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Breast Neoplasms clinical trials

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NCT ID: NCT04172597 Terminated - Breast Cancer Clinical Trials

A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies

Start date: December 23, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.

NCT ID: NCT04172350 Recruiting - Surgery Clinical Trials

An Innovative Care-improvement Smartphone-based Perioperative Solution for Women Undergoing Breast Cancer Surgery

iCareBreast
Start date: November 19, 2019
Phase: N/A
Study type: Interventional

This study aims to develop a mobile app-based periopeartive intervnetion for women undergoing breast cancer surgery and examine the effectiveness of the program on participants' health outcomes of self-efficacy, anxiety and depression, pain and fatigue, quality of life, and satisfaction with perioperative care. This study also aims to explore the perceptions of participants on strengths and weaknesses of using the app.

NCT ID: NCT04172259 Active, not recruiting - Breast Cancer Clinical Trials

ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC

Start date: January 10, 2019
Phase: Phase 2
Study type: Interventional

Breast cancer is the most common malignant tumor in women. EC-TH is one of the standard chemotherapy regimens for HER-2 positive early breast cancer(EBC). Earlier use of trastuzumab may improve DFS rate. In this study, the investigators want to find out whether ACH-TH regimen compared with the EC-TH regimen in HER2+ EBC could improve the pCR rate in neoadjuvant chemotherapy. We update protocol in Sep 2020, because Pertuzumab is approveled by Chinese goverment and coverd by national insurance, dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients.

NCT ID: NCT04172220 Completed - Clinical trials for Breast Cancer Female

Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

Start date: October 31, 2019
Phase: N/A
Study type: Interventional

The Neutrophil to Lymphocyte Ratio (NLR) is a frequently used biomarker of the systemic inflammatory response and is considered one of the most sensitive markers of inflammation. Many studies have documented the association between the use of opioid drugs in the acute phase -as it can be considered the use during general anesthesia- and the increase of the NLR value. Such increase could determine a temporary phase of immunodepression in the immediate post operative period with consequent increase of the inflammatory state. This study intends to assess whether different anesthetic techniques can be associated with different variations of the intra-patient NLR value between pre- and post-surgery. Patient will be randomized to receive either local regional anesthesia protocols with thoracic wall blocks (PEC I and serratus plane block) associated with opioid-free general anesthesia (PECS + Opioid-free GA) or general anesthesia.

NCT ID: NCT04170920 Completed - Breast Cancer Clinical Trials

Pilot Study of a an App to Improve Medication Adherence in Breast Cancer Survivors Receiving AIs

Start date: February 17, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility of an mobile-health strategy to improve patient-reported symptoms, promote life-saving medication adherence, and encourage healthy lifestyle behaviors in early stage breast cancer survivors receiving adjuvant Aromatase inhibitors, while beginning to predict psycho-social and demographic characteristics of those who benefit most from this approach. This will provide preliminary experience and evidence for larger, randomized clinical trials evaluating this methodology, which will have immediate and scalable influence on cancer survivor ship.

NCT ID: NCT04170595 Recruiting - Clinical trials for HER2-positive Breast Cancer

Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection

Start date: March 28, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody for injection for the treatment of HER2-positive breast cancer patients.

NCT ID: NCT04170465 Completed - Clinical trials for Breast Cancer Female

Role of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO)

METNEO
Start date: October 29, 2019
Phase: Phase 2
Study type: Interventional

Metformin, the widely prescribed oral hypoglycemic drug, is well known for its established efficacy, favorable safety profile, and low cost. Metformin has recently received increasing attention because of its potential antitumorigenic effects that are thought to be independent of its hypoglycemic effects. It has been extensively studied in preclinical models, which have implicated several molecular pathways in its antitumor activity. Metformin was proved to have anti-proliferative and apoptotic effects on tumor cells.Moreover, metformin enhances the T-cell mediated immune response to tumor tissue and fights metastases. Also, epidemiological studies have shown that metformin, but not other antidiabetic drugs, reduces cancer incidence and improves survivability in diabetic cancer patients. The proposed research in this application will investigate two prime questions with regards to the combined use of metformin together with traditional neoadjuvant chemotherapy in breast cancer patients. First, the hypothesis that the simultaneous use of metformin along with doxorubicin/cyclophosphamide/paclitaxel neoadjuvant protocol produces better antitumor outcomes will be tested. Second, the study will examine if the improved apoptotic effect of such regimen is paralleled by exaggerated stimulatory influences on apoptosis biomarkers.

NCT ID: NCT04170335 Withdrawn - Breast Cancer Clinical Trials

Effects of Bariatric Surgery on Breast Density Improvement and Impact on Breast Cancer Risk in Severe Obese Patients

Start date: February 22, 2021
Phase:
Study type: Observational

Breast cancer is the most common cancer in women in the US, and obese women have a 20% to 40% increase in the risk of developing breast cancer compared with normal-weight women. Bariatric surgery is now considered the first line option for weight loss management in morbidly obese patients with failure of medical treatment. There is strong evidence that in early stages of cancer the breast undergoes inflammatory and subsequently density changes that are observable in mammography. The aforementioned alterations have been suggested to be magnified by obesity, potentially due to its pro-inflammatory state. The investigators hypothesized that rapid weight loss following bariatric surgery and henceforth the reduction of inflammatory stress in the breast tissue could potentially have a positive effect in improving breast density and consequently, reducing the risk of breast cancer. In this order of ideas, with this study, the investigators aim to evaluate how breast density is modified after bariatric surgery, and how it impacts the risk of developing breast cancer using The Breast Cancer Surveillance Consortium (BCSC) risk score and calculator in our population.

NCT ID: NCT04169542 Recruiting - COVID-19 Infection Clinical Trials

Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery

Start date: May 21, 2019
Phase:
Study type: Observational

This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.

NCT ID: NCT04168957 Terminated - Breastcancer Clinical Trials

An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007

Start date: October 25, 2017
Phase: Phase 1
Study type: Interventional

KX-ORAX-008 is an extension study of patients who completed KX-ORAX-007 without disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and who wish to continue Oraxol treatment.