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NCT ID: NCT03556813 Not yet recruiting - Breast Cancer Clinical Trials

Artificial Intelligence vs Physicians for Breast Cancer Patients' Information

Start date: September 2018
Phase:
Study type: Observational

Chatbots (contraction of "chat" and "robot") are a computer software program that use statistical learning and aim to simulate a conversation by text or voice message. The use of these chatbots was evaluated as part of the increase in therapeutic adherence and information on well-being and mental health. In clinical studies, chatbots are useful in gathering information through questionnaires directly submitted during conversations or through keyword analyzes. There is no longer any delay between the moment the patient notices a side effect, for example, and the moment when the patient announces it during a consultation. The responses given by the chatbot do not constitute medical advice and only provide information on the treatments envisaged or in progress in the context of the management of breast cancer. The main objective of the study is to show that the chatbot Vik's answers to the common questions asked by breast cancer patients about their therapeutic management are at least as satisfactory as answers given by a committee of multidisciplinary doctors

NCT ID: NCT03546686 Not yet recruiting - Breast Cancer Clinical Trials

Peri-Operative Ipilimumab+Nivolumab and Cryoablation Versus Standard Care in Women With Triple-negative Breast Cancer

Start date: July 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the impact of peri-operative cryoablation, ipilimumab and nivolumab versus standard pre-operative care on 3-year Distant Disease-Free Survival (DDFS), in women with residual hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after taxane-based neoadjuvant chemotherapy.

NCT ID: NCT03543072 Not yet recruiting - Breast Cancer Clinical Trials

A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Breast Cancer Patients

Start date: June 15, 2018
Phase:
Study type: Observational

Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. It is a multicenter prospective observational study. We collect the basic information, medical history, chemotherapy-related adverse reactions, and the results of blood lipid and bone density test before, during and after adjuvant or neoadjuvant chemotherapy. The purpose of the study is to investigate the risk factors for hyperlipidemia, cardiovascular disease, and osteoporosis in postmenopausal breast cancer patients before and after chemotherapy, and to assess the risk of future arteriosclerotic cardiovascular disease and osteoporotic fractures. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.

NCT ID: NCT03543059 Not yet recruiting - Breast Cancer Clinical Trials

A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Premenopausal Breast Cancer Patients

Start date: June 15, 2018
Phase:
Study type: Observational

Breast cancer is one of the most common malignant tumor in women. About 60% of breast cancer patients are still in premenopausal status at the time of diagnosis in China. It is a multicenter prospective observational study. We will collect basic information, medical history, chemotherapy-related adverse reactions, and the results of hormone, blood lipid, and bone density test before, during and after adjuvant or neoadjuvant chemotherapy. The aim of the study is to evaluate the effect of chemotherapy on ovarian function and fertility and the protective effect of GnRHa. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.

NCT ID: NCT03530696 Not yet recruiting - Breast Cancer Clinical Trials

T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

T-DM1
Start date: August 31, 2018
Phase: Phase 2
Study type: Interventional

This is a randomized phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival compared to single agent T-DM1in patients with metastatic HER2 positive breast cancer

NCT ID: NCT03529383 Not yet recruiting - Breast Cancer Clinical Trials

Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer

DISCO
Start date: May 2018
Phase: N/A
Study type: Interventional

The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

NCT ID: NCT03529110 Not yet recruiting - Breast Cancer Clinical Trials

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane

Start date: August 10, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

NCT ID: NCT03523585 Not yet recruiting - Breast Cancer Clinical Trials

DS-8201a Versus Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Pretreated With Prior Standard of Care

Start date: August 2018
Phase: Phase 3
Study type: Interventional

The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T DM1.

NCT ID: NCT03523572 Not yet recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan (DS-8201a) With Nivolumab in Advanced Breast and Urothelial Cancer

Start date: May 2018
Phase: Phase 1
Study type: Interventional

The purpose of this phase 1b study is to test the combination of an experimental drug known as DS-8201a given along with Nivolumab (a marketed drug) in participants with HER2-expressing breast and urothelial cancer who had disease progression during or after prior therapies, did not respond to standard therapies, or for whom no standard therapy is available. The study will be performed in 2 parts. - Part 1 is to look at different doses of DS-8201a when given along with a fixed dose of nivolumab, and establish the most effective and safe dose (maximum/recommended tolerated dose) when used in combination with nivolumab. - Part 2 is to understand the positive or negative effects of this dose combination on the participant's body and disease. The study will also determine the pharmacokinetics of DS-8201a when administered with nivolumab.

NCT ID: NCT03523546 Not yet recruiting - Breast Cancer Clinical Trials

Oncology Episode Payment Model in Hawaii

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

The Oncology Episode Payment Model (EPM) is a payment model designed to test the effects of better care coordination on health outcomes and costs of care for Hawaii Medical Services Association (HMSA) members with cancer who receive chemotherapy.