Highlands Ranch

Researchers are working to develop a better standard of care for people who have cancer or might be at risk of developing it. This study is not testing any treatments but focuses on collecting and studying blood, tissue, and other biological samples from patients. The goal is to use this information, along with medical records and survey data, to support new clinical trials, technology development, and personalized medicine for cancer patients. Participants provide blood, tissue, and other biological samples through procedures. They also complete surveys about their quality of life, and researchers review their medical charts. The study collects a broad range of data to understand cancer better and to help advance future care options. During the study, participants may be involved for up to 20 years. Researchers will gather and analyze biological samples, survey responses, and medical records over this time. The main focus is on improving cancer care standards, with ongoing monitoring and data collection to facilitate long-term research and personalized treatment strategies.

Researchers are evaluating a new decision aid for women newly diagnosed with early-stage breast cancer. This study focuses on understanding how practical and acceptable this tool is for patients making surgical treatment choices between lumpectomy and mastectomy. Feedback from patients and the process of using the decision aid will help improve it and guide plans for a larger trial comparing it to standard education materials. Participants will receive either the novel decision aid, which helps patients consider risks, benefits, and personal values in treatment decisions, or a standard electronic educational pamphlet about surgical options. The decision aid includes data from previous patients' quality of life after breast cancer surgery. The study uses several tools to assess the decision aid, including patient-reported outcomes, decision aid evaluation measures, health literacy tests, distress screenings, online surveys, and interviews. Women in the study will be monitored over one year to see how well they receive the decision aid and if it is feasible to use. Researchers will gather data through questionnaires, interviews, and assessments to understand patient experiences and decision-making quality. This includes tracking patient feedback and distress levels, with the goal of improving shared decision-making support for breast cancer surgery choices.

Researchers are evaluating multiple immunotherapy-based treatment combinations in an open-label Phase Ib/II study involving participants with advanced liver cancers, including locally advanced or metastatic hepatocellular carcinoma (HCC) who have not previously received systemic therapy. This study is designed as a randomized umbrella trial that can add or close treatment arms based on activity or toxicity, and may include additional groups with other types of advanced primary liver cancer. Participants receive various immunotherapy drugs such as Atezolizumab, Bevacizumab, Tiragolumab, Tocilizumab, TPST-1120, Tobemstomig, ADG126, IO-108, and NKT2152, administered intravenously or by mouth in cycles ranging from 21 to 28 days. Initially, participants are randomly assigned to treatment arms in Stage 1. Those who lose clinical benefit or experience unacceptable toxicity may move to Stage 2 to receive different treatment combinations, which are added through protocol amendments. During the study, participants are monitored from randomization until disease progression or loss of clinical benefit, which could last approximately 7 to 9 years. Researchers assess objective response rate as the primary outcome. Participants undergo evaluations including tumor biopsies, biomarker testing, and hematologic and organ function tests. Safety and clinical benefit are continuously monitored, with tumor specimens collected if participants enter Stage 2. The study ensures ongoing assessment of treatment effects and participant health over an extended period.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Researchers are evaluating sacituzumab tirumotecan alone and combined with pembrolizumab compared to the treatment chosen by a physician for people with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer that cannot be removed by surgery or has spread to other parts of the body. This study focuses on participants whose cancer has progressed despite prior endocrine therapy, including treatment with a CDK4/6 inhibitor. The main goal is to see if these treatments improve progression-free survival, which means the length of time the cancer does not worsen, over up to approximately 38 months. Participants receive sacituzumab tirumotecan as an intravenous infusion, either alone or combined with intravenous pembrolizumab. The comparison group receives the treatment of physician's choice, which may include intravenous paclitaxel, nab-paclitaxel, liposomal doxorubicin, or oral capecitabine. The study is open-label and randomized, meaning participants are assigned to different treatment groups openly. Treatments are administered according to the study protocols, with ongoing monitoring during the treatment period. Throughout the study, participants are monitored regularly to assess their cancer status and overall health. This includes evaluations by blinded independent central review using RECIST 1.1 criteria to measure tumor progression. Researchers also assess safety, organ function, and performance status. The total participation time may last up to around 38 months to track progression-free survival and other outcomes. Careful monitoring helps ensure participant safety and collects data on treatment effectiveness and side effects.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

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.

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 trial to test the effect of combining pembrolizumab, an immunotherapy drug, with radiation therapy after chemotherapy in patients with muscle invasive bladder cancer. The goal is to see if this combination can prevent the need for surgery to remove the bladder. Standard care involves chemotherapy before surgery to shrink or eliminate the tumor. Pembrolizumab may help the immune system attack the cancer, while radiation therapy uses high-energy x-rays to kill cancer cells and shrink tumors. Participants receive photon beam radiation therapy once daily from Monday to Friday for up to 20 treatments. Pembrolizumab is given through an intravenous infusion on the first day of each 21-day cycle, continuing for up to 18 cycles or about one year, unless the disease progresses or side effects become unacceptable. Patients also undergo transurethral resection of bladder tumor (TURBT) before starting treatment. Imaging tests like CT, MRI, or PET scans, along with cystoscopy and sample collections of urine and blood, are performed throughout the study. During the study, researchers monitor participants’ health with scans, biopsies, and questionnaires about symptoms related to gastrointestinal, urinary, and sexual function. They measure bladder intact event-free survival within three years, local recurrence, metastasis-free survival, overall survival, and the rate of needing surgery to remove the bladder. After treatment, patients are followed every 26 weeks for two years and then annually up to five years. The study also collects samples for future research and tracks treatment side effects carefully.

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.