Sault Ste Marie

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 the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are studying women with a newly diagnosed invasive breast cancer that is node negative and 3 cm or smaller in size to compare two types of radiation therapy after breast-conserving surgery BCS. The study aims to see if partial breast irradiation PBI given once daily over one week is not worse than whole breast irradiation WBI in preventing cancer return and whether it results in better cosmetic outcomes. This is a randomized, single-blind trial focusing on local recurrence and patient-assessed cosmesis three years after treatment. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total of 26 Gy radiation in 5 fractions, given once daily over 5 to 7 days with up to 8 days allowed for scheduling reasons. PBI targets the tumor bed plus a margin of normal tissue, while WBI targets the whole breast. Patients will not know which treatment they receive to avoid bias in cosmetic assessments. Stratification factors include tumor size, estrogen receptor status, and clinical center. During the study, participants will be monitored for local recurrence annually for five years and will assess their cosmetic outcome at three and five years post-treatment. Researchers will also evaluate survival, disease-free survival, radiation side effects, and quality of life at various intervals. Clinical assessments and nurse evaluations of cosmesis will occur at three and five years. Overall, participant involvement spans several years with multiple follow-up visits to measure outcomes and safety.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor CDK46i and letrozole compared to placebo plus CDK46i and letrozole in adults with endocrine-sensitive PIK3CA-mutated hormone receptor-positive HR, HER2-negative advanced breast cancer. This phase III, randomized, double-blind study focuses on participants who have measurable disease and meet specific hormone receptor and HER2 status criteria. Participants are randomly assigned to receive either oral inavolisib once daily along with letrozole and CDK46i or placebo once daily with letrozole and CDK46i. The CDK46i is given on a schedule of either Days 1-21 or Days 1-28 of each 28-day cycle. The study includes parallel groups to compare these treatment combinations over time. During the study, participants will be monitored for progression-free survival, overall survival, response rates, duration of response, clinical benefit, and changes in pain, physical function, and global health status. Safety will be assessed by tracking adverse events and patient-reported treatment side effects using questionnaires. The study will follow participants for up to seven years, with regular evaluations to track disease status and quality of life.

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 investigating new treatments for people with proficient mismatch repair pMMR endometrial cancer that is advanced or has returned after surgery. This cancer starts in the tissues inside the uterus and has spread locally or to other parts of the body, making it not removable by surgery. The study aims to learn if combining sacituzumab tirumotecan sac-TMT with pembrolizumab helps people live longer and without their cancer worsening compared to pembrolizumab alone. All participants first receive an Induction Phase of six cycles, each lasting three weeks, which includes pembrolizumab combined with carboplatin or cisplatin and paclitaxel or docetaxel. Those whose cancer does not progress then enter a Maintenance Treatment Phase and are randomly assigned to receive either pembrolizumab plus sac-TMT or pembrolizumab alone. If the cancer progresses, participants may enter a Subsequent Treatment Phase where they are randomly assigned to pembrolizumab plus sac-TMT or sac-TMT alone. During maintenance and subsequent phases, sac-TMT is given on Days 1, 15, and 29 of each 6-week cycle, and pembrolizumab is given on Day 1 of each 6-week cycle. Participants are involved throughout the study, receiving intravenous treatments over several months and up to 14 maintenance cycles lasting about 19 months. Researchers will monitor cancer progression and survival up to approximately 44 to 54 months. They also assess safety by tracking adverse events and quality of life using questionnaires. The study requires regular visits for treatment and evaluation over this period to understand how well the treatments work and their effects on participants.

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

Researchers are investigating advanced small cell lung cancer SCLC in adults to determine if adding a medicine called obrixtamig to the standard treatment of atezolizumab, carboplatin, and etoposide improves survival compared to the standard treatment alone. Obrixtamig is a molecule designed to help the immune system fight cancer. The study also tests a new medical device that measures levels of the tumour marker DLL3. This is a phase III clinical trial sponsored by Boehringer Ingelheim, using a randomized design to compare treatments. Participants are randomly assigned to one of two groups. One group receives obrixtamig together with the standard treatment, while the other group receives only the standard treatment. All treatments are given through infusions into a vein. Participants receiving obrixtamig will stay overnight at the study site after their first two treatments. The study lasts up to three years, during which tumour size and health status are regularly checked. Throughout the study, participants visit the study site regularly for assessments. Doctors monitor tumour response and check for any side effects or unwanted reactions. The main outcome is overall survival measured up to 36 months. Additional outcomes include progression-free survival, symptom changes, response rates, and monitoring of treatment-related side effects. The study team closely tracks participant health and evaluates quality of life using questionnaires during the first year.

Researchers are studying whether stopping daratumumab or isatuximab treatment after about a year and a half is as effective as continuing these treatments without stopping in older adults newly diagnosed with multiple myeloma who are not eligible for stem cell transplant. This trial compares fixed duration therapy versus continuous therapy alongside lenalidomide and dexamethasone, with some participants also receiving bortezomib. The study is a Phase III randomized trial designed to answer if less anti-CD38 antibody treatment works as well as ongoing treatment. Participants are randomly assigned to one of two groups. In the usual care group, patients continue all their current myeloma medications including daratumumab or isatuximab injections. In the experimental group, patients stop the daratumumab or isatuximab injections but continue taking lenalidomide and dexamethasone tablets. Treatment continues indefinitely as long as patients benefit from it. Doses for daratumumab, isatuximab, lenalidomide, and dexamethasone are determined when participants enroll. During the study, participants will be monitored for how long they live without their disease worsening, overall survival, response to treatment, side effects, time until next treatment, and quality of life using questionnaires. Researchers will also assess treatment-related side effects and economic outcomes over about 9 years. Participants must complete quality of life and health utility questionnaires in English, French, or validated languages and will be followed regularly to assess these outcomes and safety over the course of the study.