randomized to receive either the addition of Docetaxel chemotherapy or no chemotherapy alongside their hormone therapy. The goal is to assess whether this combination reduces cancer growth or spread compared to hormone therapy alone. Treatment begins within five working days after enrollment, with close monitoring throughout the study. Throughout the trial, participants undergo regular assessments including PSA measurements to monitor cancer activity and overall survival tracked at 39 months. Eligibility requires stable organ function, performance status, and recovery from prior treatment side effects. Patients are monitored for adverse events, safety, and treatment response. The study also ensures participants and their partners use contraception if of childbearing potential, and participants must be accessible for treatment and follow-up visits to document outcomes and safety data.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating the effects of a single 25 mg dose of synthetic psilocybin, given with psychological support, on adults aged 18 to 70 experiencing a major depressive episode lasting at least 60 days. The study aims to assess how different post-dosing interventions, including a non-invasive device called transcutaneous auricular Vagus Nerve Stimulation (taVNS), affect symptoms of depression, social behavior, and quality of life. This is a Phase 2 study designed to understand and optimize psilocybin's antidepressant effects using a set and setting therapeutic approach. All participants will receive psilocybin with preparatory sessions before dosing, two facilitators present during the dosing session, and integration sessions afterwards. After dosing, participants will be randomly assigned to one of three groups: active taVNS for 7 days with twice daily treatments, sham taVNS for 7 days with twice daily treatments, or no taVNS. Both active and sham taVNS sessions include guided reflection prompts and music from the dosing session to support participants. Participants will be involved in multiple assessments before and after the psilocybin dose, measuring depression severity, anxiety, well-being, social roles and activities, quality of life, suicidal thoughts, and any adverse events. The main outcomes include changes in depression rating scales, ability to participate in social roles, and quality of life scores measured from baseline to 8 weeks after dosing. Safety and treatment effects will be monitored throughout the study.

Researchers are evaluating the use of losartan, an FDA-approved drug that blocks transforming growth factor beta-1 (TGF-β1), to reduce radiation-induced fibrosis in the breast and lung of breast cancer patients. This phase II, randomized, double-blind, placebo-controlled study tests the hypothesis that losartan will decrease fibrosis, levels of TGF-β1, and cellular senescence or inflammation compared to placebo, potentially improving clinical outcomes for these patients. Participants will be randomly assigned to one of four groups based on their surgery type (breast conserving surgery or mastectomy) and will receive either 25 mg of losartan or a matching placebo capsule once daily. Treatment begins on the first day of radiation therapy and continues for one year after radiation ends. Radiation treatment will follow standard clinical procedures. The study is conducted at a single site, the Vail Health Shaw Cancer Center in Edwards, Colorado. During the study, participants will be assessed at baseline and at 3, 6, 12, and 18 months after radiation therapy for breast fibrosis, lung fibrosis, and related biomarkers, including cellular senescence and TGF-β1 levels. Follow-up includes evaluations of fibrosis, cosmetic outcomes, and any reoperations. Safety and treatment adherence will be monitored throughout the study and follow-up period.

Researchers are studying a treatment called Izalontamab Brengitecan compared to standard platinum-based chemotherapy for people with advanced urothelial cancer that has worsened after immunotherapy. This trial includes both Phase 2 and Phase 3 stages and focuses on patients whose disease progressed despite prior immune-based treatments. The goal is to evaluate how well these treatments control the cancer and how safe they are over time. Participants in this study will receive either Izalontamab Brengitecan or platinum-based chemotherapy drugs such as cisplatin, gemcitabine, or carboplatin. Each drug is given at specified doses on certain days, following the study plan. The Phase 2 portion aims to determine the best dose for further testing over about three months, while the Phase 3 portion will compare how long patients live without their cancer worsening and overall survival up to five years. Throughout the study, participants will have regular assessments to measure tumor size and monitor health status using standardized criteria and performance scales. Researchers will track progression-free and overall survival as main outcomes. The total follow-up may extend up to five years to observe long-term effects and safety of the treatments.