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156 active trials for Breast Neoplasms

PI-targeted PNE+MI Compared to BIOMEDICAL Education in BCS

Breast cancer is the most frequently diagnosed cancer in women worldwide. An important portion of the breast cancer survivors will face chronic pain complaints. These pain complaints do not only impact the patient's quality of life but also prevents resumption of activities, leading to huge economic costs. 30% of all breast cancer survivors with pain present with perceived injustice which has been conceptualized as a multidimensional appraisal process characterized by a tendency to interpret one's losses as severe and irreparable, to attribute blame to others for one's suffering and to experience a sense of unfairness. Perceived injustice is also associated with increased opioid prescription and use, urging the need for targeted interventions to diminish perceived injustice. Despite the fact that specific treatment plans for perceived injustice are not yet proven, pain neuroscience education (PNE) is proven to reassure and encourage towards activity. In order to obtain the targeted behavioural change, motivational interviewing (MI) is used as the communication process throughout PNE. A multi-centre, parallel, two-arm, investigator-blinded study with 4-weeks intervention and two years follow-up will be conducted in 156 BCS with PI and pain. These will be randomly assigned to the intervention or usual care group. The groups will receive 1 online session, an information leaflet and 3 live sessions of education spread over 4 weeks. Pain neuroscience education in combination with motivational interviewing will be given in the experimental group and biomedically-focused education to the control group. The primary scientific objective of the study is to examine whether perceived injustice-targeted PNE is superior to biomedically-focused pain education in reducing pain after 12 months in breast cancer survivors with perceived injustice and pain. The secondary objectives of the study are to examine whether perceived injustice-targeted PNE, compared to biomedically-focused pain education, results in improving health-related quality of life, reducing perceived injustice and opioid use after 24 months in breast cancer survivors with perceived injustice and pain, and to conduct a health-care cost analysis which will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in breast cancer survivors with perceived injustice and pain.

Start: April 2021

PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors

A Phase 1 dose escalation and expansion study evaluating safety, tolerability and pharmacokinetics of PF-06952229 in adult patients with advanced solid tumors.

Start: October 2018

Vaccination of High Risk Breast Cancer Patients

Start: January 2015

Vaccination of Triple Negative Breast Cancer Patients

The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III triple negative breast cancer (TNBC). This study will compare the vaccine plus standard neoadjuvant chemotherapy and surgery to standard neoadjuvant chemotherapy and surgery alone.

Start: January 2019

CE-MRI&CESM in Solid Breast Lesions

Our study aimed to assess the accuracy of CE-SM in comparison to contrast-enhanced breast MRI in the evaluation of solid breast lesions.

Start: April 2021

Breast Cancer Endocrine Therapy FITness (BE-FIT) Trial.

This project will assess the efficacy of an 8-week virtual exercise program on physical function offered to those with a breast cancer diagnosis currently receiving endocrine therapy. The intervention includes twice-weekly virtual group exercise classes. Participants also complete one to three independent home exercise sessions per week throughout the intervention. Testing will occur virtually at baseline, 8-weeks (at end of program) and follow-up evaluations will be performed at 16-weeks and 12- months after baseline testing. Questionnaires will be administered through REDCap. Exercise sessions and testing will be administered virtually via Zoom.

Start: March 2021

Focused Ultrasound and Gemcitabine in Breast Cancer

This study will test the use of focused ultrasound ablation, low-dose gemcitabine (a chemotherapy) and the combination of focused ultrasound ablation plus low-dose gemcitabine in patients with early-stage breast cancers. We will be testing the effects of each of these regimens on cells in the immune system. We hypothesize that the combination of focused ultrasound ablation and gemcitabine will decrease myeloid-derived suppressor cells and will increase T cell activity. We also hypothesize that focused ultrasound ablation and low-dose gemcitabine will be safe and will result in non-inferior surgical completion rates and tumor margin assessments.

Start: June 2021

9-ING-41 in Patients With Advanced Cancers

GSK-3? is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3? inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.

Start: January 2019

A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)

This 2-part, Phase 1, open-label study will determine the recommended Phase 2 dose (RP2D) of ARX788 in subjects with advanced HER2 positive cancers and will assess the safety and anticancer activity in breast, gastric and other advanced HER2 positive solid tumors.

Start: March 2018

Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)

Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.

Start: August 2019

A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer

The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.

