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Breast Neoplasms clinical trials

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NCT ID: NCT04948983 Recruiting - Breast Cancer Clinical Trials

The Effect of a Patient Decision Aids for Breast Cancer Screening

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Breast cancer is one of the most common cancers in Chile. National efforts focus on early detection, offering universal access to breast cancer screening through mammography to women at risk age. However, 30% of women do not undertake the exam due to a lack of knowledge and anxiety when facing the decision. The aim of this study is to develop and evaluate the effectiveness of a decision aid (DA) for women facing breast cancer screening decision in the country. Methods: following the Medical Research Council guidelines for the development and implementation of a complex intervention in public health, the investigators have: 1) culturally adapted the German DA for mammography; 2) conducted focus groups with experts to further develop the DA; 3) pilot-tested the online DA with 20 women in primary care centres. A total of 3,269 women aged 50 to 69 years old are invited to join the study. The intervention group accesses a webpage, answers a set of questionnaires at baseline, and then the DA (developed according to the IPDAS recommendations). The Control group accesses a webpage, answers a set of questionnaires at baseline, and then receives standardised information given by the healthcare system. Both groups complete the questionnaires two weeks later. The primary outcome measure is an adapted and validated version of Informed Choice. Additionally, decisional conflict, anxiety, and screening undertake rate are measured. Multiple lineal regression analysis will be conducted.

NCT ID: NCT04947280 Recruiting - Breast Cancer Clinical Trials

Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer

Start date: January 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.

NCT ID: NCT04947189 Recruiting - Clinical trials for Triple Negative Breast Cancer

Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer

4CAST
Start date: November 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.

NCT ID: NCT04946864 Recruiting - Breast Cancer Clinical Trials

A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer

Start date: August 13, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, open-label, phase Ib/II study of APG-2575 as a single agent in patients with advanced solid tumors or in combination with anti-cancer agents such as CDK 4/6 inhibitor palbociclib in patients with ER+/HER2- metastatic breast cancer (mBC) who have progressed or relapsed after first line therapy

NCT ID: NCT04943497 Recruiting - Breast Cancer Clinical Trials

A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia

PROSPERITY
Start date: July 27, 2021
Phase:
Study type: Observational

This study is planned as a prospective multicenter NIS. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule. Patients with HR+/ HER2- advanced or metastatic BC that initiated treatment with ribociclib, alpelisib, mono endocrine therapy or chemotherapy will be included into the study across seven Russian districts.

NCT ID: NCT04941885 Recruiting - Breast Cancer Clinical Trials

Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer

Increase
Start date: June 25, 2021
Phase: Phase 2
Study type: Interventional

Antibody-dependent cell-mediated cytotoxicity (ADCC) is one of the important mechanisms for suppressing tumors of Trastuzumab. Pre-clinical data suggest that the ADCC effect of Inetetamab, an anti-HER2 monoclonal antibody with a modified Fc segment, is 1.11 times that of trastuzumab. Previous studies indicated that enhanced ADCC effects can be transformed into clinical benefits. Immune induction through cyclophosphamide metronomic chemotherapy may further enhance the ADCC effect of anti-HER2 monoclonal antibodies. Therefore, we conducted this study to explore the efficacy and the safety of Inetetamab combined with cyclophosphamide metronomic chemotherapy and aromatase inhibitors(AI) in the treatment of metastatic HER2-positive and HR-positive breast cancer patients and to explore the possible mechanisms.

NCT ID: NCT04937660 Recruiting - Clinical trials for Metastatic Breast Cancer

Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC

PRECIOUS
Start date: July 15, 2021
Phase:
Study type: Observational

The objective of this non-interventional multicenter study is to provide prospective, observational data on patients initiating treatment with palbociclib combination to contribute to the knowledge of HR+ HER2-metastatic/locally advanced Breast Cancer (BC) disease management, its treatment pattern, clinical outcomes and quality of life (QoL) in the routine clinical practice in Africa and Middle East countries .

NCT ID: NCT04937309 Recruiting - Breast Cancer Clinical Trials

Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea

SILENCE
Start date: June 24, 2022
Phase: N/A
Study type: Interventional

Despite pharmaceutical innovations, chemotherapy induced nausea is frequent and largely participating to alter our patients quality of life. Non invasive vagal stimulation is approved in other health issues, for example in headache or gastroparesis, with a reported benefit on nausea. This study aims to analyse if a non invasive vagal stimulation could better prevent chemotherapy induced nausea, in addition to standard treatment, in breast cancer patients treated with cyclophosphamide and anthracycline.

NCT ID: NCT04936295 Recruiting - Breast Cancer Clinical Trials

Fulvestrant Plus Anlotinib in HR(+)/HER2(-) Metastatic Breast Cancer With FGFR Mutation

Start date: June 16, 2021
Phase: Phase 2
Study type: Interventional

Previous studies have shown that the FGF signaling pathway is closely related to endocrine therapy resistance in breast cancer, but there is not sufficient evidence for the combination of endocrine therapy and FGFR inhibitors. Anlotinib is a highly effective VEGFRs, FGFRs, PDGFRs multi-target tyrosine kinase inhibitor. Therefore, we conducted this single-arm, single-center phase II clinical study to evaluate the efficacy and the safety of anlotinib combined with fulvestrant in patients with metastatic HR+/HER2- breast cancer patients with FGFR mutation and resistance to aromatase inhibitor therapy, to provide new treatment options for these patients.

NCT ID: NCT04934098 Recruiting - Breast Neoplasms Clinical Trials

Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

This is a randomized clinical trial with women with lymphedema secondary to breast cancer. The intervention will consist of the use of self-adjusting clothing versus compressive bandaging (routine treatment of the institution). Self-adjusting clothing is expected to be more effective for the treatment of lymphedema reduction, when compared to standard treatment, in addition to promoting a better quality of life and functionality.