North Sydney

Researchers are evaluating two types of radiation treatments for women with small, node-negative breast cancer (3 cm or smaller) after breast-conserving surgery. The study aims to find out if partial breast irradiation (PBI) given once a day over one week is not worse than whole breast irradiation (WBI) in preventing cancer from coming back locally and if it leads to better cosmetic outcomes as assessed by patients three years after treatment. This is a phase 3 randomized trial focusing on the comparison of these two radiation approaches. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total radiation dose of 26 Gy divided into 5 daily sessions over 5 to 7 days (up to 8 days allowed due to holidays). The radiation is carefully targeted to the appropriate breast area, and the study is single-blinded so that patients do not know which treatment they receive to avoid bias in cosmetic assessments. Treatment planning includes using CT imaging and surgical markers for accurate delivery. During the study, participants will be monitored annually for five years to check for local cancer recurrence. Cosmetic outcomes will be assessed by patients themselves at three and five years post-treatment. Other evaluations include tumor characteristics and receptor status, and treatment safety will be observed. The total participation involves follow-up over several years to understand long-term effects of the treatments.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Researchers are evaluating the safety and early effectiveness of DB-1311 combined with either BNT327 or DB-1305 in adults with advanced or metastatic solid tumors. This phase II, multicenter, open-label trial includes participants with several types of cancer, including hepatocellular carcinoma, cervical cancer, melanoma, head and neck squamous cell carcinoma, platinum-resistant ovarian cancer, and non-small cell lung cancer. The study focuses on targeted patients whose cancers have recurred, progressed, or are difficult to treat. The trial involves two treatment combinations delivered intravenously: DB-1311 with BNT327, and DB-1311 with DB-1305. Participants receive these investigational drug combinations under close observation. The study is divided into two parts: the first part evaluates dose-limiting toxicities within 21 days after the first dose, while the second part assesses treatment safety and response rates up to 72 months. This design allows researchers to monitor both short-term safety and long-term treatment effects. During the study, participants undergo regular assessments including monitoring for adverse events, tumor response evaluations using RECIST criteria, and organ function tests. The primary outcomes include the number of participants experiencing dose-limiting toxicities early in treatment and the objective response rate, which measures the proportion of participants showing significant tumor shrinkage. Safety monitoring continues throughout the study duration, with follow-up visits extending up to six years to observe long-term effects and participant health.

Insomnia is a common sleep disorder where people have trouble falling asleep, staying asleep, or getting good quality sleep, leading to daytime sleepiness, poor memory, and concentration problems that affect social and work life. Although many use medical cannabis products for insomnia symptoms, there is limited clinical evidence on the effects of cannabidiol (CBD) for sleep disorders. This Phase III study evaluates whether nightly doses of 75mg or 150mg of CBD over 8 weeks can improve patient-reported sleep quality compared to a placebo. Participants will receive either 75mg CBD capsules, 150mg CBD capsules, or placebo capsules each night for 8 weeks. The study is randomized, double-blind, and placebo-controlled to compare the effects of these treatments on insomnia severity and sleep efficiency. No other specific treatment details or additional study periods are described. During the study, participants will be monitored for changes in insomnia severity index (ISI) scores and sleep efficiency from baseline to 8 weeks. Researchers will collect patient-reported sleep quality data and assess safety throughout the treatment period. Participants are expected to comply with study procedures and provide consent before enrollment, with the study duration lasting at least 8 weeks.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

Researchers are evaluating the long-term safety of nivolumab monotherapy, including its use with combinations and other cancer treatments, in patients with various types of cancer. This Phase 2 study focuses on patients who have previously participated in Bristol-Myers Squibb (BMS) sponsored trials involving nivolumab and other cancer therapies. The goal is to gather information on safety over an extended period following treatment. Participants may receive nivolumab alone or alongside other cancer drugs such as ipilimumab, cabozantinib, trametinib, relatlimab, capecitabine, bevacizumab, and others. Each drug is given at specified doses on designated days according to the study protocol. Treatment continuation or rechallenge is based on the participant's status from their prior parent study, including treatment holds after lasting responses or eligibility for restarting treatment. During the study, participants will be closely monitored for adverse events, including general, drug-related, serious, immune-mediated, and select adverse effects, as well as any deaths, from the start of treatment until 135 days after stopping treatment. Safety assessments and clinical evaluations will be conducted regularly to track these outcomes and ensure participant well-being throughout the trial.

Researchers are evaluating treatments for patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer that has a PIK3CA mutation. This Phase 3 study compares the effectiveness and safety of RLY-2608 combined with fulvestrant versus capivasertib combined with fulvestrant. The study focuses on patients whose cancer returned or worsened after treatment with a CDK4/6 inhibitor. Participants will receive either RLY-2608 taken orally twice daily every day in 28-day cycles or capivasertib taken orally twice daily on days 1 through 4 each week within a 28-day cycle. All participants will also receive fulvestrant by intramuscular injection on day 1 and day 15 of the first cycle, then on day 1 of each following 28-day cycle. Treatment continues until disease progression or other criteria are met. During the study, researchers will monitor participants regularly to assess progression-free survival, which is the time from starting treatment until cancer progression or death. Assessments include radiographic imaging based on RECIST v1.1 criteria and safety evaluations. The study duration may extend up to approximately 77 months, allowing for long-term monitoring of treatment effects and safety.

Researchers are investigating whether magnetic resonance imaging (MRI) results can help select women with early breast cancer who might safely skip radiotherapy after surgery without increasing the chance of cancer returning in the same breast. The study focuses on female patients aged 50 and older with hormone receptor-positive and/or HER2-positive invasive breast cancer. It builds upon earlier findings that combining MRI and pathology can identify patients at low risk of recurrence who may not need radiotherapy, aiming to confirm these results in a larger international setting. The study compares two groups: one where radiotherapy is omitted based on pre-surgical MRI and pathology findings (Arm A), and a standard treatment group receiving usual care including radiotherapy when indicated (Arm B). Patients are selected and assigned to arms based on MRI features such as background parenchymal enhancement and tumour characteristics including size, margin clearance, nodal status, and absence of certain high-risk pathological factors. Treatment decisions and follow-up are guided by these criteria and the surgery performed. Participants will undergo assessments including pre-operative breast imaging, surgery, and pathology review. They will be monitored for cancer recurrence in the breast over a median follow-up of 5 years. Researchers will evaluate the rate of cancer returning on the same side (Ipsilateral Invasive Recurrence Rate) and also study patient-reported outcomes and health economics. The trial includes long-term follow-up to assess safety and effectiveness of omitting radiotherapy in selected patients.

Researchers are evaluating trastuzumab deruxtecan (T-DXd) in adults with unresectable or metastatic breast cancer that is either HER2-low or HER2 IHC 0. This includes patients with hormone receptor-negative or hormone receptor-positive cancer. The study aims to assess the safety and effectiveness of T-DXd by measuring the time patients benefit from the treatment before needing another anticancer therapy. Participants receive T-DXd through an intravenous infusion at a dose of 5.4 mg/kg on the first day of each 21-day cycle. Treatment continues until the disease progresses based on imaging, unacceptable side effects occur, other reasons for stopping arise, or for up to two years after the first dose. The study is open-label, multicenter, and global, focusing on patients who have not previously received anti-HER2 therapy for metastatic disease. During the study, researchers will monitor participants regularly with imaging scans to measure disease progression and collect biopsies. They will also assess heart function, organ health, and overall clinical status. The main outcome is the time from starting T-DXd to the start of the next anticancer treatment or death, followed for up to 24 months. Safety and side effects will be closely observed throughout the study.