View clinical trials related to Breast Neoplasms.
Filter by:This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide work to prevent the recurrence of stage 1-3 triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide may work well together to prevent cancer recurrence after surgery and other standard treatments for triple negative breast cancer.
This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a single agent in patients with locally advanced or metastatic PIK3CA-mutant solid tumors, including breast cancer, and in combination with standard-of-care endocrine and/or targeted therapies for the treatment of locally advanced or metastatic PIK3CA-mutant breast cancer. Participants will be enrolled in two stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants will be assigned to one of seven regimens: inavolisib as a single agent (Arm A), inavolisib in combination with palbociclib and letrozole (Arm B), inavolisib in combination with letrozole (Arm C), inavolisib in combination with fulvestrant (Arm D), inavolisib in combination with palbociclib and fulvestrant (Arm E), inavolisib in combination with palbociclib, fulvestrant, and metformin (Arm F), and inavolisib in combination with trastuzumab and pertuzumab (and letrozole or fulvestrant, if applicable (Arm G)).
The purpose of this study is to invite all people diagnosed with cancer who meet the eligibility criteria to complete questionnaires before their treatment begins and at regular intervals over time to assess the impact of cancer and its treatment on people's lives in the short, medium and long term. We will explore a range of factors to determine their role in both recovery of health and well-being and self-management. Although it is known that people who have had cancer are likely to experience a number of physical and psychological problems as a result of the disease and treatment, it is not known what the 'typical' course of recovery of health and well-being looks like, how long it takes and how this can be influenced. We will determine pathways to recovery of health and well-being following cancer diagnosis (initially breast cancer diagnosed <50 years, Non-Hodgkin Lymphoma and gynaecological cancers) and identify what factors influence this. This includes assessing the relative importance of the person's illness, personal attributes, perceived burden of treatment, role of the environment they live in, including health / social care and personal networks of support, and their ability and capacity to self-manage. We will identify who is most at risk of problems and what environmental supports and resources people are able to mobilise to support their self-management. We will also explore who has the confidence and ability to manage during and beyond treatment and what factors influence this and whether this leads to earlier problem resolution and restoration of health and well-being. This knowledge will be used to develop and test future supportive interventions to enhance the rapid recovery of health and well-being - our long term aim being to design ways of helping people with cancer in areas we identify as problematic for them.
This research study is exploring chemotherapy in combination with immunotherapy (a therapy that uses the body's own immune system to control cancer) as a possible treatment for hormone receptor positive breast cancer. The interventions involved in this study are: - Pembrolizumab (MK-3475; Keytruda™) - Nab-Paclitaxel (Abraxane
The BENEFIT-Study is a randomized controlled 3-arm intervention trial investigating the currently discussed hypothesis that exercise concomitant to chemotherapy (CTx) may have a beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics or by enhancing therapy compliance. This hypothesis is based on pre-clinical and exploratory clinical trials. Breast cancer patients scheduled for neoadjuvant CTx will be randomized to either a resistance training or an aerobic training concomitant to the neoadjuvant CTx, or a waiting list control group that will get no exercise intervention during neoadjuvant CTx (i.e. usual care) but will exercise after breast surgery. The primary study endpoint is the tumor size. Further, the effects of resistance and aerobic exercise on the clinical-pathologic stage (CPS-EG) score, the pathological complete response (pCR), tolerability and compliance to CTx, physical fitness, patient reported outcomes such as fatigue, sleep problems, quality of life, depressive symptoms, anxiety and pain, as well as cognitive function, and selected biomarkers will be investigated. A confirmation of the study hypothesis would be a strong argument for patients to engage in exercise as early as during neoadjuvant CTx. The trial will also provide evidence-based guidance for patients regarding type and timing of training.
This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to informing women about their risk of breast cancer and the screening methods recommended for them according to the recommendations in force during a routine consultation at a general practitioner, a gynecologist or a radiologist.
The Cardio-Oncology program at Northwestern offers care to cancer patients who develop cardiac toxicities from chemotherapy. Breast cancer patients with the tumor marker for HER2 necessitate treatment with anthracycline and/or trastuzumab and pertuzumab-based chemotherapies, which are known to cause cardiac toxicities. Breast cancer patients will undergo a "cardio-oncology echocardiogram" which incorporates advanced left ventricular assessment by utilizing deformation or strain imaging during chemotherapy treatment for surveillance of cardiac toxicities. The aims of this project are: 1. To create a registry of both clinical, and echocardiographic variables, biomarkers, and genetic analysis that will be used to develop a risk model to predict LV dysfunction in early stage breast cancer patients undergoing chemotherapy with anthracycline and/or trastuzumab and pertuzumab-based chemotherapy regimens. 2. To propose a new management algorithm for initiation of prophylactic beta-blocker therapy for early stage breast cancer patients with preclinical cardiac toxicities demonstrated by strain parameters. 3. To determine if initiation of prophylactic beta-blocker therapy in patients with early cardiac toxicity can delay or prevent a drop in LV EF and the development of clinical heart failure. 4. To explore serial measurements of a suite of novel biomarkers during ongoing anticancer treatment that are presumed but not yet proven to be predictive of cardiac dysfunction in women with breast cancer. 5. To identify DNA biomarkers of predilection to cardiotoxicity. 6. To generate hiPSC to validate markers predictive of cardiotoxicity.
Women who have undergone breast cancer surgery may develop swelling of the arm on the side the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This study will examine the effect of a 12-week decongestive progressive resistance exercise with advanced compression on breast cancer related lymphedema. Our objective is to determine if breast cancer survivors are willing and able to wear advanced compression while exercising and if the combination will help to reduce their lymphedema. Twenty-four breast cancer survivors from Edmonton, Alberta will be enrolled in the one-year long study.
Breast cancer is the leading cancer diagnosed in women and the second cause of cancer death. Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years, this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are more likely to die from their breast cancer as ER positive White women. Preliminary data suggest that non-adherence to adjuvant hormonal therapy could explain some of this disparity. To date, no study has systematically examined psychosocial, healthcare, and biological factors that predict adherence to hormonal therapy in Black women with breast cancer. To begin to fill this knowledge gap, Investigators will conduct a prospective cohort study of 422 ER positive Black breast cancer patients recruited from health maintenance organizations (HMOs). Our primary outcome is adherence to therapy at 36 months post initiation. Specific aims are to: 1) Examine psychosocial factors (e.g. health beliefs, socio-cultural values, etc.) that predict adherence to hormonal therapy; 2) Identify clinical (e.g., side effects), and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy; and 3) Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that predict adherence. Investigators will also explore the role of CYP2D6 genetic variations in adherence to hormonal therapy which is novel and will increase knowledge about this genetic factor in Blacks. The study is focused on the time-period (first 3 years) when women appear to be the most vulnerable to terminating treatment prematurely. A better understanding of predictors of adherence in Black women may help target interventions and ultimately improve potentially avoidable adverse breast cancer outcomes in this underserved group.
Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.