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Breast Cancer clinical trials

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NCT ID: NCT05206396 Not yet recruiting - Breast Cancer Clinical Trials

TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients

Start date: March 2022
Phase:
Study type: Observational

Neoadjuvant systemic treatment for breast cancer (used in locally advanced and operable breast cancer) includes anthracycline based chemotherapy (Doxorubicin/Cyclophosphamide) followed by taxanes (weekly Paclitaxel or Docetaxel) with antiHer-2 Trastuzumab or dual antiHer-2 Trastuzumab plus Pertuzumab. Other regimens include Docetaxel plus Carboplatin plus Trastuzumab alone or combined with pertuzumab for Her-2 positive patients. The tumor microenvironment, which includes extracellular matrix and stromal cells, is a key factor in tumorigenicity and the prediction of the efficacy of immunotherapy, conventional chemotherapy, and other anticancer therapies. Tumor-infiltrating lymphocytes (TILs), one of the most important components of the tumor microenvironment, were reported to predict the response to NAC both for tumors and axillary lymph nodes in breast cancer patients. This study is conducted to examine the relationship between tumor-infiltrating lymphocytes (categorized into three levels) and the pathologic complete response to neoadjuvant systemic therapy in breast cancer patients, and to examine the relationship between TILs and 1-year invasive disease-free survival (IDFS).

NCT ID: NCT05206331 Not yet recruiting - Breast Cancer Clinical Trials

CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study

Start date: January 24, 2022
Phase: Phase 4
Study type: Interventional

One of the primary criticisms of mammography is that it leads to unneeded stress and anxiety from identification and biopsy of non-cancerous findings. Contrast-enhanced mammography (CEM) has the potential to significantly reduce biopsy rates for commonly seen benign breast lesions while preserving very high cancer detection. The investigators propose a prospective clinical study of patients with diagnostic mammograms rated as BIRADS 4A or 4B and scheduled for a biopsy, in which, prior to undergoing their scheduled biopsy, a CEM procedure is performed. The investigators will test the primary hypothesis that for soft tissue lesions (i.e. masses, asymmetries, architectural distortions) initially rated BI-RADS 4A/4B adding CEM will reduce, by at least 20%, the number of biopsy recommendations for actually benign cases and, at the same time, provide a negative predictive value (NPV) higher than 95%.

NCT ID: NCT05205200 Not yet recruiting - Breast Cancer Clinical Trials

Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)

Start date: February 1, 2022
Phase: Phase 2
Study type: Interventional

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

NCT ID: NCT05203445 Not yet recruiting - Breast Cancer Clinical Trials

A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer

Start date: January 14, 2022
Phase: Phase 2
Study type: Interventional

This study will test any good and bad effects of combining the study drugs pembrolizumab and olaparib, given before the standard surgical procedure, to treat TNBC or HR+ HER2- breast cancers. The study drugs could shrink cancer, but they could also cause side effects. The study researchers want to find out whether the study drugs will shrink the cancer by a certain percentage compared with its current size, which may improve the outcome of surgery.

NCT ID: NCT05198622 Not yet recruiting - Breast Cancer Clinical Trials

Can Chronic Post-surgical Pain be Reduced by Preserving Intercostobrachial Nerve During Axillary Lymph Node Dissection? : A Randomized Controlled Trial

PAINE
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Intercostobrachial nerve (ICBN) is a cutaneous nerve that provides sensation to the lateral chest, upper medial arm and axilla. It arises from the second intercostal nerve and leave intercostal space at the level of midaxillary line. It then pierces the serratus anterior muscle and enters axilla. Intercostobrachial nerve is encountered during axillary lymph node dissection (ALND) while mobilizing axillary contents laterally off the chest wall and tends to tether axillary contents to the lateral chest wall. Many surgeons routinely sacrifice it as doing so makes mobilization easier and allow exposure of long thoracic neve. Currently there is no consensus on the usefulness of preserving intercostobrachial nerve. According to a 2020 systemic review and meta-analysis, prevalence of CPSP/ PPSP following breast cancer surgery ranged from 2% to 78% and pooled prevalence was found to be 35%. Higher prevalence was associated with ALND. Several risk factors have been identified which contribute to the development of PPSP. These include; Preexisting pain, preoperative opioid exposure, genetics, psychological factors such as anxiety, depression or catastrophizing, intensity of acute postoperative pain and nerve injury during surgery. As a result of nerve injury, damaged and non-damaged nerve fibers start generating action potential spontaneously. These are considered ectopic inputs as they do not arise from peripheral terminals. These inputs lead to the development of central sensitization, which is a state of exaggerated functional response of neurons involved in the pain pathway. This increased sensitization results due to increased membrane excitability, enhanced synaptic efficacy and decreased inhibition. The aim of the present trial is to investigate the effect of ICBN preservation on chronic/ persistent post surgical pain (CPSP/ PPSP). This will be achieved through a randomized control trial with CPSP/ PPSP as a primary outcome measure. Secondary outcome measures will include Health Related Quality of Life (HRQoL), operating time, lymph node yield, functional status of ipsilateral shoulder, post-operative complications and post-operative use of opioid analgesics.

