Mechanicsville

Researchers are evaluating the safety and effects of the medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This type of breast cancer involves cancer cells that grow in response to hormones like estrogen and progesterone but have little or no HER2 protein. The study focuses on people whose breast cancer worsened after treatment with cyclin dependent kinase (CDK) 4/6 inhibitor therapy. The trial is a phase 3, open-label, randomized study comparing PF-07248144 plus fulvestrant to other therapies chosen by doctors. Participants will receive either PF-07248144 tablets daily at home in 28-day cycles combined with fulvestrant injections at the clinic, or the usual treatment of everolimus tablets with endocrine therapy (either exemestane or fulvestrant). The study doctor will help decide the hormone therapy before starting treatment. The trial compares the experiences of those taking PF-07248144 plus fulvestrant with those receiving standard treatments to assess safety and effectiveness. During the study, researchers will monitor participants for disease progression or death, using blinded independent central review based on standard tumor response criteria. The main outcome measure is progression-free survival for up to about 2 years from randomization. Regular assessments, including clinical visits for injections and evaluations, will help track treatment effects and safety throughout the study.

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 goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

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 the Cost Communication and Financial Navigation (CostCOM) program to see how it affects cancer patients' ability to stick to their care plans and manage financial stress caused by high out-of-pocket medical costs. Financial hardship from cancer treatment can cause delays or stops in care and lower quality of life. This study compares usual care with CostCOM, which offers financial counseling, education, and resource connections to reduce financial barriers and ease financial burden. Patients with newly diagnosed solid cancers are randomly assigned to one of two groups. One group receives a brochure about financial navigation services, while the other group receives the usual financial care plus CostCOM counseling sessions lasting about one hour, given within 30 days after enrollment and then again at 3, 6, and 12 months. Non-patient participants involved in the study complete surveys and participate in in-depth interviews 15 to 39 months after the first patient enrollment. Participants are monitored for 12 months after completing the intervention. Researchers collect patient-reported information on care adherence affected by costs, financial hardship, worry about finances, quality of life, and satisfaction with care. They also assess patient and provider experiences with the CostCOM program, the accuracy of cost estimates communicated, and neighborhood characteristics. The study aims to understand how CostCOM impacts patients over time and their use of financial navigation resources.

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 two digital mindfulness meditation programs to support mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their main cancer treatments at least six months ago. The study aims to compare a live, instructor-led online program to a self-paced app-based program and also to explore factors that might influence how well these interventions work, including psychological distress levels and social factors like race and education. Participants will be assigned to one of three groups: a live online Mindful Awareness Practices (MAPs) program delivered over Zoom, a self-paced MAPs digital app, or a meditation-only control group. The live online program includes guided meditations, exercises to manage pain and emotions, and cultivating kindness, with daily home practice increasing from 5 to 20 minutes. The app program unlocks lessons sequentially as participants progress. Meditation use will be tracked across all groups to measure engagement. During the study, participants will report depressive symptoms two weeks after completing the intervention. Researchers will also collect information on emotion regulation strategies and social determinants of health, and monitor how much participants practice mindfulness to understand the programs' effects. The total intervention lasts six weeks, and participants must be able to use a digital device and communicate in English or Spanish. Safety and participation are closely monitored throughout the study.

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.