View clinical trials related to Breast Cancer.
Filter by:The first aim of this comparative, randomized, prospective, multicenter study is to evaluate the analgesic effect at 6 weeks of whole-body cryotherapy, compared to placebo cryotherapy, in patients suffering from arthralgia under aromatase inhibitor treatment for hormone-dependent breast cancer in adjuvant situation. The secondary objectives are to evaluate the tolerance of cryotherapy sessions and the evaluation of the impact of the cryotherapy sessions on the consumption of analgesics, the compliance of the treatment by anti-aromatases, the quality of life. The patient and investigator will be blinded to the treatment. Only the cryotherapist will have knowledge of the treatment group: - Whole Body Cryotherapy group (Arm A), or - Placebo Cryotherapy group (Arm B). Patients consulting for the follow-up of a breast cancer and presenting arthralgias under anti-aromatase will be included in the study after verification of the inclusion and non-inclusion criteria and collection of consent. The sessions will be performed according to the randomization arm as follows - Whole body cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 4 minutes 30 seconds. - Placebo cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 1 minute. Each patient will complete the BPI-SF and HAQ questionnaires 15 days +/- 7 days prior to the start of cryotherapy, at the 6 week, 3 and 6 month post-cryotherapy visit. Each patient will indicate the number of days of anti-aromatase therapy in the 6 months prior to inclusion and at 6 weeks, 3 and 6 months after cryotherapy. For this purpose, each patient will indicate the number of hormone therapy tablets taken in the 15 days prior to the inclusion visit, the 6 week, 3 and 6 month visit. Each patient will indicate the analgesic treatments used, classified in three categories: levels 1, 2 and 3 at the inclusion consultation and at 6 weeks, 3 and 6 months after cryotherapy (analgesics taken during the 15 days preceding the visit). The evaluation of the tolerance with the collection of the undesirable effects will be made before and at the end of each session by the professionals of the CryoMed. It will also be evaluated in the week following the end of cryotherapy during a telephone call.
Neoadjuvant chemotherapy (NACT) is standard treatment for many triple-negative (TNBC) and HER2-positive breast cancer. Study showed about half of the biopsy-proven axillary disease will be eradicated by NACT and converted to ypN0 indicating the efficacy of systemic treatment in local disease control. According to current guidelines, all initial cN0 patients will undergo sentinel lymph node biopsy (SLNB) after NACT and further axillary dissection (ALND) if tumor residual is discovered after SLNB. Data suggest patients who underwent SLNB have a significantly higher rate of disability in the early post-operative period compared to patients who did not and the avoidance of SLNB might translate into a considerable reduction of physical and emotional distress. Recent studies revealed the association between breast pCR and ypN0 status after NACT. Initially cN0 TNBC and HER2-positive breast cancer patients who achieve pCR in breast after NACT have a very low risk of positive lymph node residual and are very unlikely to benefit from further axillary surgery including SLNB. The investigators designed a clinical trial to test the hypothesis that selective omission of axillary surgery in distinct responders after NACT will not deteriorate survival. In the planned trial, axillary surgery will be completely eliminated for initially cN0 TNBC and HER2-positive breast cancer patients who achieve pCR in breast after NACT determined by lumpectomy. The trial is designed as a prospective, single-center, single-arm study with a limited number of patients (N=136). Patients will be recruited in China over a period of 36 months. Our results, together with other ongoing studies in other parts of the world with a similar design, might give practice-changing results and spare the time and the costs of a randomized comparison.
This is a randomized controlled trial that will evaluate the effectiveness two different outreach strategies for a population-based breast cancer screening program at the VA Puget Sound among average risk female Veterans who are due for breast cancer screening.
The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor. The reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date.
Study of NGM438 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors
This is a single arm, open-label, dose-escalation and dose-expansion phase I study evaluating A166 in patients with HER2-expressing locally advanced or metastatic solid tumors.
The purpose of this research study is to understand what effect near complete estrogen deprivation (NCED) therapy has on the heart in breast cancer patients. Investigators want to understand if NCED changes how the heart works.
In Italy, 50% of new breast cancer (BC) diagnosis occur in female of working age. Although return to work (RTW) is strongly desired by BC patients, cancer survivors are more likely to be unemployed than healthy individuals. Moreover, work difficulties may hindrance this process. Since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their RTW process. To date, the feasibility of the multidisciplinary vocational rehabilitation interventions has not been verified for BC patients.
Breast cancer (BC) have unmet needs that can impact negatively on participation in meaningful activities and the overall quality of life, if not addressed by the healthcare services. One of those needs is the return to work (RTW) for female in their working age. The perceived needs of BC patients and RTW process might be influenced by sociodemographic data, disease-related, and work-related factors. Moreover, needs might change (type and priority) from diagnosis onwards. Prospective data regarding these topics have never been collected in Italian BC patients.
In women with newly diagnosed breast cancer, synchronous contralateral breast cancer is reported in 1% to 3%. During the initial diagnosis of breast cancer, it is important to detect the contralateral cancer to avoid second round of cancer therapy. Because breast MRI is a highly sensitive modality, it is used for screening of occult contralateral disease in women newly diagnosed with breast cancer and detects contralateral cancers not seen on clinical or conventional imaging (mammography and ultrasonography) in 4.1% of women. However, the use of breast MRI for screening contralateral breast cancer, is limited not only by high costs and long examination time but also by high false-positive findings resulting in more benign biopsies and extensive surgeries. In addition, the use of intravenous gadolinium-based contrast agent is contraindicated in pregnancy and in women with renal impairment or contrast material allergy contrast. Thus, there is a need to develop a more safe and cost-effective supplemental imaging modality for screening breast cancer. Diffusion-weighted (DW) MRI is a fast, functional modality that measures the movement of water molecules to create tissue contrast without the need for contrast injection. Breast malignancies exhibit hindered diffusion and appear hyperintense on DW MRI with low apparent diffusion coefficient (ADC) compared to normal surrounding tissue. A number of studies have shown that the use of DW MRI can significantly reduce the false positives and unnecessary benign biopsy of breast MRI. Several studies have explored how to use DW MRI as a stand-alone tool for breast cancer screening, and recent results have shown that DW MRI is more useful than conventional imaging in detecting small breast cancer. However, most of these studies were retrospective with inconsistent results. Thus, a prospective multicenter study with standardized acquisition and interpretation protocols in a large population is needed to determine the efficacy of DW MRI for breast cancer screening. The purpose of our study is to determine whether DWI improves the performance of preoperative DCE MRI in detecting clinically occult contralateral breast cancers.