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Breast Cancer clinical trials

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NCT ID: NCT05498155 Active, not recruiting - Breast Cancer Clinical Trials

Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer

OlympiaN
Start date: November 7, 2022
Phase: Phase 2
Study type: Interventional

This study to learn more about olaparib and olaparib plus durvalumab combination therapy and also to better understand the studied disease, breast cancer, and associated health problems. Olaparib is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. Olaparib is also approved by US Food and Drug Administration (FDA), European Medicines Agency (EMA) and in other countries for treating women with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. Durvalumab is a type of anticancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. Your immune system can then attack and kill the cancer cells. Durvalumab is approved by the FDA and the EMA for the treatment of patients with locally advanced non-small cell lung cancer after receiving chemoradiation therapy and extensive-stage small cell lung cancer in combination with chemotherapy. Some parts of this study are experimental, which means that durvalumab and the combination of olaparib and durvalumab are still in the development stage for the treatment of breast cancer, and they are not approved for treatment of breast cancer, except for use in research studies like this.

NCT ID: NCT05474391 Active, not recruiting - Breast Cancer Clinical Trials

MammaPrint Value for Pre-menopausal Breast Cancer Patients

Start date: July 15, 2022
Phase:
Study type: Observational

Nearly 200 cases are to be enrolled. The information of patient age, histologic grade, tumor size, ER and PR status, Ki-67 index, surgery mode should be provided. The adjuvant therapy regime (chemotherapy: none, TC*4, TC*6 or EC-T; endocrine therapy: TAM, OFS+TAM, OFS+AI) will be compared before and after MammaPrint testing. About 20 clinical staffs are enrolled to participate in this survey for the clinical decision making. Each case could be chosen five times at random.

NCT ID: NCT05459454 Active, not recruiting - Breast Cancer Clinical Trials

A Digital Solution for Breast Cancer Patients

Start date: July 15, 2022
Phase: N/A
Study type: Interventional

Sidekick Health has developed an interactive digital health program (SK-421) to support breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group aiming to recruit 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment. This pilot study will determine whether the digital health program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population. Patients will be randomized to receive either the standard of care (SoC) treatment alone or SoC with the addition of the digital healthprogram.

NCT ID: NCT05453604 Active, not recruiting - Breast Cancer Clinical Trials

Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications

URODETECT-WP1
Start date: June 18, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate and optimize protocols for the isolation and analysis of analytes in urine (cell-free nucleic acids, extracellular vesicles and proteins). The following factors will be evaluated (1) volumetric collection with Colli-Pee®, a collection device developed by Novosanis for standardized collection of urine, and (2) stabilization methods. This is a prospective study in which urine samples will be collected from healthy volunteers, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in different pilot studies for the protocol optimization. For the pilot study where the effect of volume will be assessed, participants will be requested to collect multiple samples with different Colli-Pee® variants and fill out questionnaires accordingly.

NCT ID: NCT05448963 Active, not recruiting - Breast Cancer Clinical Trials

Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy

Start date: July 30, 2022
Phase: N/A
Study type: Interventional

Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer. Robot-assisted mastectomy enables removal of the whole breast tissue with well-preserved breast skin envelope through a single longitudinal incision in the anterior axillary line at the nipple areolar level. The next-generation robot, da Vinci SP system, is single-armed, equipped with multiple flexible instruments and camera, which is likely to improve the efficacy of robotic mastectomy. The investigator's scope of this study is to establish the feasibility and safety of SP-applied NSM through this single-armed pilot trial. Participants with breast cancer indicated for nipple-sparing mastectomy or candidates of prophylactic mastectomy carrying germline pathogenic or likely pathogenic BRCA1/2 mutations are recruited to receive SP-assisted unilateral or bilateral NSMs. Immediate breast reconstruction is followed according to the mode of the plastic surgeon's clinical decision. The primary endpoint is technical feasibility, and the secondary endpoint is safety and patient-reported outcome.

NCT ID: NCT05441943 Active, not recruiting - Breast Cancer Clinical Trials

Lymphaticovenous Anastomosis as Treatment for Lymphedema

Start date: May 11, 2022
Phase: N/A
Study type: Interventional

The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery.

NCT ID: NCT05441722 Active, not recruiting - Breast Cancer Clinical Trials

CIPN in Early Stage Breast Cancer Patients

Start date: May 26, 2022
Phase: N/A
Study type: Interventional

Chemotherapy uses anti-cancer drugs to destroy cancer cells and is a common treatment for many cancers. Taxanes are the most widely used chemotherapy drugs given to breast cancer patients. However, taxanes also have toxic side effects. One of the most severe side effects is damage to nerves in the peripheral nervous system; a neurological disorder known as peripheral neuropathy. Common symptoms of peripheral neuropathy are pain, numbness, and tingling in the hands and feet, which can lead to chemotherapy being prematurely discontinued. Unfortunately, treatment options to manage peripheral neuropathy are limited. Exercise has recently been proposed to reduce symptoms, but consistently exercising during chemotherapy is challenging for patients because of treatment-related side effects and fatigue. A more feasible approach may be to exercise on the day before each infusion. This research includes two linked studies that aim to evaluate whether measuring peripheral nerve function at various timepoints throughout chemotherapy and performing aerobic exercise 24 hours before each infusion is feasible and acceptable to patients. In study 1, the investigators will recruit early stage breast cancer patients, who are scheduled to receive taxanes, from medical oncology outpatient clinics. The investigators will ask consenting participants to make 4 or 5 separate visits to the Hospital at various timepoints throughout chemotherapy, depending on the type of chemotherapy they are prescribed. Each study visit will involve completing some questionnaires as well as tests of peripheral nerve function and functional ability. In phase 2, a new cohort of breast cancer patients undergoing the same chemotherapy regimens will be randomly allocated to an exercise group or a control group. The exercise group will be invited to perform a supervised bout of aerobic exercise (30 min of moderate-intensity on a cycle ergometer) one day before they receive chemotherapy. The findings will lay the foundations for future large-scale research.

NCT ID: NCT05433480 Active, not recruiting - Breast Cancer Clinical Trials

A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

Start date: May 25, 2022
Phase: Phase 3
Study type: Interventional

This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advanced,recurrent or metastatic breast cancer with disease progression following endocrine therapy.

NCT ID: NCT05409664 Active, not recruiting - Breast Cancer Clinical Trials

Moving Forward Together 4

MFT4
Start date: November 10, 2022
Phase: N/A
Study type: Interventional

This is a 3-month physical activity intervention aimed to increase moderate-intensity activity among previously inactive breast cancer survivors. Participants will be eligible if they are not currently active, and have recently been diagnosed with breast cancer. Upon eligibility, participants will be randomized into one of two groups. The intervention group will receive weekly guidance from a peer coach to increase their activity throughout the three month intervention. The control group will be encouraged to self-monitor their physical activity throughout the three month intervention. Both groups will receive a Fitbit. Peer coaches will be trained to deliver the physical activity program using a web-based platform; all calls will be virtual. Participants will be assessed before and after the intervention.

NCT ID: NCT05402436 Active, not recruiting - Breast Cancer Clinical Trials

Breast Screening Atypia and Subsequent Development of Cancer in England

Start date: December 1, 2021
Phase:
Study type: Observational

During breast screening, atypical epithelial proliferations (atypia) can be detected. These are not cancer, but may mean that a woman is more likely to develop breast cancer in the future. This study explores how atypia develop into breast cancer in terms of number of women, time to cancer development, cancer type and severity, and whether this varies for different types of atypia. The results will be used to create new guidelines for how women with atypia should be followed up.