Kennebunk

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.

Researchers are investigating targeted therapies approved by the Food and Drug Administration FDA for patients with advanced cancers that have specific genetic changes. This study, called the Targeted Agent and Profiling Utilization Registry TAPUR Study, aims to understand how safely and effectively these targeted drugs work when prescribed in real-world settings for cancers with actionable genomic variants. The study also collects data on molecular testing choices and helps generate ideas for future clinical trials. Participants receive one of several FDA-approved targeted anticancer drugs, chosen based on specific genetic features of their tumors. These drugs include palbociclib, sunitinib, temsirolimus, trastuzumab with pertuzumab, vemurafenib with cobimetinib, regorafenib, olaparib, nivolumab with ipilimumab, abemaciclib, talazoparib, atezolizumab with talazoparib, tucatinib with trastuzumab, futibatinib, dabrafenib with trametinib, and fam-trastuzumab deruxtecan-nxki. Each treatment follows the approved dosing schedule and duration. Different genetic alterations qualify patients for different drugs, and the study covers a wide range of tumor types, including advanced solid tumors, multiple myeloma, and non-Hodgkin lymphoma. During the study, participants undergo regular assessments including physical exams and imaging tests to measure tumor response using standard criteria. The main outcome measured is the percentage of patients with tumor shrinkage or stable disease after 16 weeks of treatment. Researchers also monitor overall survival for up to three years. Safety and organ function are closely tracked through laboratory tests. Participants must provide informed consent and meet specific eligibility criteria, including measurable disease and acceptable organ function. The study does not use random assignment, and results are shared publicly as they become available and at study completion.