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Breast Neoplasms clinical trials

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NCT ID: NCT04354233 Recruiting - Clinical trials for Metastatic Breast Cancer

A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer

ABLE02
Start date: June 24, 2020
Phase: N/A
Study type: Interventional

INTRODUCTION: Patients with a metastatic breast cancer suffer from a deteriorated quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program based on connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer. METHODS/ANALYSIS: ABLE02 is a prospective, multicenter, randomized, controlled and, open-label study. 244 patients with a metastatic breast cancer , at least one positive hormone receptor and a first-line chemotherapy planned will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 hours a day during the whole intervention (6 months) with at least three walking sessions weekly and quizzes to answer each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application. DISCUSSION: An activity program based on smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors.

NCT ID: NCT04353557 Recruiting - Breast Cancer Clinical Trials

ctDNA Monitoring in Early Breast Cancer

Start date: November 29, 2019
Phase:
Study type: Observational

This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.

NCT ID: NCT04352777 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer

Start date: September 14, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to perform an in depth analysis of changes in the tumor immune microenvironment in patients undergoing treatment with standard of care endocrine therapy and abemaciclib in the advanced setting via singe cell RNA sequencing. The investigators will also correlate changes in serum estrogen levels to changes in tumor and peripheral immune cell repertoire and function (including regulatory T cell populations, B cells, myeloid-derived suppressor cell populations, T cell activation and T cell exhaustion).This study has two cohorts with 15 patients in each cohort.

NCT ID: NCT04352530 Completed - Obesity Clinical Trials

Culturally Appropriate Nutrition Communication for Mexican American Women

Start date: March 25, 2019
Phase: N/A
Study type: Interventional

A randomized controlled trial to test the effects of culturally appropriate nutrition communication for Mexican American women.

NCT ID: NCT04351230 Withdrawn - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer

Start date: November 11, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well T-DMI with or without abemaciclib works for the treatment of HER2-positive breast cancer that has spread to other places in the body (metastatic). T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers DM1 to kill them. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and abemaciclib may work better in treating patients with breast cancer compared to T-DM1 alone.

NCT ID: NCT04351139 Completed - Gynecologic Cancer Clinical Trials

Impact of the COVID-19 Pandemic in Gynecological Oncology

COVID-GYN
Start date: May 6, 2020
Phase:
Study type: Observational

The current infection with the Coronavirus SARS-CoV-2 (COVID-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. Data from the literature suggest that infection with Coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. In addition, the risk of infection would be 3 times greater in case of cancer. Faced with the COVID-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (CPR, teleconsultation, adaptation of treatment or even postponement of treatment). The objective of the High Council of Public Health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). This must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. The hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. Despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.

NCT ID: NCT04350398 Completed - Clinical trials for Breast Cancer Female

Rehabilitation Through Hippotherapy for the Management of Women After Primary Treatment of Breast Cancer

HippoBreastCa
Start date: April 20, 2017
Phase: N/A
Study type: Interventional

Breast cancer is the most common women's cancer and the third leading cause of death. Advances in prevention, detection and primary treatment have improved overall survival leading to its growing acceptance as a long-term disease. Following the announcement of breast cancer, but also after primary treatment, some symptoms appear directly compromising psychic and physical spheres. Hippotherapy is an emerging specialized rehabilitation approach performed through specially trained horses by accredited health professionals. The proposed hippotherapy program offers key elements for physical, psychic and social reinforcement, complementing conventional care. The aim is to provide patients with tools to consolidate their self-awareness and thus strengthen their ability to cope with the disease.

NCT ID: NCT04350229 Completed - Breast Cancer Clinical Trials

Endocrinological Changes Due to Pre-medications of Chemotherapy in Patients With Breast Cancer

ALTEDEXAMAMA
Start date: March 27, 2020
Phase: N/A
Study type: Interventional

Treatment for patients with high-risk breast cancer diagnoses is based on chemotherapy drugs with side effects. Dexamethasone is a drug that is part of the arsenal of pre-chemotherapy medications to prevent adverse events resulting from treatment, however common endocrine pathological conditions resulting from high doses of this corticoid are clinically evident in these individuals. The aim of this study is to evaluate the omission of corticosteroid doses as a pre-medication in cancer treatment after the second week of treatment with taxane in a curative setting.

NCT ID: NCT04350021 Completed - Chemotherapy Effect Clinical Trials

Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer

METRO
Start date: March 1, 2019
Phase:
Study type: Observational

Low dose metronomic chemotherapy (LDMC) in patients with metastatic breast cancer (MBC) is used as a palliative regiment with the aim to prolong and improve quality of life. The effect of LDMC is not fully elucidated. The aim is to evaluate the effect of LDMC with Capecitabine and Cyclophosphamide (CX) and to discover new potential predictive markers and potential markers for monitoring treatment effect.

NCT ID: NCT04348955 Completed - Clinical trials for Breast Neoplasm Malignant Female

Interest of Touch-massage in Hospital Day Care

TOMAS
Start date: October 7, 2019
Phase:
Study type: Observational

In spite of progresses made in the medical and nurse announcement (linked to the cancer plan), still a lot of patients fell lost, anxious, especially during the first venue at the hospital day care for their chemotherapy. A longer time is necessary to give them again explanation, to reassure and to listen to them. However, patients are not always in ability to hear due to their psychological status. Young women seem to be more in distress, this is linked to the fear of the disease, the change of their social status and the future of their children. It must be noted that there is an increase of complementary therapies including Touch-Massage. Studies showed its interest on quality of life, anxiety, pain and fatigue. The concept Touch-massage (TM) is defined as a benevolent concern that takes shape through the touch and the sequence of gesture on all or parts of the body. This allows to calm, to relax, to get back into shape, to reassure, to communicate or simply to provide well-being, enjoyable to receive and to practice. This treatment is already offered to the patients at the ICO, in priority while the first course of chemotherapy, but in an informal way. I has been noticed a better-being after the TM, and an increase of demand from the patients. This is why it would be interested to measure the evolution of quality of life of those patients having a chemotherapy for a breast cancer getting or not a TM.