View clinical trials related to Breast Neoplasms.
Filter by:This phase II trial studies how well giving lapatinib ditosylate together with trastuzumab, paclitaxel, and surgery works in treating patients with breast cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Acute radiation skin reactions (ARSR) occur in the majority of patients undergoing postoperative radiotherapy (RT). Some patients experience more severe reactions such as dry and/or moist desquamation but most patients experience mild reactions e.g. erythema (Lopez et al., 2005). The radiation dose, volume, RT technique and previous treatment, such as type of surgery and previous chemotherapy, are factors that might impact on the risk for ARSR together with patient-related factors such as body mass index (BMI), smoking status and previous skin damage (Porock et al., 1998; Wells et al., 2004). In a pilot study (n=93) of the frequency of ARSR in patients with breast cancer who underwent adjuvant RT it was shown that 93% developed ARSR, mostly mild reactions. Patients reported low scores on pain and itching (Sharp et al., 2011). Over 80% of the patients reported adherence to the skin care recommendations which included application of a thin layer of Essex® cream, a non-perfumed aqueous cream, on the irradiated area at least two times a day (Sharp et al., 2011). The effects of skin care products containing Calendula Officinalis (marigold plant) on ARSR in patients with breast cancer were investigated in a randomized clinical trial (Pommier et al., 2004). Patients in the experimental group, treated with calendula cream had a statistically significant lower incidence of severe ARSR, pain and treatment interruptions in comparison with the patients in the control group, treated with trolamine. The purpose of this blinded, randomized clinical trial is to compare two topical agents, Calendula Weleda® cream and Essex® cream, in terms of efficacy to reduce the risk of severe acute radiation skin reactions (ARSR) in relation to adjuvant radiotherapy (RT) for breast cancer. Patients were instructed to apply a thin layer of the assigned cream twice a day, starting at the onset of RT and continue until two weeks after termination, or until the ARSR is healed. The application should include the whole treatment area including the armpit and shoulder/back area in patients treated with modified radical mastectomy. Patients are also advised to not apply the cream within two hours before the RT in order to avoid possible build-up effect. Daily wash with perfume free soap and tap water are recommended and patients are advised to refrain from use of other topical agents in the irradiated area. The primary endpoint is the efficacy to reduce acute radiation skin reactions (ARSR), assessed with the Radiation Therapy Oncology Group/The Organization for Research and Treatment of Cancer Acute Radiation Morbidity Scoring Criteria (RTOG/EORTC scale) at follow-up. Secondary endpoints include patient reported outcome measures; Quality of Life Questionnaire (QLQ-C30), Sleep disturbances (MOS-sleep questionnaire) and symptoms experienced from the irradiated area (visual analogue scale). Patients' experiences and adherence to the topical agents are also evaluated. A total of 400 patients are required to detect a true absolute reduction in the proportion of patients with ARSR, from 35% with standard treatment (Essex® cream) to 20% with the experimental treatment (Calendula Weleda® cream), with a significance level of 5% a power of 90%. With this sample size, 95% confidence intervals for the difference in proportions are estimated to be in the order of ±10%. Assuming a rate of 5% of non-responders, the target size has been set to 420 patients.
This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.
Recent studies have shown that some behavioral factors such as physical activity and exercise may improve quality of life and outcome in patients with breast cancer as well as decrease body fat, increase lean mass and reduce cancer-promoting hormones. None of these studies have been performed in African-American women with breast cancer. The medical field needs to understand how exercise may benefit cancer patients, particularly African Americans, and how to optimize these benefits to improve the quality of life, prognosis and survival.
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary efficacy, and PK profile of PD-0332991 as a single agent in Japanese patients with advanced solid tumors, and PD-0332991 in combination with letrozole in the first-line treatment of Japanese patients with ER(+) HER2(-) ABC. The Phase 2 portion is a single-country, non-randomized, open-label, single-cohort, multi-center clinical trial to evaluate the efficacy and safety of PD-0332991 in combination with letrozole for the first-line treatment of postmenopausal Japanese patients with ER(+) HER2(-) ABC.
The purpose of this study is to determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.
The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced breast cancer. Once this is defined, dose expansion will be performed at this MTD in patients with metastatic or locally advanced and unresectable triple negative breast cancer, to evaluate the efficacy of combined dinaciclib and pembrolizumab.
A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. Chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern. Mindfulness-based intervention is among the complementary, psychological treatments, which cancer patients commonly seek out in relation to the course of their illness. Despite the popularity of mindfulness-based intervention among cancer patients, no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients. While no studies so far have focused on pain, there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer. Furthermore, non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences. The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment for breast cancer and who experience chronic pain, will be randomized to an intervention group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the same time points, i.e. before the intervention (baseline), and three times after the intervention/control condition, with the last follow-up 6 months after the intervention. In addition, a number of potential moderators and mediators of the outcome will be explored. For example, recent studies indicate that adult attachment style may constitute an important moderator and/or mediator in the development of pain, and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention. The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients, will contribute to the clarification of underlying mechanisms in the experience of and coping with pain, which could help the development of more effective, individualized interventions.
This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy. Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy
This randomized phase I trial studies at-home group video calling sessions in quality of life in rural patients with breast cancer. At-home group video calling support sessions may improve the well-being and quality of life of women who have breast cancer