Milford

This research aims to collect detailed and standardized data from adult patients receiving routine cancer care at participating oncology centers. The study is observational and focuses on gathering information about patients, their treatments, and outcomes to support research and development in oncology. Patient surveys are also part of the data collection process to enrich the information gathered. Since this is an observational registry, there are no specific treatments or interventions provided by the study. Instead, it collects data on standard care treatments administered at the participating centers. The registry includes baseline patient information, treatment patterns, safety data, and treatment effectiveness over time. Participants will provide informed consent and contribute data through regular surveys and medical records. Researchers will monitor treatment effectiveness by tracking the time until treatment discontinuation. The study collects and analyzes data continuously, aiming to facilitate more patient involvement in clinical trials and improve cancer care research. Eligible adults may participate for as long as they continue routine care at the centers.

Researchers are evaluating patients with advanced or metastatic non-small cell lung cancer (NSCLC) to create control arms using current and future treatment information. This prospective study aims to generate precise external controls for patients receiving therapies recommended by the National Comprehensive Cancer Network (NCCN). The focus is on patients treated in second or third line with NCCN-approved systemic therapies. Participants must have pathologically confirmed NSCLC and an Eastern Cooperative Oncology Group (ECOG) performance status greater than 1, indicating they are fit for further systemic therapy. Eligible patients are those starting or within 14 days of starting second line therapy according to NCCN guidelines. The study monitors patients over time to assess treatment responses and outcomes. During the study, researchers assess the objective response rate (ORR) by patient cohort from September 2025 to April 2029. Participants are followed closely with imaging and clinical evaluations to ensure compliance with study protocols. Safety and life expectancy of more than three months are considered to support ongoing participation and data collection.

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 Lung-MAP treatment trial testing combinations of targeted drugs—capmatinib, osimertinib, and ramucirumab—to treat patients with advanced non-small cell lung cancer (NSCLC) that has spread and shows EGFR and MET gene changes. Capmatinib and osimertinib are kinase inhibitors that block abnormal proteins signaling cancer growth, while ramucirumab is an antibody that may stop new blood vessel growth needed by tumors. Targeting these gene changes may help shrink or control the cancer. Patients are randomized into two groups: one group receives capmatinib and osimertinib orally along with ramucirumab intravenously, while the other group receives capmatinib and osimertinib orally without ramucirumab. Throughout the study, participants undergo CT or MRI scans and provide blood samples. The treatments are given according to the assigned group to compare their effects and safety. During the trial, participants are closely monitored with imaging and blood tests to assess cancer progression and treatment side effects. The main measure is progression-free survival, tracking time until cancer worsens or death, over up to 3 years. Researchers also evaluate response rates, overall survival, toxicity, and collect tissue and blood samples to study tumor DNA. Participants' health status and laboratory values are regularly checked to ensure safety and effectiveness of the treatments.

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 a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are creating a prospective cohort of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has common EGFR mutations. The study focuses on patients diagnosed on or after January 1st, 2024, and aims to collect standardized clinical data at key points: before treatment begins, during treatment, and when treatment ends. About 30% of patients who join before starting osimertinib therapy will have imaging done at regular intervals to monitor their condition. The study involves patients receiving first-line osimertinib treatment for their advanced NSCLC. Although specific interventions are not detailed, the study tracks progression-free survival from when treatment starts until the disease worsens or the patient passes away, with assessments continuing for up to 100 months. This long-term follow-up allows researchers to observe how the cancer progresses in a real-world setting under this treatment. Participants will undergo standardized data collection including imaging and clinical evaluations at baseline, during treatment, and at therapy discontinuation. Researchers will monitor progression-free survival as the primary outcome. Eligibility is based on diagnosis details and treatment history, with exclusion for certain prior therapies and poor performance status. The study includes adults aged 18 years and older and will gather detailed information over an extended period to better understand treatment outcomes in this patient population.

Researchers are collecting real-world data on patients with advanced Epidermal Growth Factor Receptor (EGFR)-mutated Non-Small Cell Lung Cancer (NSCLC) who are treated outside of clinical trials. The study aims to better understand the safety and effectiveness of standard care treatments involving osimertinib alone or combined with chemotherapy. This observational study includes patients from both academic and community medical centers to reflect routine clinical practice. The study compares two treatment groups: one receiving osimertinib as a single oral daily dose, and another receiving osimertinib plus chemotherapy, with the chemotherapy regimen chosen by the treating physician. Treatment dosing and administration follow standard care guidelines or institutional protocols. The decision on which treatment a patient receives is made by their doctor and recorded when the patient joins the study. Participants will be followed as per their physician's usual care, including clinical and imaging assessments. Researchers will track progression-free survival, measuring the time from starting therapy until disease progression or death, for up to three years. The study plans to enroll up to 538 patients, with about 250 in each treatment group, to evaluate outcomes and monitor safety in a real-world setting.

Researchers are evaluating a phase III trial comparing shorter chemo-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study focuses on whether the anthracycline-free treatment combined with pembrolizumab is at least as effective as the standard anthracycline-containing regimen in preventing breast cancer events. The trial also examines various secondary outcomes including pathological response, survival rates, safety, tolerability, patient-reported quality of life measures, and translational objectives related to tumor immune markers. Participants are randomly assigned to one of two treatment groups. The first group receives paclitaxel, carboplatin, and pembrolizumab intravenously followed by doxorubicin, cyclophosphamide, and pembrolizumab before surgery. The second group receives docetaxel, carboplatin, and pembrolizumab intravenously before surgery. After surgery, patients in both groups may continue pembrolizumab treatment. Blood samples may be collected throughout the trial for additional analyses. During the study, participants undergo multiple assessments including imaging, blood tests, and physical exams before starting treatment. Patient-reported outcomes such as fatigue and physical function are collected through questionnaires. Follow-up visits occur every six months for two years, then annually up to five years to monitor breast cancer event-free survival and overall health. Safety and quality of life are continuously evaluated, and banking of physical specimens is performed for future research.

Researchers are evaluating a phase II Expanded Lung-MAP trial testing the use of tepotinib with or without ramucirumab for patients with advanced non-small cell lung cancer (NSCLC) that has spread to other parts of the body (stage IV) or has returned after improvement (recurrent). This study focuses on patients whose cancer has a mutated MET exon 14 skipping gene. Tepotinib is a kinase inhibitor that blocks the abnormal MET protein to slow tumor growth, while ramucirumab is an antibody that may prevent new blood vessels from forming, potentially inhibiting tumor growth. Participants are randomly assigned to one of two groups. In one group, patients receive ramucirumab through an IV infusion on day 1 of each 21-day cycle plus tepotinib tablets taken daily for 21 days. The other group receives only tepotinib tablets daily for 21 days per cycle. Treatment continues until the disease worsens or side effects become unacceptable. Optional lymphoscintigraphy scans may be done at screening and if peripheral edema (swelling) develops or worsens. Blood samples, CT or MRI scans, and urine samples are collected throughout the trial to monitor health and response. During the study, participants undergo various assessments including imaging scans, blood and urine tests, and monitoring for side effects. Follow-up visits occur every 12 weeks after treatment ends until disease progression, then every six months for two years, and a final check at three years from randomization. The main goal is to compare the response rate between the two treatment groups over up to three years. Researchers also track side effects, progression-free survival, overall survival, and duration of response to better understand the treatments' effects.