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Breast Neoplasms clinical trials

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NCT ID: NCT04177108 Completed - Clinical trials for Triple-Negative Breast Cancer

A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Start date: November 25, 2019
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

NCT ID: NCT04176848 Active, not recruiting - Breast Cancer Clinical Trials

CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer

Start date: December 19, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out the effect that CFI-400945 and durvalumab have on breast cancer.

NCT ID: NCT04176809 Recruiting - Breast Cancer Clinical Trials

Health-Related Quality of Life Coupled With Therapeutic Information on Compliance to Endocrine Therapy in Breast Cancer

COMPLIANCE
Start date: May 14, 2021
Phase: N/A
Study type: Interventional

Only 59% of women with breast cancer (BC) treated with Endocrine Therapy (ET) remain compliant one year upon initial prescription, despite its proven effectiveness in reducing recurrence and improving survival. Health-related quality of life (HRQoL) in BC has been widely studied and the positive effects of its routine evaluation on the improvement of communication between patients and medical staff and survival have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Since compliance is a multidimensional phenomenon, a multifaceted intervention is necessary to improve it. Thus, the investigators hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with delivery of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.

NCT ID: NCT04176757 Completed - Breast Cancer Clinical Trials

A Study of ZN-c5 in Participants With Breast Cancer

Start date: January 3, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer

NCT ID: NCT04176354 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy

Start date: January 25, 2019
Phase:
Study type: Observational

A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.

NCT ID: NCT04175821 Completed - Clinical trials for Late Effects of Hypofractionated Radiotherapy in Breast Cancer

Late-term Effects of Hypofractionated Chest Wall and Regional Nodal Irradiation in Patients With Breast Cancer

LEHR
Start date: January 1, 1990
Phase:
Study type: Observational

Survival of breast cancer patients has improved with multimodality treatment. Hypofractionated radiotherapy (RT) is rapidly emerging as one of the options for breast cancer patients after breast conservation surgery (BCS) but data on postmastectomy radiation therapy (PMRT) with hypofractionation is lacking and there is always concern for the late effects of RT especially with regional nodal irradiation (RNI). The potential survival benefits of locoregional radiation needs to be balanced with late-term effects. There is a dearth of data on RNI with hypofractionation. Therefore, reporting late-term effects of radiation in these patients is of utmost importance, especially with hypofractionation. Very few patients were given PMRT or RNI in the START trials, so definitive conclusions about the safety of shorter fractionation RNI cannot be drawn from these studies.1-3 There are also studies from Canada and the US with similar dose fractionations in the PMRT setting with limited number of patients but without RNI.4,5 There is a world-wide need for data on PMRT and especially with RNI for patients with breast cancer with its late-term consequences. Because of this, many radiation oncology societies are hesitant in recommending hypofractionated RNI. It is also an area for potential research in breast cancer radiotherapy. We have published our clinical outcomes with 3 weeks of adjuvant local and RNI with hypofractionation in the past.6-10 In this study, we will report late-term effects of PMRT and RNI with this schedule in patients with stage II and III breast cancer from a single institute from India which is practicing hypofractionation since 1976.

NCT ID: NCT04174391 Recruiting - Clinical trials for Malignant Tumor of Breast

Lifestyles and Breast Cancer

LifeBreast
Start date: May 29, 2020
Phase: N/A
Study type: Interventional

Background: In Spain, 1 out of every 11 women will have a breast cancer before the age of 85 years and breast cancer is the leading cause of potential years of life lost. The randomized intervention in PREDIMED trail, using Mediterranean diet with free provision of extra virgin olive oil (MedDiet+EVOO) dramatically and significantly reduced the occurrence of cases of postmenopausal breast cancer. Objectives: Assess the efficacy of a nutritional intervention with MedDiet+EVOO for the prevention of relapses among women with early breast cancer. Methods: Randomized, multicenter trial (LifeBreast) among 766 women diagnosed with early breast cancer. Participants will be randomized in a 1:1 ratio to i) MedDiet+EVOO or ii) low-fat diet. Changes in circulating tumor cells, inflammatory biomarkers, oxidative stress and quality of life will be evaluated. The intervention will be delivered by face-to-face interviews with study dietitian, phone calls, and online tools. Participants in the MedDiet+EVOO group will receive 0.5l/week of EVOO and participants in the low-fat group will receive allotments of different foods, both at no cost. Generalized estimating equations will be used to estimate between-group differences in the following outcomes: circulating tumor cells, inflammatory biomarkers, oxidative stress, and quality of life will be evaluated.

NCT ID: NCT04174352 Recruiting - ESR1 Gene Mutation Clinical Trials

FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer

Start date: October 20, 2020
Phase: Early Phase 1
Study type: Interventional

Despite broad advancements in endocrine therapy for ERα+ breast cancer, resistance ultimately develops. A common driver of resistance are known ESR1 mutations that lead to constitutively active receptor signaling and transcriptional regulation that is always "turned on" despite the absence of estrogen. Patients with ESR1 mutations are expected to have decreased binding affinity for tamoxifen and thus may be underdosed on standard therapy. [18F]-fluoroestradiol Positron Emission Tomography/Computed tomography (FES-PET/CT) imaging is a novel functional imaging technique that can non-invasively measure ERα expression and inhibition in metastatic ERα+ breast cancer. The proposed a pilot study uses FES-PET/CT imaging to measure ERα blockade to determine the optimal dose of tamoxifen in patients with ESR1 mutations.

NCT ID: NCT04174248 Completed - Breast Cancer Clinical Trials

Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life

Start date: January 11, 2019
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the quality of life (QoL) for women with breast cancer in Taiwan after using the BCSMS App.

NCT ID: NCT04173897 Completed - Clinical trials for Metastatic Breast Cancer

Living Better With Advanced Breast Cancer: Feasibility Evaluation of an Online Supportive Intervention.

LIBERATE
Start date: June 6, 2020
Phase: N/A
Study type: Interventional

The LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Overall, this intervention aims to improve quality of life among this growing group of patients through targeted, tailored and accessible information and support. This randomised waiting list control trial aims to evaluate the feasibility of the clinically integrated LIBERATE intervention. Results of participants' online symptom monitoring questionnaires are integrated with their electronic patient record, enabling clinician review and follow up alongside participants' own self-management activities.