Harbor Springs

Researchers are evaluating if adding a special device called the TheraBionic P1, which uses amplitude-modulated radiofrequency electromagnetic fields, can impact the treatment response in women with early-stage, operable breast cancer that is hormone receptor positive and HER2-negative. This pilot study focuses on patients scheduled for surgery and aims to understand how this device affects the cancer before removal. Participants will use the TheraBionic P1 device by self-administering three 60-minute treatments each day—morning, midday, and evening—continuously for about two weeks before their planned surgery to remove the tumor. The device delivers specific electromagnetic fields targeting the cancer during this pre-surgical period. During the study, participants will be closely monitored, and their pathological response to the treatment will be assessed at the time of surgery, approximately two weeks after starting the device therapy. Researchers will review tissue samples and track safety measures while ensuring participants follow the treatment and study protocols. This involvement lasts from treatment initiation through surgery and includes follow-up monitoring for adherence and safety.

Researchers are evaluating if adding amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) to the drug Fruquintinib can improve survival and be safe for patients with metastatic colorectal cancer that no longer responds to standard treatments. This phase 2 study focuses on people with confirmed metastatic colorectal adenocarcinoma who have previously received specific chemotherapy and targeted therapies but whose cancer has progressed or who cannot tolerate those treatments. Participants receive Fruquintinib, a drug that targets certain blood vessel receptors involved in cancer growth, combined with the TheraBionic P1 device, which delivers AM RF EMF. The study tests this combination's effects on survival and tolerance. Treatment monitoring includes regular imaging scans such as CT, MRI, or PET to evaluate disease status. During the study, participants are closely monitored for overall survival up to five years after treatment ends or until death. Researchers assess safety, organ function, and cancer progression through scans and clinical evaluations. Participants must be able to take oral medication and use the device, and they are followed according to the study protocol for the entire duration of the trial.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating comprehensive genomic analysis in tissue samples from patients with recurrent or stage IV non-small cell lung cancer. This analysis aims to identify specific gene mutations in the cancer's DNA, which may help doctors tailor treatments to target these mutations more precisely. The study seeks to determine how often therapy can be started based on these genomic test results and to understand the outcomes for patients who receive such targeted therapy. Patients provide tumor tissue samples for genomic analysis using techniques like mass spectrometry, polymerase chain reaction (PCR), and microarray. Those whose genomic results indicate suitable targets may begin therapy tailored to their tumor's specific mutations. The study involves collecting and analyzing existing tumor samples or performing new biopsies if needed. During the study, patients undergo laboratory tests and tissue collection, followed by therapy initiation when appropriate. After treatment, patients are monitored every 3 months for 2 years, then every 6 months for 3 years, and annually thereafter to track progression-free survival and response to therapy. The main outcome measured is the proportion of patients who start treatment based on genomic analysis within 21 days. Safety and long-term outcomes are also followed.

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 evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

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 safety and effectiveness of a combination treatment for patients with metastatic pancreatic adenocarcinoma. This Phase 2 study investigates the use of gemcitabine, nab-paclitaxel, and the TheraBionic P1 device, which delivers amplitude-modulated radiofrequency electromagnetic fields, to see if this approach can help control the disease. The treatment involves giving patients nab-paclitaxel as a 30-40 minute infusion weekly on days 1, 8, and 15 or on days 1 and 15. Following this, gemcitabine is administered over 30 minutes on the same schedule. In addition, patients use the TheraBionic P1 device, which applies low-level radio waves through an antenna placed in the mouth three times daily for one hour each time. Participants will be closely monitored throughout the study. This includes imaging scans like CT, MRI, or PET to measure tumor response, laboratory tests to check blood counts and organ function, and assessments of overall health and side effects. The main outcome measured is the progression-free survival rate at six months. Patients are followed to assess safety, treatment effects, and to understand how well they tolerate the combination therapy.

Researchers are evaluating two chemotherapy treatments, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for advanced, unresectable, or metastatic HER2 negative adenocarcinoma of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine whether adding irinotecan to the usual FOLFOX regimen improves overall survival and other outcomes such as progression-free survival, response rates, and treatment tolerability. The study also explores biomarkers like PD-L1 combined positive score and cell free DNA to understand treatment effects better. Participants are randomly assigned to one of two treatment groups. One group receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with nivolumab as needed, while the other group receives fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with nivolumab as needed. All drugs are given intravenously. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional testing. During the study, participants are closely monitored for overall survival for up to two years after randomization. Researchers assess safety, side effects, and patient-reported outcomes to evaluate treatment tolerability. The trial also tracks progression of disease and response to therapy using imaging and other clinical evaluations. Participation includes regular imaging, blood collection, and completing questionnaires to help understand the impact of these treatments.

This research aims to compare the effects of usual care including regional radiation therapy with no regional radiation therapy in women with low-risk breast cancer. It focuses on patients with node positive breast cancer or T3N0 disease who typically receive endocrine therapy and possibly chemotherapy to prevent cancer recurrence. The study examines whether skipping regional radiotherapy still effectively prevents breast cancer from returning, potentially reducing unnecessary treatment and side effects. Participants will be divided into two groups: one receiving radiotherapy to the breast/chest area and surrounding lymph nodes, and the other receiving no regional radiotherapy. The study evaluates standard treatments, ensuring radiation therapy starts within specific time frames after surgery or chemotherapy. Treatments include breast-conserving surgery or mastectomy, along with endocrine therapy planned for at least five years. During the study, researchers will monitor breast cancer recurrence-free intervals over approximately 9.5 years. Participants will undergo regular assessments to track cancer status, side effects, and overall health. The study includes quality of life questionnaires for some patients and requires ongoing follow-up to document treatment effects, adverse events, and long-term outcomes.