Start: April 2020

Chemotherapy-induced Peripheral Neuropathy (CIPN) on Motor and Sensory Function

As cancer survival rates have been increased due to technological developments and early detection strategies, there has been been a growing need to assess the effect of long-term complications and adverse effects upon patients' functionality and quality of life. Chemotherapy, which is accepted to be the body of systemic adjuvant therapy is attributed to long-term survival, yet some side effects such as sarcopenia, loss of muscle strength and functional capacity, fatigue, and sensory disturbances due to the neurotoxic effects have been well known. Chemotherapy-induced peripheral neuropathy (CIPN) is a condition that is characterized by main loss of cutaneous sensation especially in the distal part of the extremities. CIPN affects approximately 30-40% of patients with cancer undergoing chemotherapy. Loss of sensation in distal sides of upper and lower extremities may cause not only deterioration of fine hand skills but also loss of balance and thereby one's mobility and independence are detrimentally affected. Thus, this study is aimed to assess CIPN in patients with cancer undergoing chemotherapy in a longitudinal design by assessing the cutaneous function of the sensory nerves and related effect of motor function.

Start: March 2021

Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR

Primary Objective: To determine if dasatinib, an inhibitor of the Src family kinases, can prevent the nuclear translocation of the epidermal growth factor receptor (EGFR) in Stage I-III, nuclear EGFR positive, triple negative breast cancers (TNBC). Secondary Objectives: To examine the safety and tolerability of dasatinib in patients with operable TNBC To explore potential intracellular mechanisms which impact dasatinib effect on cellular localization of EGFR in operable TNBC. To examine the pathologic complete response (pCR) rates to standard neoadjuvant chemotherapy in nEGFR+ TNBC To examine breast cancer recurrence rates and patterns of metastatic recurrent in nEGFR+ TNBC

Start: May 2017

Establishment of Molecular Profiling for Individual Clinical Routine Treatment Decision in Early Breast Cancer

The present project focuses on how to reduce both over- and under-treatment with adjuvant chemotherapy to a large number of breast cancer patients in Norway. A set of primary tumor prognostic factors can be analysed for potential achievement of this. Furthermore, multi-parameter tests, including detailed molecular analysis of the primary tumors might further improve the selection of patients among the lymph node negative. The study seeks to advance the development of personalised treatment of patients with early breast cancer without lymph node metastasis, by the evaluation of multi-parameter analysis as a means of identifying those patients who are likely to benefit from chemotherapy whilst sparing those who are unlikely to do so from an unnecessary and unpleasant treatment.

Start: October 2018

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer

This is a Phase II, randomized, multicenter, 2-arm, open-label clinical trial designed to compare the safety and efficacy of RC48-ADC with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.

Start: April 2018

Telehealth Program to Prevent Cancer and Chemotherapy-related Cognitive Impairment.

The present randomized controlled trial has the main objective to study the effects of a videoconferenced occupational therapy program in preventing cancer and chemotherapy-related cognitive impairment and other health outcomes, as well as in improving quality of live and occupational performance of women undergoing chemotherapy for breast cancer.

Start: October 2020

Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer

This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 or 840 or 420 mg daily oral dose), given in combination with trastuzumab administered through the vein, in patients with HER2-amplified Metastatic Breast Cancer that has gotten worse after prior therapy with ado-trastuzumab emtansine (T-DM1).

Start: November 2017

Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

This pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. Diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise require biopsy for confirmation.

Start: June 2020

ESPB and RIB for Pain Management Following Mastectomy Surgery

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Forero. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs. It has been reported that RIB may provide effective analgesia management for several breast surgeries. The primary aim of the study is to compare postoperative pain scores (VAS), and the secondary aim is to evaluate postoperative opioid consumption, adverse effects related with opioids (allergic reaction, nausea, vomiting).

Start: February 2021

Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer

In this phase I feasibility study, the investigators evaluate the combination of lyso-thermosensitive liposomal doxorubicin (LTLD, ThermoDox) with local hyperthermia and cyclophosphamide (C), for the local treatment of the primary breast tumour in patients with metastatic breast cancer. When heated to 40-43 degrees Celsius (ºC), LTLD releases a very high concentration of doxorubicin locally within seconds. Hyperthermia of the primary tumour will be induced by Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) on a dedicated Sonalleve MR-HIFU breast system. The investigators hypothesize that by substituting doxorubicin (A) in the AC-chemotherapy regimen for the combination of LTLD and MR-HIFU induced hyperthermia, optimal local tumour control can be achieved without compromising systemic toxicity or efficacy. This will be the first study to evaluate LTLD with MR-HIFU hyperthermia in breast cancer patients.

Start: March 2021