A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and Trastuzumab in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breast Cancer and Ribociclib, Trastuzumab, and Tucatinib Versus Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab in Patients With HR-/HER2+ Breast Cancer
This phase Ib/II trial studies the side effects and best dose of ribociclib, tucatinib, and trastuzumab for the treatment of HER2 positive breast cancer that has spread to other parts of the body (metastatic), and then compares the effect of ribociclib, tucatinib, trastuzumab with or without fulvestrant to docetaxel, carboplatin, trastuzumab, and pertuzumab (standard of care) for the treatment of early stage breast cancer before surgery (neoadjuvant therapy). Ribociclib and tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Pertuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Estrogen can cause the growth of breast tumor cells. Fulvestrant blocks the use of estrogen by the tumor cells. Chemotherapy drugs, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib, tucatinib, and trastuzumab with or without fulvestrant before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.
NCT05319873 — Anatomic Stage III Breast Cancer AJCC v8
Status: Recruiting
http://inclinicaltrials.com/anatomic-stage-iii-breast-cancer-ajcc-v8/NCT05319873/
The Evaluation of Intelligence Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life for Newly Diagnosed Non-metastatic Breast Cancer Women: Randomized Controlled Trial.
The aim of this study was to investigate the quality of life (QoL) for women with breast cancer in Taiwan after using the BCSMS App.
NCT04174248 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT04174248/
Multi-Centric Screening of Breast Cancer Patients to Determine Efficiency and to Assess Sensitivity & Accuracy of Pandora CDx MammoAlertTM in Screening of Breast Cancer.
POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast cancer's risk level for a subject by identifying the presence in plasma of known biomarkers. The present study aims to determine the Sensitivity and Specificity of the test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.
NCT03243877 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT03243877/
Next Generation Sequencing to Evaluate Breast Cancer Subtypes and Genomic Predictors of Response to Therapy in the Preoperative Setting for Stage II-III Breast Cancer
This phase II trial studies how well trastuzumab and pertuzumab or bevacizumab with combination chemotherapy works in treating patients with stage II-III breast cancer. Monoclonal antibodies, such as trastuzumab, pertuzumab, and bevacizumab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab and pertuzumab or a commercially marketed formulation of bevacizumab without modification with combination chemotherapy may kill more tumor cells.
NCT01959490 — Stage IIIA Breast Cancer
Status: Completed
http://inclinicaltrials.com/stage-iiia-breast-cancer/NCT01959490/
Treatment Patterns and Clinical Outcomes Among Indian Patients Receiving Palbociclib Combinations for HR+/HER2- Advanced/Metastatic Breast Cancer in Real World Settings
The purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or metastatic breast cancer in India. There are two groups of patients this study will describe. The first group of patients will have received palbociclib in combination with aromatase inhibitor (as prescribed by the Physician) for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The second group of patients will have received palbociclib for the treatment of hormone receptor HR+/HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.
NCT05584644 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT05584644/
Living Better With Advanced Breast Cancer (LIBERATE) Phase II: Evaluating the Feasibility of a Supportive, Self-management Website in Women Living With Secondary Breast Cancer.
The LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Overall, this intervention aims to improve quality of life among this growing group of patients through targeted, tailored and accessible information and support. This randomised waiting list control trial aims to evaluate the feasibility of the clinically integrated LIBERATE intervention. Results of participants' online symptom monitoring questionnaires are integrated with their electronic patient record, enabling clinician review and follow up alongside participants' own self-management activities.
NCT04173897 — Metastatic Breast Cancer
Status: Completed
http://inclinicaltrials.com/metastatic-breast-cancer/NCT04173897/
Experience of Arab American Women With Breast Cancer: In-depth Interviews A Qualitative Study to Explore the Influence of the Arab Culture on Coping With Breast Cancer
The investigators are conducting a study entitled 'Experience of Arab American Women with Breast Cancer: In-depth Interviews' through which they hope to learn more about Arab women's experience with breast cancer.
NCT02710058 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT02710058/
The Impact of Obesity and Obesity Treatments on Breast Cancer: A Phase I Trial of Exemestane With Metformin and Rosiglitazone for Postmenopausal Obese Women With ER+ Metastatic Breast Cancer
The goal of this clinical research study is to find the highest tolerable dose of Avandamet that can be given in combination with exemestane to patients who are obese and postmenopausal with hormone-receptive-positive breast cancer that has spread to other parts of the body.
NCT00933309 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00933309/
ER/HER2/Ki67 Breast Cancer Subtypes as Predictive Factors for Response to Adjuvant Dose-dense Therapy, and Basal Subtypes of Double-negative Breast Cancer as Prognostic Factors in Intergroup Trial C9741
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors plan the best treatment. PURPOSE: This research study is looking at tissue samples from women who underwent chemotherapy for lymph node-positive stage II or stage IIIA breast cancer.
NCT00897026 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00897026/
Enhancing Efficacy of Chemotherapy in Triple Negative/Basal-Like Breast Cancer by Targeting Macrophages: A Multicenter Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer
The purpose of the Phase 1b portion of the study is to determine the best dose of PLX3397 when given in combination with standard dose eribulin (Halaven™). The purpose of the Phase 2 portion of the study is to find out what effects, good and/or bad, these drugs have on patients and their metastatic breast cancer.
NCT01596751 — Metastatic Breast Cancer
Status: Completed
http://inclinicaltrials.com/metastatic-breast-cancer/NCT01596751/