Hastings

Researchers are evaluating the efficacy and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered via a multidose dry powder inhaler with an electronic module in people aged 12 years and older who have asthma. The study is designed as a randomized, double-blind, placebo-controlled trial and aims to assess lung function improvements, safety, tolerability, and drug behavior in the body over a four-week period. Secondary goals include evaluating the combination inhaler administered four times daily and understanding the pharmacokinetics of the inhaler components after a single dose. Participants will be randomly assigned to one of four groups receiving either the combination inhaler FpABS, fluticasone propionate inhaler Fp, albuterol sulfate inhaler ABS, or a placebo inhaler, all with integrated electronic modules. Treatments are inhalation powders administered via dry powder inhalers. The study lasts about 10 weeks per participant, including the treatment period of four weeks and follow-up assessments. The trial includes a prescreening visit as an option before formal enrollment. During the study, participants will have their lung function measured through forced expiratory volume in one second FEV1, asthma control assessed by questionnaires ACQ-6 and ACT, and blood samples taken to analyze drug levels. Safety is monitored by tracking adverse events and tolerability over the treatment period. The main outcomes focus on changes in lung function at baseline and after four weeks of treatment. Participants are expected to attend multiple visits for these assessments throughout the study duration.

Researchers are studying if MK-5684, a medicine that blocks steroid hormone production, can treat breast cancer, ovarian cancer, and endometrial cancer. The study compares MK-5684 with standard treatments to see if it helps people live longer without their cancer growing or spreading. This is a Phase 2 trial focusing on specific solid tumors including hormone receptor positive breast cancer, high-grade ovarian cancer, and low-grade endometrial cancer. Participants with breast cancer will receive 5 mg of MK-5684 twice daily along with fludrocortisone and dexamethasone tablets adjusted as needed. Breast cancer participants may also receive endocrine therapy such as fulvestrant or exemestane. Those with ovarian cancer will be observed without treatment during the study. Participants with endometrial cancer will receive physician-selected treatments including megestrol acetate, tamoxifen, or letrozole. Treatments continue until specific stopping conditions are met. During the study, participants will be monitored for cancer progression and survival up to about two years. Researchers will assess how long participants live without their cancer worsening and overall survival. They will also track response to treatment, clinical benefit, and adverse events. This includes regular clinic visits, assessments, and safety monitoring to understand how well MK-5684 works compared to other treatments. The trial is expected to last until late 2027.

Researchers are evaluating whether adding adjuvant chemotherapy ACT to ovarian function suppression OFS plus endocrine therapy ET improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigators discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients health and quality of life.

Researchers are creating and maintaining the Integrated Cancer Repository for Cancer Research iCaRe2, a multi-institutional resource gathering detailed, ongoing data and biospecimens from adult cancer patients, people at high risk, and healthy controls. This platform covers a wide geographic area, including many small and rural hospitals, to support comprehensive studies on cancer risks, development, progression, and to aid in designing new prevention, screening, early detection, and personalized treatment strategies. The iCaRe2 collects multi-dimensional cancer-related data and biospecimens such as tumor specimens, DNA, serum, urine, and plasma from various cancer registries covering numerous cancer types, including pancreatic, breast, thyroid, lung, gastrointestinal, genitourinary, central nervous system, blood cancers, skin cancers, and more. It uses a flexible confederation model allowing multiple centers to participate based on their expertise and resources. The platform is web-based, HIPAA compliant, and supports secure data collection, validation, standard vocabularies, and reporting. Participants provide informed consent and may include those diagnosed with cancer, at risk for cancer, or healthy controls. Data collection includes longitudinal monitoring and banking of biological materials for future study. Researchers measure the development and implementation of this web-based cancer registry and the procurement of biological materials over many years. Participants involvement includes data sharing and biospecimen donation, supporting studies in cancer biology, genetics, epidemiology, early detection, and patient care, with ongoing follow-up up to many years.

