Breast Cancer Clinical Trials in Canada

Background: Mastectomies are traditionally performed under general anesthesia (GA), often with the addition of regional anesthesia for post-operative pain relief. Thoracic paravertebral blocks (TPVB) had previously been described in the literature to be sufficient for intra-operative anesthesia as an alternative to GA. A 2021 literature review by Cochrane Library comparing paravertebral anesthesia (with or without sedation) to general anesthesia for patients undergoing oncologic breast surgery showed that TPVB could reduce post-operative nausea and vomiting (PONV), hospital stay, postoperative pain and time to ambulation. It also resulted in greater patient satisfaction compared to GA. The aim of this study is to demonstrate the efficacy of single-injection TPVB done under ultrasound guidance for patients undergoing breast cancer surgery without axillary node dissection. Hypothesis: Single-injection thoracic paravertebral block is non-inferior to multiple (3) injections for oncologic unilateral breast surgery anesthesia. Methods: The current study is a prospective randomized controlled trial of patients undergoing oncologic breast surgery without axillary node dissection or immediate reconstruction. Patients will be randomized into two groups; thoracic paravertebral block (TPVB) single-injection or TPVB multiple (three) injections. Significance/Importance: Oncologic breast surgery performed under TPVB and sedation lowers the risks of post-operative nausea and vomiting, decreases peri-operative use of narcotics, decreases pain scores at rest and on mobilization and leads to better overall patient satisfaction when compared to GA. It also leads to shorter hospital stays. Most studies use multiple injections to perform the block. Even though the risks associated with TPVB are low (3.6 per 1000 surgeries), the single-injection technique could reduce the risks even more. One injection is also easier to perform and of shorter duration, leading to greater patient tolerance and less side effects related to blocks performance duration such as vaso-vagal reactions or general discomfort. To date, no studies have compared the efficacy of single-injection paravertebral block and multiple injection techniques as the main modality of anesthesia for breast cancer surgery. Read Less

Breast cancer is the most commonly occurring cancer in women. Currently, breast conservation surgery (BCS) is the treatment most often prescribed. BCS involves removing the tumor while conserving the greatest amount of healthy breast tissue. Under standard white light, tumor borders are difficult for the surgeons to visualize. Therefore, between 30-70% of patients require a second operation to remove remaining cancerous tissue that wasn't detected during the initial surgery. Thus, there is an urgent clinical need for a new imaging tool that improves tumor visualization during the first surgery. PRODIGI, a new hand-held optical imaging device, uses a safe violet-blue light to detect fluorescence signals in the tissue. Different tissues are associated with specific fluorescent colors and therefore the device can be used to differentiate between tumor and healthy breast tissue. Based on previous clinical data, PRODIGI can distinguish some tumors from normal tissues, but is not specific enough to detect a difference across all breast tumor types. The fluorescent contrast drug 5-aminolevulinic acid (5-ALA) accumulates in tumors naturally and previous research has shown that 5-ALA increases tumor-normal tissue fluorescence contrast. In this observational clinical study, PRODIGI and 5-ALA will be used to visualize tumor borders during BCS. 5-ALA induced fluorescent images from the surgical sample and the surgical bed obtained by PRODIGI will be compared retrospectively with the images taken under standard white light and/or autofluorescence. The technology's ability to accurately identify tumor borders better than conventional practice will be confirmed by tissue pathology. Read Less

This study will investigate optical tissue characteristics as a function of neoadjuvant breast cancer treatment. Our objective in this pilot study will be to identify diffuse optical spectroscopy parameters that change with treatment and that may correlate with pathological response. The ultimate goal is to use such parameters ultrasound as an early predictor of pathological partial or complete response in women with locally advanced breast cancer receiving treatment with neoadjuvant treatments such as chemotherapy or neoadjuvant combined modality chemotherapy and radiotherapy. Read Less

The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage II or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are: 1. What proportion of patients with stage II or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (or computed tomography when Magnetic resonance is not possible) of the brain? 2. How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis? 3. What clinical and tissue-based biomarkers are associated with asymptomatic detection of Brain metastasis? Participants will undergo a brain imaging, collect one blood sample to perform ctDNA analysis, and fill the Testing Morbidities Index (TMI) after imaging is done. Procedures must take place within one year of initial diagnosis, either prior to or after completion of (neo)-adjuvant systemic therapy. Read Less

