Understanding CARdiac Events in Breast Cancer - Pilot Cardio-Oncology Assessment and Surveillance Pathway for Breast Cancer Patients
In Ireland, over 3,000 patients are diagnosed with breast cancer annually, and 1 in 9 Irish women will be diagnosed with breast cancer in their lifetime. There is evidence that female breast cancer survivors are more likely to die of cardiovascular disease than their age-matched counterparts. This research is focused on evaluating pathways for identifying, managing, and overcoming side effects of cancer therapies that can negatively impact quality-of-life and overall outcomes for women during and after cancer treatment. The Cardio-oncology research team at GUH plan to capitalize on their expertise in both cancer care and cardiology to develop a care pathway for cancer patients who are at increased risk of developing heart disease.
NCT05921279 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05921279/
A Prospective Study to Evaluate the Effectiveness of Thermalytix (AI-based Thermographic Solution Developed by Niramai) for Breast Cancer Screening as Compared to Standard Screening Modalities for Breast Cancer
The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.
NCT04688086 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT04688086/
Restoring Body Image After Breast Cancer Through Exercise and Art Sculpture "RISE UP" After Breast Cancer: A Pilot Multi-Methods Study
The objectives of this pilot study are to determine the feasibility of a community-based moderate intensity resistance exercise training (RET) program in combination with an art sculpting class on body image in breast cancer survivors (BCS). The protocol will be measuring recruitment; attendance; cost tracking; body image distress; body image appreciation; and muscular strength. Participant feedback on the intervention will be collected through a final focus group. Additionally, cognitive interviews will occur prior to the intervention, where participants will be asked to "think-out-loud" as they answer the Body Image Scale for Cancer questionnaire. The purpose of this interview technique is to gain a deeper understanding of the participants' thought process behind choosing each answer. The proposed pilot study will be a single prospective before and after study that will help inform a future large-scale project. A minimum sample of 12 subjects will be recruited. The Health Research Ethics Board of Alberta Cancer Committee will approve this study. Participants will participate in RET biweekly for 12 weeks and the sculpting class weekly for 8 weeks. After the first week of RET, the art class will begin. Both the RET and sculpting class will be between 1-2 hours in length. Analyses: Quality of life, fitness testing and body image scales will be administered before and after the intervention. Cognitive interviews will occur once before the intervention has started and a final focus group will occur at the end of the intervention to get participant feedback on the effectiveness of the program
NCT04088877 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT04088877/
Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First/Second Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study
This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).
NCT04030507 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT04030507/
Evaluation of Endocrine Therapy and Patients Preferences in Early Breast Cancer - Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer.
Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile. They are especially relevant to adjuvant therapies where individuals must weigh up modest survival benefits only realized in time by no recurrence of their cancer with side effects predominantly experienced whilst on the treatment. Previously it was reported, for example, that over 50% of women who had adjuvant chemotherapy for early breast cancer judged a 1% improvement in 5 year survival rates sufficient to make it worthwhile. Larger survival benefits were required for longer duration adjuvant hormonal therapy where over 50% of women required at least 5% improvement in 5 year survival rates to make it worthwhile.
NCT03939156 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT03939156/
The Effect of Statins on Markers of Breast Cancer Proliferation and Apoptosis in Women With Early Stage Breast Cancer
The purpose of this pilot phase II trial is to identify the molecular and genetic mechanisms by which statins influence breast cancer cell proliferation. Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and reduce the aggressiveness of breast cancer cells.
NCT03454529 — Invasive Breast Carcinoma
Status: Completed
http://inclinicaltrials.com/invasive-breast-carcinoma/NCT03454529/
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
The most important consideration in the design of this clinical trial is to ensure the safe translation of the personalized synthetic long peptide vaccine strategy. The Food and Drug Administration (FDA) dictates that initial studies of biologic therapies be performed in such a way that there is a balance between the potential risks and benefits in individual patients. Consistent with these recommendations, the investigators will target patients with triple-negative breast cancer who do not have a pathologic complete response after neoadjuvant chemotherapy. These patients typically have no gross evidence of disease following standard of care therapy (neoadjuvant chemotherapy, surgery and radiation therapy) but are at extremely high-risk for disease recurrence. Targeting this patient population provides a window-of-opportunity to design and manufacture the personalized cancer vaccines, maximizes the potential benefit from the vaccine as the regulatory networks associated with metastatic disease are not present, and balances risk in this patient population with extremely high risk for disease recurrence but no other treatment options.
NCT02427581 — Triple Negative Breast Cancer
Status: Withdrawn
http://inclinicaltrials.com/triple-negative-breast-cancer/NCT02427581/
Phase I/II Study of Cisplatin Plus Romidepsin and Nivolumab in Metastatic Triple Negative Breast Cancer or BRCA Mutation-Associated Locally Recurrent or Metastatic Breast Cancer
Study combination use of cisplatin plus romidepsin and nivolumab in metastatic triple negative breast cancer (TNBC) or BRCA mutation-associated locally recurrent or metastatic breast cancer
NCT02393794 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT02393794/
Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology: An Ex-vivo Pilot Study of Real-time Breast Margin Imaging in Women Undergoing Breast Conservation Surgery for Early Stage Breast Cancer
This study will evaluate LumaScan, an innovative polarization microscope for real time, intraoperative imaging and evaluation of the surface of excised tissue excised during Breast Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators hypothesis is that LumaScan will be comparable for cancer detection to conventional histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and loss of confidence in the tissue conservation surgery procedure.
NCT02207179 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT02207179/
Phase II Study of Simvastatin in Primary Breast Cancer; Test of Its Potential Selectivity on Basal Subtype Breast Cancer
We hypothesize that Simvastatin administration would result in selective killing of the basal subtype of breast cancer, in particular, CD44+/CD24- breast cancer cells in primary tumor. We further hypothesize that tumor genomic changes would correlate with tumor response to Simvastatin. We are also looking to correlate Simvastatin biological effects with the expression pattern of initial status of primary tumor. In addition, we hypothesize that Simvastatin-induced tumor gene expression changes may correlate with tumor and plasma proteomics, peripheral blood mononuclear cell gene expression changes, and pharmacogenetics, and that these analyses may further refine the selection of patients most likely to benefit from Simvastatin.
NCT00807950 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT00807950/