NCT ID: NCT05196269 Not yet recruiting - Breast Cancer Clinical Trials

Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.

CINDERELLA
Start date: June 2022
Phase: N/A
Study type: Interventional

Breast cancer is the most commonly diagnosed cancer, with an estimated 2.3 million new cases per year globally. Approximately 90% of these patients will undergo breast surgery with/without radiation (locoregional treatment). Different surgical techniques can be offered to the patient, each leading to completely different aesthetic outcomes. Moreover, for different patients, undergoing the same surgery, the aesthetic outcome could be completely different based on individual patient's factors (e.g, age, body habitus). In the CINDERELLA trial the investigators will be using the (Breast Locoregional (BreLO) AI system (an artificial intelligence-based tool for classification of aesthetic outcomes and matching data and photographs) integrated in CANKADO (a cloud-based healthcare platform) to create an easy-to-use application that can be used on any electronic device, to simulate visually to the patient the aesthetic outcome of a certain surgery or radiation treatment. In the CINDERELLA trial the investigators plan to compare if the application helped to fulfil the expectations and lead to better quality of life compared with the classical approach. In the classical approach (control arm) doctors usually propose a locoregional treatment and explain theoretically how the result will be. Nurses help by explaining further details about surgery and possible outcomes. In the majority of centers no photographic evaluation is done and expectations are not measured. The CINDERELLA trial will help to overcome any miscommunication and potential boundaries in patient's or physician's understanding of the potential outcomes of locoregional treatment of breast cancer.

NCT ID: NCT05196087 Not yet recruiting - Breast Cancer Clinical Trials

Non-Invasive Artificial Intelligence-Based Platform MonIToring Program (NIP IT!)

NIP IT!
Start date: March 2022
Phase:
Study type: Observational

Patients who have undergone curative treatment may be at risk of relapse. This study will collect, annotate, and sequence biospecimens (blood, stool, and tissue) from patients across different tumor types to detect molecular residual disease (MRD) before metastases become radiographically or clinically detectable. This will allow for early cancer interception, and hopefully prolong relapse-free survival across tumor types.

NCT ID: NCT05193149 Not yet recruiting - Breast Cancer Clinical Trials

Inspiratory Muscle Training in Obese Breast Cancer Survivors

IMOCS
Start date: December 1, 2022
Phase: N/A
Study type: Interventional

The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in stage 0-III obese breast cancer survivors. The investigators central hypothesis is that obesity promotes exercise intolerance via obesity-related impaired breathing mechanics and that inspiratory muscle training will be effective in improving impaired breathing mechanics and exercise tolerance..

NCT ID: NCT05192525 Not yet recruiting - Breast Cancer Clinical Trials

The Effects of a Nurse-led mHealth Program for Symptom Self-management of Breast Cancer Patients Undergoing Chemotherapy

mChemo
Start date: March 7, 2022
Phase: N/A
Study type: Interventional

Breast cancer (BC) survivors will experience multiple symptoms following chemotherapy. During the pandemic of COVID-19, the closure of clinics and fear of infection lead to BC patients' challenges in self-managing their multiple symptoms in home settings. Mobile health (mHealth), without time and space limitation, plays a positive role in supporting self-management and treatment compliance. However, previous mHealth self-management studies did not report sustained beneficial effects with physician-led supervision. In oncology practice, the nurse-led model of patient self-management for breast cancer has been placed on greater emphasis. Accordingly, an innovative nurse-led supervised mHealth program was designed to support self-management for BC patients undergoing chemotherapy. This pilot study aims to examine the feasibility and acceptability of a nurse-led mHealth-based self-management program for BC patients receiving chemotherapy, in order to provide evidence for conducting a definitive trial. The feasibility outcomes of the pilot study include subject eligibility rate, recruitment rate, and retention rate. The efficacy outcomes relate to self-efficacy (primary outcome), symptom distress and frequency, as well as health-related quality of life, and healthcare utilisation. The qualitative outcomes encompass patient- and provider-users' perceptions of the app usability and subjects' experiences of engaging in the pilot study.

NCT ID: NCT05191914 Not yet recruiting - Breast Cancer Clinical Trials

Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to CDK4/6 Inhibitors

Start date: February 7, 2022
Phase: Phase 4
Study type: Interventional

The trial used a multicenter, open, single-arm design in which patients were treated with Chidamide combined with Fulvestrant.The primary objective is to evaluate the preliminary efficacy and safety of Chidamide in combination with Fulvestrant.Patients included in the trial were advanced breast cancer progressing on first-line aromatase inhibitor + Cyclin-dependent kinases(CDK)4/6i rescue therapy.