The primary objective of this study is to assess the feasibility of randomizing breast cancer patients to quantitative ultrasound to guide adaptive Neoadjuvant Chemotherapy as compared to standard clinical monitoring and therapy. The Investigators have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. By detecting cell death early in a treatment on the order of hours to days, rather than traditional anatomical assessments that take place weeks to months after the completion of therapy, ineffective therapies could be switched to more efficacious treatments or aggressive salvage therapy which has shown to already benefit patients. The overarching goal of this research is to transform the delivery of neoadjuvant chemotherapy using quantitative ultrasound (QUS), which is non-invasive, inexpensive and portable. Read Less

Our objective in this pilot study will be to identify PA parameters that can distinguish benign vs. malignant lesions, and also, if PA parameters change with within breast tumors during chemotherapy treatment over time. Read Less

This work explores the possibility of using ultrasound imaging and spectroscopy as a way of monitoring cell death, hence, tumour response to treatment. The hypothesis here is that it can be used as a way of monitoring early response to cancer treatment and predicting which patients continue on in their therapy to have a complete pathological response as a primary endpoint and tumour size decrease as a secondary endpoint. If this work is successful it could be used in the future early on in a cancer patient's treatment to predict whether or not a course of chemotherapy or radiotherapy is going to be successful. For example, in patients in which the analysis indicates a poor response the chemotherapy regimen could be changed to a more efficacious one or for those receiving radiotherapy predicted to have a poor response a radiosensitizing agent could be used to improve outcome. Read Less

Our objective in this study is to identify an optimal set of quantitative ultrasound parameters that can be used, non-invasively, to characterize breast masses with high accuracy, as determined histopathologically. Breast cancer is the most frequent form of non-epithelial cancer diagnosed in women, with approximately 1.5 million new cases diagnosed annually worldwide. Accurate diagnosis and characterization of disease play an important role in therapy planning for breast cancer treatment. Currently, the gold standard method of tumour diagnosis is pathological examination of core biopsy specimens. However, the invasive core biopsies can cause post-surgical complications. Besides, some lesions require repeat biopsy due to sampling errors during the initial biopsy. Also X-ray mammography and ultrasound B-mode images, which are used by radiologists for breast examination, lack reliable information about micro-structural properties of tissues. There is an urgent need of a non-invasive imaging modality that can provide rapid and quantitative information for breast tumour characterization, in real time and at the patient bed. The main goal, as described above, is to select the best quantitative ultrasound parameters that can facilitate breast cancer characterization, non-invasively. Read Less

Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed. Read Less

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life. Read Less

Background: Chemotherapy treatment (CT) can have burdensome side effects such as fatigue, nausea-vomiting, and sleep problems that can significantly affect patients' quality of life. Fatigue is the most common, lasting and bothersome of these, which prevents people from working and carrying out daily activities. Mindfulness-Based Cancer Recovery (MBCR) is an evidence-based group training program which has shown to help treat negative physical and psychosocial symptoms in cancer patients. The investigators propose to evaluate a pilot-tested online-MBCR program for patients undergoing CT who may be low on energy, time or have compromised immunity. Objectives: To evaluate the impact of participation in online MBCR during CT on fatigue (primary outcome), sleep, pain, nausea/vomiting, mood disturbance, stress symptoms and quality of life (secondary outcomes) as well as cognitive function and return to work (exploratory outcomes) over the course of treatment. Methods: The study design is a randomized wait-list controlled trial, conducted during CT for patients with breast or colorectal cancer. Participants will take the 12-week online MBCR program at home within 2 weeks of randomization (immediate group) or after CT completion (waitlist group). Outcomes will be assessed online at, 1) Baseline, 2) Post-MBCR, 3) Post-CT (primary outcome) and 4) 12 months post-baseline. Anticipated Findings: MBCR is a promising adjuvant program that could help patients prevent, delay or diminish aversive symptoms and side-effects associated with CT, particularly fatigue. If helpful, online-MBCR could be made easily available at cancer centers worldwide and significantly lessen the burden of cancer treatments. Read Less

Project EXCEL will provide community or online exercise programs to rural and remote and under-served cancer survivors, as well as encourage participants to become life-long exercisers. Exercise is an evidence-based self-management strategy that benefits all cancer survivors. However, most cancer survivors who live in remote or rural places don't have adequate opportunities to be involved in exercise programs that are tailored to their needs. Read Less