Researchers are evaluating whether observation alone is as effective as continuing treatment with pembrolizumab in preventing cancer recurrence in patients with early-stage triple-negative breast cancer TNBC who achieved a complete response after receiving chemotherapy combined with pembrolizumab before surgery. This phase III trial aims to compare these approaches in terms of recurrence-free survival, quality of life, and overall value of care. The study also examines side effects, survival rates, and financial impacts associated with the treatments. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab treatment intravenously every 3 or 6 weeks for 27 weeks, while the other group undergoes observation without additional treatment during this period. Both groups will have tumor biopsies and blood samples collected, along with imaging tests like mammography, breast ultrasound, or MRI during follow-up. Throughout the study, participants will be monitored for cancer recurrence, survival, adverse events, and quality of life using questionnaires and assessments. Blood and tumor samples will help track biological markers. The primary outcome is recurrence-free survival over up to 10 years. Secondary outcomes include adverse event rates, overall survival, and local recurrence. Additional evaluations cover financial costs, work productivity, and patient-reported side effects. The total participation may involve long-term follow-up and several assessments over approximately 27 weeks and beyond.

Researchers are evaluating how well serum tumor marker directed disease monitoring STMDDM works compared to usual care in patients with hormone receptor positive, HER2-negative metastatic breast cancer. This trial aims to see if monitoring with serum tumor markers can provide similar overall survival outcomes to the standard approach, which involves regular imaging scans. The study also looks at healthcare costs, patient anxiety, and quality of life related to these monitoring methods. Participants are randomly assigned to one of two groups. In the usual care group, patients receive imaging studies at least every 12 weeks and may have serum tumor marker tests as determined by their doctor. In the STMDDM group, patients have blood tests for specific tumor markers every 4 to 8 weeks, and imaging scans are only done if these markers indicate a possible progression of disease. Both groups continue their monitoring for up to 312 weeks unless the disease progresses. During the study, participants undergo regular assessments including blood tests for tumor markers, imaging scans as needed, and questionnaires about anxiety and quality of life. Researchers track overall survival for up to 312 weeks and compare healthcare costs and patient-reported outcomes for up to 48 to 102 weeks. The study also collects data on how often and by what methods disease monitoring is performed, along with patient and physician preferences related to monitoring.

Researchers are studying the safety, effectiveness, and how the body processes pumitamig BNT327 combined with chemotherapy and other investigational treatments in people with first-line non-small cell lung cancer NSCLC. This Phase 23, multisite, randomized, open-label trial includes two substudies based on NSCLC subtypes, reflecting differences in standard chemotherapy choices. The study is sponsored by BioNTech SE and aims to better understand treatment options for this condition. Participants in each substudy enter a Phase 2 part where they are randomly assigned to one of two doses of pumitamig plus chemotherapy. Afterward, they may move to a Phase 3 part, where an independent committee continuously reviews safety data and tumor scan results. Study treatments include pumitamig, pembrolizumab, carboplatin, pemetrexed, and paclitaxel, all given via intravenous infusion. The study duration for each participant can be up to 64 months. During the trial, participants will undergo regular tumor assessments, safety monitoring for side effects, and quality-of-life evaluations using questionnaires. Researchers will track adverse events, treatment responses, progression-free survival, overall survival, and symptom changes up to approximately 5 years. Participants will have scheduled follow-ups for up to 90 days after treatment to monitor safety and treatment impact.

This research aims to evaluate if the experimental combination of sacituzumab govitecan-hziy SG and pembrolizumab given after surgery is effective and safe compared to the treatment of physicians choice TPC in adults with triple negative breast cancer TNBC who still have invasive disease after surgery and pre-surgical treatment. The study focuses on participants whose cancer remains after neoadjuvant therapy and surgery, exploring new options to improve outcomes in this challenging condition. Participants are randomly assigned to one of two treatment groups. One group receives sacituzumab govitecan-hziy intravenously at 10 mgkg on Days 1 and 8 of a 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each cycle, for up to 8 cycles. The other group receives the treatment of physicians choice, which includes pembrolizumab alone or pembrolizumab plus oral capecitabine for 8 cycles. Treatment continues until 8 cycles are completed, disease recurrence, unacceptable side effects, physician decision, withdrawal, or death. During the study, participants undergo regular assessments to measure invasive disease-free survival for up to 60 months as the primary outcome. Secondary outcomes include overall survival up to 96 months, distant disease-free survival, recurrence-free survival, and monitoring of treatment side effects and laboratory abnormalities. Researchers also evaluate quality of life using questionnaires. The total participation includes treatment cycles followed by long-term monitoring to assess effectiveness and safety over several years.