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Breast Neoplasms clinical trials

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NCT ID: NCT06383026 Recruiting - Breast Cancer Clinical Trials

Transgender and Gender-Diverse Breast Cancer Screening Pilot

Start date: April 17, 2024
Phase:
Study type: Observational

This investigation is a prospective breast cancer screening study open to all transgender and gender-diverse persons (regardless of sex assigned at birth). Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with gender-affirming therapy and family cancer history and 2) investigate TGD persons perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening.

NCT ID: NCT06382948 Not yet recruiting - Clinical trials for Advanced Breast Cancer

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

ADELA
Start date: June 2024
Phase: Phase 3
Study type: Interventional

This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival. Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.

NCT ID: NCT06382441 Active, not recruiting - Behavior, Health Clinical Trials

A Tele-exercise Program for Breast Cancer Survivors

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The research protocol outlines a pilot study for a home-based and group-based tele-exercise program designed for breast cancer survivors. The study is a randomized controlled trial (RCT) led by Dr. Yang Gao from Hong Kong Baptist University, with multiple other investigators from Kwong Wah Hospital and the university itself. Breast cancer is identified as the most prevalent cancer among women globally and in Hong Kong. The document states that adjuvant therapies post-surgery, such as radiation and chemotherapy, can have both short-term and long-term side effects, which may affect the survivors' physical and mental health. The study is based on evidence that physical activity levels often decrease after a breast cancer diagnosis and that exercise can mitigate the side effects of treatment, improving health and quality of life. The pilot aims to test the acceptability and feasibility of a 12-week tele-exercise program that combines psychological theories and behaviour change techniques, transitioning from supervised to unsupervised exercise to build sustainable exercise habits. The study will enrol 24 patients, randomly assigning them to an intervention group or an active control group. The intervention group will receive 12 online training sessions plus 4 psychological counselling sessions, whereas the control group will receive educational essays on exercise and health. The training sessions for the intervention group will include various exercises with increasing intensity and duration over the 4 weeks, monitored by a pulse oximeter to ensure exercises are done at the appropriate heart rate. The sessions will be led by qualified coaches, with Dr. Gao overseeing quality control.

NCT ID: NCT06382142 Not yet recruiting - Clinical trials for Triple-Negative Breast Cancer

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

Start date: May 2024
Phase: Phase 3
Study type: Interventional

This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced or metastatic Triple-Negative breast cancer after taxane failure.

NCT ID: NCT06380816 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer

Start date: May 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells. The four main aims of the clinical trial are to find out: 1. The best dose of UCB4594 that can be given safely to participants in the trial. 2. What the side effects of UCB4594 are and how they can be managed. 3. What happens to UCB4594 inside the body and how it affects cancer cells. 4. Whether UCB4594 can cause cancer to shrink.

NCT ID: NCT06380803 Recruiting - Surgery Clinical Trials

Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence

ROMCAPO+AI
Start date: April 29, 2021
Phase:
Study type: Observational

The goal of this prospective study is to investigate the satisfaction, NASA-Task Load Index (TLX), and surgical proficiency of a robotic breast surgery education program using cadaver or porcine models, as well as to develop an AI-based surgical guide for utilization within the educational program in trainees for robotic breast surgery. The main question[s]it aims to evaluate : - Satisfaction questionnaire of a educational program - NASA-TLX of a educational program - global evaluative assessment of robotic skills (GEARS) of a robotic breast surgery for surgical proficiency Participants will participate the educational program and fill out a satisfaction questionnaire and NASA-TLX. The tutor evaluates GEARS for 15 minutes at the beginning and end of training. After the development of the surgical guide based on AI, researchers will compare a training group with or without surgical guide to see the effect of the surgical guide.

NCT ID: NCT06380751 Not yet recruiting - Clinical trials for Advanced Breast Cancer

Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

EvoPAR-BR01
Start date: April 18, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer.

NCT ID: NCT06379880 Recruiting - Breast Neoplasms Clinical Trials

Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution

FEGALA
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring.

NCT ID: NCT06378944 Recruiting - Breast Cancer Clinical Trials

Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer

INSEAN
Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.

NCT ID: NCT06378294 Recruiting - Breast Cancer Clinical Trials

Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA)

MACMA
Start date: April 20, 2021
Phase:
Study type: Observational [Patient Registry]

Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (IBC) patients undergoing upfront surgery. The ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (ALND) in early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial did not included patients treated with mastectomy, and the AMAROS trial only included 17% of mastectomy patients. The investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate.