Rio Rancho

Researchers are evaluating new treatments for hormone receptor-positive, HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. This study focuses on patients whose cancer has either locally advanced or metastatic disease and have previously received specific hormone and targeted therapies. The goal is to see if treatment with patritumab deruxtecan can help patients live longer or delay cancer progression compared to other chemotherapy options or trastuzumab deruxtecan. Participants are randomly assigned to receive either patritumab deruxtecan through intravenous infusion every three weeks for about 13 months or a treatment chosen by their doctor, which may include various chemotherapy drugs or trastuzumab deruxtecan. The study treatment options in the doctor’s choice group are given on different schedules, such as weekly or every three to four weeks, depending on the drug selected. Throughout the study, participants will be closely monitored with regular assessments to measure progression-free survival and overall survival for up to approximately 45 and 85 months respectively. Researchers will also evaluate tumor response, quality of life using specific questionnaires, and track any side effects. The study includes long-term follow-up to understand the impact of treatment over time and ensure participant safety.

Researchers are evaluating the safety and effectiveness of zilovertamab vedotin (ZV) combined with standard treatments for people with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). This Phase 2/3 study aims to see if adding ZV to rituximab, gemcitabine, and oxaliplatin (R-GemOx) improves progression-free survival compared to R-GemOx alone. The study is divided into two parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2). Cohort B involving ZV plus bendamustine rituximab (BR) was discontinued and will not be analyzed for efficacy.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups: one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

Researchers are evaluating the effectiveness and safety of combining standard chemotherapy and bevacizumab with or without the drug INCA33890 as first-line treatment for metastatic microsatellite stable colorectal cancer. This phase 3 randomized, double-blind study aims to compare these treatment approaches in patients with advanced colorectal adenocarcinoma who have not received prior systemic treatment for unresectable or metastatic disease. Participants will be randomly assigned to receive either INCA33890 with bevacizumab and FOLFOX chemotherapy or a placebo with bevacizumab and FOLFOX, all administered at protocol-defined doses. This trial includes two groups: one getting the experimental drug INCA33890 plus standard treatment, and the other receiving placebo plus standard treatment, to evaluate treatment effects over time. During the study, participants will undergo regular assessments including tumor measurements by RECIST criteria, monitoring of adverse events, and quality of life questionnaires such as the EQ-5D-5L and EORTC QLQ-C30. The primary outcome is progression-free survival over up to three years, with secondary outcomes including overall survival, treatment response, duration of response, and safety measures tracked for up to four years. Adequate organ function and performance status will be evaluated at baseline and throughout the trial.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors (ICIs). The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA (ctDNA) after surgery. This Phase II/III trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.

Researchers are evaluating different combinations of drugs to treat newly diagnosed multiple myeloma in patients who are not eligible for stem cell transplant and are considered frail or intermediate-fit based on age, other health conditions, and functional status. This phase III trial compares three induction regimens followed by either single or double maintenance therapy to see which combination works best to control the cancer and improve survival. The study also examines patient quality of life, safety, and other treatment effects over time. Patients are randomly assigned to one of three treatment groups. The first group receives bortezomib, lenalidomide, and dexamethasone for up to nine 28-day cycles, followed by lenalidomide maintenance. The second group receives daratumumab and hyaluronidase-fihj, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. The third group has the same induction as the second group but receives both daratumumab and lenalidomide during maintenance. Treatments are given by injection or orally on specific days within each cycle, and continue as long as the disease does not progress or side effects are unacceptable. Participants undergo assessments including tumor measurements, blood tests, patient-reported questionnaires, and blood sample banking for future research. After completing treatment, patients are followed up every three months for one year, then every six months for two years, and annually for up to ten years to monitor progression, survival, and quality of life. The main outcomes measured are progression-free survival and overall survival, with additional evaluations of response rates, safety, and symptom reports up to ten years after starting the study.

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 investigator’s 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 investigating treatments for pre- and postmenopausal women and men with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has an ESR1 mutation. Participants must have previously received ribociclib or palbociclib-based therapy and show progression after treatment with an aromatase inhibitor (AI). The study compares the effects of two drug combinations to evaluate their safety, tolerability, and ability to control the cancer. Participants are randomly assigned to receive one of two treatment combinations. One group takes oral lasofoxifene 5 mg daily along with oral abemaciclib 150 mg twice a day. The other group receives intramuscular fulvestrant 500 mg on Days 1, 15, and 29, then monthly thereafter, combined with oral abemaciclib 150 mg twice daily. The study is open-label and conducted across multiple centers. During the trial, participants will be monitored regularly for progression-free survival, objective tumor response, overall survival, clinical benefit, and quality of life using specific questionnaires. Researchers will also assess the duration and time to response, time to chemotherapy, and record any adverse events. The study period for these assessments is approximately three years, ensuring continuous evaluation of treatment effects and safety.