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Breast Neoplasms clinical trials

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NCT ID: NCT04389073 Recruiting - Clinical trials for Metastatic Breast Cancer

Safety and Efficacy of Toripalimab in HER2- Metastatic Breast Cancer Patients Treated With Metronomic Vinorelbine

Start date: April 1, 2020
Phase: Phase 2
Study type: Interventional

The investigators hypothesize that the administration of Toripalimab (anti-PD-1 antibody, JS001) combined to metronomic Vinorelbine may be an interesting therapeutic option for female patients with HER2- metastatic breast cancer. The approach suggested here is to deplete and active the immune response of these patients. The combination of Toripalimab and Vinorelbine would provide a higher gain in anti-tumor response in these patients than in those with chemotherapy alone. The investigators proposal is to conduct a multicentric, single arm, Phase II trial in HER2- patients with metastatic breast cancer, aiming to evaluate the clinical activity of the combination therapy Toripalimab + metronomic Vinorelbine. Patients will receive Vinorelbine (40 mg/day, tiw, per os) and Toripalimab (240 mg every 3 weeks, intravenously [IV]). The adverse events of the two drugs are well known.

NCT ID: NCT04388384 Active, not recruiting - Breast Neoplasm Clinical Trials

Real-life Pan-HER-blockade With Neratinib

ELEANOR
Start date: July 2, 2020
Phase:
Study type: Observational

So far, there is no data available on treatment of patients with early-stage hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified breast cancer, who completed adjuvant trastuzumab-based therapy less than one year ago, in the clinical routine setting. ELEANOR - designed as a prospective, longitudinal, non-interventional study (NIS) - will investigate real-world use of neratinib and its treatment management in patients with HR-positive, HER2-overexpressing/amplified breast cancer stage I-III having completed adjuvant trastuzumab-based therapy less than one year ago. Data from this study will contribute to a deeper understanding and characterization of the everyday use of neratinib in a broader patient population in the German and Austrian routine setting.

NCT ID: NCT04387630 Recruiting - Breast Cancer Clinical Trials

Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Start date: June 5, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.

NCT ID: NCT04386629 Completed - Breast Neoplasms Clinical Trials

Health Economy Register

GeRA
Start date: July 5, 2019
Phase:
Study type: Observational

In breast oncology, the increasing number of oral and intravenous drug therapies pose great challenges for patient management. Numerous studies demonstrate that well-informed patients develop higher confidence in their treatment and a greater sense of disease control, resulting in increased adherence and persistence as well as potentially better outcome. The electronic Patient Reported Outcome (ePRO) tool CANKADO is designed to help oncologists to fill the gap between good, personalized care and a time and resource-saving treatment for cancer patients. CANKADO helps patients and their physicians regarding therapy management by a standardized documentation procedure and, if needed, direct feedback to patients by the integrated Pro-React system. GeRA includes patients undergoing systemic therapy for breast cancer with access to CANKADO. The trial is based on questionnaires that are answered by patients via the CANKADO Patient App. Primary objective is to gain knowledge on the health economic impact of CANKADO resource utilization in breast cancer care including the evaluation of physicians' time and patient experience.

NCT ID: NCT04385433 Terminated - Breast Cancer Clinical Trials

A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer

PRAVAPREV-01
Start date: December 4, 2020
Phase: Phase 3
Study type: Interventional

-Interventional trials aim at preventing severe RIF occurrence in BC patients selected by individual radiosensitivity: PRAVAPREV-01 will be the first interventional double blind trial that will offer a personalised strategy to breast cancer patients who will be treated with adjuvant RT after breast conserving surgery: - By assessing individual risk of severe RIF development - By offering a statin targeted therapy to the high-risk patients identified.

NCT ID: NCT04383275 Recruiting - Breast Cancer Clinical Trials

Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)

IRIS
Start date: August 23, 2021
Phase: Phase 2
Study type: Interventional

This is an open label, phase II study evaluating the efficacy and safety of trastuzumab combined with oral chemotherapy or endocrine therapy in patients with HER-2 positive stage I breast cancer.

NCT ID: NCT04382352 Completed - Clinical trials for Metastatic Breast Cancer

B002 in Patients With HER2-positive Breast Cancer

B002-101
Start date: May 28, 2019
Phase: Phase 1
Study type: Interventional

To assess the safety and tolerability characteristics of B002 in patients with HER2-positive recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) was assessed and the maximum tolerated dose (MTD) was explored.

NCT ID: NCT04379908 Completed - Breast Cancer Clinical Trials

Healthy Lifestyles and Quality of Life in Women With Breast Cancer

Start date: November 7, 2017
Phase:
Study type: Observational [Patient Registry]

A cross-sectional, multicenter, and observational study designed to update clinical, pathological, and lifestyle information for a cohort of approximately 1245 breast cancer patients included in the epiGEICAM-01 study.

NCT ID: NCT04379570 Recruiting - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy

Start date: February 15, 2021
Phase: Phase 3
Study type: Interventional

This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.

NCT ID: NCT04379414 Recruiting - Breast Cancer Clinical Trials

YES Study - Newly Diagnosed/Metastatic Intervention

YES
Start date: September 16, 2020
Phase: N/A
Study type: Interventional

This research study is being done to monitor common symptoms and behavior, and to provide supportive care information and peer support, as well as research opportunities for young women ages of 18-39 years old who have been diagnosed with stage 0-IV stage breast cancer using a web-based portal (YES), built for smartphones, tablets, and computers.