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Breast Cancer clinical trials

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NCT ID: NCT04270136 Completed - Breast Cancer Clinical Trials

Feasibility of Total Mastectomy in Ambulatory Care

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

Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population. The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy. In France, Ambulatory care is developed as part of the new national health plan. Breast conserving surgery for tumorectomy or partial mastectomy is already done in outpatient vacation. Total mastectomy is an extension of this surgery, and, as such, underpins the investigator's hypothesis that total mastectomy is feasible in outpatient care .

NCT ID: NCT04270123 Completed - Breast Cancer Clinical Trials

An EORTC Study Updating the QLQ-BR23 to BR45

Start date: November 2, 2020
Phase:
Study type: Observational

Female breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC Quality of life group decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies. The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ-C30 in patients diagnosed with breast cancer. Participants will be enrolled in four groups according to their disease stage (1. local/locally advanced disease, 2. metastatic disease, 3. follow up. Various combinations of therapies are permissible. According to sample size calculations, we will include a total of N =490 patients from 12 countries. Participants will be invited to complete the QLQ-C30 and the QLQ-BC45, followed by the Debriefing Questionnaire. Data of all patients will be used to evaluate the scale structure, internal consistency, convergent and discriminant validity. A subgroup of follow up patients with no evidence of disease (no change in health status) will be invited to complete the QLQ-C30 and the QLQ-BC45 for a second time one to two weeks later for the test-retest analysis. A subgroup of patients from the local/ locally advanced breast cancer group (who have had change in disease or treatment status after the first assessment) will be invited to complete a second set of questionnaires for the response to change analysis. Sociodemographic and clinical data will be recorded using standardized case report forms (CRF).

NCT ID: NCT04268134 Completed - Breast Cancer Clinical Trials

Altering Lipids for Tolerance of Aromatase Inhibitor Therapy

ALTA
Start date: July 28, 2020
Phase: Phase 2
Study type: Interventional

Aromatase inhibitor medications have been approved by the U.S Food and Drug Administration (FDA) for treatment of hormone receptor positive breast cancer. This treatment has been shown to be very effective for treating breast cancer. However, some patients have difficulty tolerating the treatment, and some even decide to stop treatment because of the side effects. Research has shown that over half of patients who had joint pain and stiffness when taking an aromatase inhibitor had an improvement in their symptoms when they took omega-3 fatty acid supplements. This study is being conducted to test whether having patients start to take an omega-3 fatty acid supplement soon after they starting taking an aromatase inhibitor medicine will reduce the likelihood that they will have bothersome symptoms.

NCT ID: NCT04267900 Completed - Breast Cancer Clinical Trials

99mTc-HPArk2 SPECT/CT for the Detection of HER2-positive Breast Cancer

Start date: December 7, 2019
Phase: Early Phase 1
Study type: Interventional

This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-HPArk2 in breast cancer patients. A single dose of 11.1Mega-Becquerel (MBq) per kilogram body weight 99mTc-HPArk2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

NCT ID: NCT04262219 Completed - Breast Cancer Clinical Trials

Clinician Communication About Sexual Health

Start date: February 7, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to adapt a previously tested brief intervention aimed at enhancing clinicians communication about sexual health (iSHARE) to a mobile web-based platform showcasing a two-part podcast and to assess the feasibility, acceptability, and preliminary effects of the intervention in breast cancer clinicians.

NCT ID: NCT04261218 Completed - Breast Cancer Clinical Trials

Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of Tomivosertib Combined With Paclitaxel in Advanced Breast Cancer

Start date: August 25, 2020
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label trial to evaluate the safety, pharmacodynamics (PD), pharmacokinetics (PK), and efficacy of tomivosertib in combination with paclitaxel in patients with advanced breast cancer (ABC) of any subtype. The trial will enroll up to 45 patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 with any breast cancer (BC) subtype and at least one measurable lesion, for whom standard-of-care treatments are ineffective, not tolerated or were refused. All patients will be initially treated with tomivosertib for 14 days (referred as the run-in period). Once treatment samples are obtained, weekly paclitaxel will be added to the treatment regimen. Tumor assessments will be done at screening and then periodically throughout trial treatment. Patients will continue to receive trial treatment until progressive disease, as defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, intolerable trial-treatment-related toxicity, consent withdrawal, or other criteria is met (defined within the trial protocol).

NCT ID: NCT04260620 Completed - Clinical trials for Benign Breast Findings

Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

DMT SV RRS3
Start date: February 8, 2020
Phase:
Study type: Observational

The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. The reader study image case set will be enriched with cancer cases.

NCT ID: NCT04259905 Completed - Breast Cancer Clinical Trials

Pink Warrior 2: Teleconference-based Gaming Support

PW2
Start date: May 11, 2020
Phase: N/A
Study type: Interventional

Breast cancer survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decrease of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-only 1 in 3 survivors met physical activity recommendations of 150 minutes of moderate-intensity activity per week. Physical activity interventions have shown effectiveness in helping breast cancer survivors increase physical activity during treatment, but limited evidence-based physical activity interventions have been incorporated into the clinic and community. To address this limitation, the investigators are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior. The goal of this study is to compare an intervention that uses active games versus an intervention uses pedometer to encourage physical activity such as walking within breast cancer survivors in active cancer treatment. The study will include breast cancer survivor between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants will be randomized to participate in the support group using the active video game-based physical activity intervention (Wii and Xbox active games) or to participate in the existing UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators hypothesize that by engaging in active video gaming, breast cancer survivors will be motivated to initiate and maintain physical activity during treatment. This will ultimately increase functional capacity and prevent functional disability in breast cancer survivors.

NCT ID: NCT04259866 Completed - Clinical trials for Breast Cancer Screening

FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS

Start date: January 1, 2019
Phase:
Study type: Observational

To analyse false positives in breast cancer screening with tomosynthesis versus 2D mammography. The Avellino Breast Tomosynthesis Screening Trial is a observational population-based study that analyze souspicious findings in tomosynthesis slice images. This study is based on two years screening and tomosynthesis was analzyed by two expert breast radiologists.

NCT ID: NCT04258085 Completed - Breast Cancer Clinical Trials

Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System

Start date: July 1, 2020
Phase:
Study type: Observational

This observational study evaluates scale-up of a breast cancer early detection program in Rwanda that was initially piloted in a single district. Specifically investigators will examine patient volume, service delivery, loss-to-follow-up rates, and cancer detection rates noted following implementation of scale-up to 3 additional districts. For scaleup, breast cancer screening with CBE was added to a cervical cancer screening initiative, in a combined Women's Cancer Early Detection Program (WCEDP).