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Breast Neoplasms clinical trials

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NCT ID: NCT04024267 Recruiting - Breast Cancer Clinical Trials

Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients

ERYT
Start date: March 10, 2020
Phase: N/A
Study type: Interventional

Cancer related fatigue (CRF) is the most burdening symptom in breast cancer patients, and prevalence exceeds 75% in patients with metastatic disease. CRF is described as the symptom that has the largest impact on quality of life, with negative effects on work, social activities, and daily activities, and may lead to treatment discontinuation. Currently, there is no gold standard for the treatment of CRF. Drug therapies are not satisfactory. Since physical activity is associated with significant reduction in CRF, patients are encouraged to engage in an at least moderate level of physical activity. However, for many metastatic breast cancer patients this is too burdensome. Finally, there is some evidence that non-pharmacological mind-body techniques may be beneficial in reducing CRF, yet the available data do not allow for final recommendations. Given the high prevalence of CRF and the substantial distress for patients, advancing treatment options for patients with CRF is highly desirable. In the present study, patients with metastatic breast cancer will be randomly assigned to two different non-pharmacological treatments for fatigue: Eurythmy therapy (ERYT), a standardized active mindful movement therapy, or a movement program without mindfulness features (CoordiFit). It will be tested, if ERYT has a superior benefit on fatigue compared to CoordiFit over the period of the intervention (20 weeks). Further, the benefit of ERYT on quality of life, sleep quality, anxiety, depression, pain, mobility of the arm, rate of return to work, compliance with ERYT, and targeted metabolomics will be investigated. Both groups will have equal frequency and duration of the training sessions. Each patient will receive 13 standardized therapy sessions of 45 min (once a week for 6 weeks and once every second week) during the total period of 20 weeks. The proposed study has been developed in the Breast Cancer Project Group of the Swiss Group for Clinical Cancer Research (SAKK) and is supported by many breast centers, because they realize that the patients value non-pharmacological treatment options and would be keen to participate in such a trial. If ERYT proves to be beneficial, the impact of this trial will be high and will have implications not only for metastatic breast cancer patients but also for other cancer patients, health care personnel, scientists and funding and regulatory bodies.

NCT ID: NCT04023292 Recruiting - Breast Neoplasms Clinical Trials

Comparative Study for the Degree of Biological Changes After Short-term 2 Weeks and 4 Weeks Preoperative Endocrine Therapy in Luminal Breast Cancer

Start date: July 2019
Phase: Phase 2
Study type: Interventional

RATIONALE: Estrogen can promote proliferation of tumor cells in hormone receptors (HR)-positive breast cancer. The standard therapy of Luminal subtypes is endocrine therapy, which can influence proliferation of tumor cells by blocking the use of estrogen by cancer cells or lowering the amount of estrogen the body makes. Thus, markers of proliferation are candidate markers of efficacy after short-term (e.g., 2 weeks or 4 weeks) preoperative hormone therapy. Ki-67 is most commonly used among these markers. In contrast to the absolute value, the degree of Ki-67 changes which consider the baseline values would be better to reflect the sensitivity of therapy. It is not yet known whether the degree of Ki-67 changes after 2 weeks or 4 weeks presurgery endocrine therapy is different and which interval is more suitable to assess therapy sensitivity. PURPOSE: This randomized phase II trial is studying to compare the degree of Ki-67 changes after 2 weeks or 4 weeks preoperative endocrine therapy and to determine a more appropriate interval to assess hormone therapy sensitivity in women who are undergoing surgery for HR-positive, Human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

NCT ID: NCT04023110 Active, not recruiting - Breast Cancer Clinical Trials

Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab

CCTGuide Pilot
Start date: August 9, 2019
Phase: Phase 1
Study type: Interventional

Investigators will evaluate the safety, tolerability, and feasibility of a risk-guided cardioprotective treatment strategy with carvedilol, as compared to usual care, in breast cancer patients undergoing treatment with doxorubicin, trastuzumab, or the combination.

NCT ID: NCT04022772 Completed - Breast Carcinoma Clinical Trials

Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer

Start date: July 31, 2019
Phase: N/A
Study type: Interventional

This trial studies the effect of an electronic health (eHealth) support program called PACK Health on patient reported health outcomes in patients with breast cancer. PACK Health monitors breast cancer patients' reported side effects and experience of care when receiving chemotherapy. Participating in the PACK Health coaching program may improve quality of life, decrease hospital admissions and improve overall health.

NCT ID: NCT04022616 Recruiting - Breast Cancer Clinical Trials

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Start date: June 4, 2010
Phase:
Study type: Observational

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

NCT ID: NCT04021069 Active, not recruiting - Breast Cancer Clinical Trials

Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

Start date: August 30, 2018
Phase:
Study type: Observational

This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.

NCT ID: NCT04020575 Recruiting - Clinical trials for Metastatic Breast Cancer

Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)

Start date: January 15, 2020
Phase: Phase 1
Study type: Interventional

Phase I/II study of adoptive immunotherapy for advanced MUC1* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which are specific for a cleaved form of MUC1 (MUC1*).

NCT ID: NCT04020523 Withdrawn - Breast Cancer Clinical Trials

Advanced MR Techniques for Breast Cancer Detection

RAPIDIRM
Start date: July 2019
Phase: N/A
Study type: Interventional

Evaluation of advanced MRI acquisition techniques (perfusion and diffusion) to detect breast cancer. Two MR advanced sequences will be added to a standard breast MRI protocol for evaluation purpose.

NCT ID: NCT04019678 Recruiting - Breast Cancer Clinical Trials

Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.

NEONOD2
Start date: June 21, 2019
Phase: N/A
Study type: Interventional

Italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative SLN (SLN ypN0) after NAC ,where the omission of axillary treatment is currently the standard treatment.

NCT ID: NCT04018235 Completed - Breast Cancer Clinical Trials

Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer

EORTCQLQBR45
Start date: June 14, 2019
Phase:
Study type: Observational

Females breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC QLG decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies. The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ- C30 in patients diagnosed with breast cancer. Participants will be enrolled in three groups according to their disease stage (1. localized disease or locally advanced disease, 2. metastatic disease, 3. follow up). Various combinations of therapies are permissible, resulting in a total of 17 subgroups.