Concepcion

Researchers are investigating new treatment options for breast cancer that is hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2-, specifically for cases that are unresectable locally advanced or metastatic. This type of breast cancer involves cancer cells that depend on hormones like estrogen or progesterone and have low HER2 protein levels. The study focuses on comparing the effects of patritumab deruxtecan against chemotherapy or trastuzumab deruxtecan in patients whose cancer has progressed despite prior treatments. Participants receive either patritumab deruxtecan through intravenous infusions every three weeks for about 13 months or a treatment chosen by their physician, which may include various chemotherapy drugs or trastuzumab deruxtecan, administered according to specific schedules for up to 13 months. The study is randomized and open-label, meaning participants are randomly assigned to one of the treatment groups, and both the patients and researchers know which treatment is given. Throughout the study, participants undergo regular assessments to monitor cancer progression and overall survival for up to approximately 85 months. Researchers evaluate tumor response, duration of response, and changes in quality of life using standardized questionnaires. Safety is carefully monitored by recording adverse events and treatment discontinuations. The goal is to understand if patritumab deruxtecan can improve outcomes compared to current treatment options.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are studying MK-5684, a medicine designed to block steroid hormone production, to treat breast cancer, ovarian cancer, and endometrial cancer. The trial compares MK-5684 with standard treatments for these cancers to see if participants live longer without their cancer growing or spreading. The study is a Phase 2, open-label trial with multiple cancer types included. Participants with breast, ovarian, or endometrial cancer will be assigned to different treatment groups. Those with breast cancer receive MK-5684 plus corticosteroids or endocrine therapies like fulvestrant or exemestane. Ovarian cancer participants are observed without treatment during the study. Endometrial cancer participants receive one of several treatments chosen by their doctors, including megestrol acetate, tamoxifen, or letrozole. Treatments continue until reasons to stop arise. During the study, participants take oral medications and may receive injections depending on their group. Researchers monitor how long participants live without cancer progression, overall survival, response rates, and side effects. The study lasts up to about two years, with safety and treatment effects tracked throughout. Participants are regularly assessed for adverse events and treatment benefits to understand MK-5684s impact compared to other therapies.

Researchers are evaluating the drug opevesostat in a phase 3, randomized, open-label study for men with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with next-generation hormonal agents and taxane-based chemotherapy. The study aims to compare overall survival between participants receiving opevesostat and those receiving alternative treatments, including abiraterone acetate or enzalutamide. The research focuses on participants with specific androgen receptor mutations to determine if opevesostat provides better outcomes. Participants are assigned to one of two groups one group receives opevesostat 5 mg orally twice daily along with dexamethasone and fludrocortisone acetate daily, with hydrocortisone available as rescue medication. The other group receives either abiraterone acetate 1000 mg daily plus prednisone 5 mg twice daily or enzalutamide 160 mg daily. Treatments continue until disease progression, with prior prednisone use replaced by hydrocortisone in later protocol versions. During the study, participants undergo regular assessments including scans and laboratory tests to monitor prostate cancer progression and treatment effects. Researchers measure overall survival and several secondary outcomes such as progression-free survival, response duration, pain progression, and adverse events for up to approximately 54 months. The study also tracks safety and treatment discontinuation, with ongoing evaluations throughout the treatment period and follow-up.

Researchers are evaluating the safety and effectiveness of volrustomig in women with high-risk locally advanced cervical cancer FIGO 2018 stage IIIA to IVA who have not experienced disease progression following platinum-based concurrent chemoradiation therapy CCRT. This phase III, randomized, double-blind, placebo-controlled global study aims to compare volrustomig with a placebo to gain insights into treatment outcomes for this patient group. Participants will be randomly assigned in a 11 ratio to receive either volrustomig or a placebo by intravenous infusion. The study compares these two groups over time to assess progression-free survival and other important outcomes. Treatment is given after patients complete platinum-based CCRT and have no disease progression. The study includes long-term follow-up for up to approximately seven years to monitor various measures such as survival, response rates, and side effects. Throughout the study, participants will undergo regular assessments including tumor sample analysis, physical exams, and evaluations of organ function and overall health. Researchers will track progression-free survival, overall survival, response rates, and patient-reported symptoms and quality of life. Safety and adverse events related to volrustomig will also be monitored closely during the study and follow-up period. Participation involves a long-term commitment with ongoing monitoring for up to seven years.