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Breast Neoplasms clinical trials

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NCT ID: NCT04258813 Recruiting - Hypertension Clinical Trials

Onco-primary Care Networking to Support TEAM-based Care

ONE TEAM
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with >1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be ~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.

NCT ID: NCT04258735 Recruiting - Clinical trials for Metastatic Breast Cancer

Genetic Characteristics of Metastatic Breast Cancer Patients

Start date: July 17, 2019
Phase: N/A
Study type: Interventional

Genomic analysis for metastatic breast cancer(MBC) patients - Participant (Inclusion criteria) 1. Patients who diagnosed metastatic/stage IV breast cancer 2. Patients who were not received treatment for metastatic breast cancer on palliative setting - Process (1) Tissue/ Blood sample - At diagnosis, MBC tissue / blood sample (20cc) will be obtained. - At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional) (2) WES, RNASeq, ctDNA, Exosome - We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.

NCT ID: NCT04258163 Completed - Clinical trials for Metastatic Breast Cancer

Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy

Start date: January 1, 2019
Phase:
Study type: Observational

To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).

NCT ID: NCT04258085 Completed - Breast Cancer Clinical Trials

Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System

Start date: July 1, 2020
Phase:
Study type: Observational

This observational study evaluates scale-up of a breast cancer early detection program in Rwanda that was initially piloted in a single district. Specifically investigators will examine patient volume, service delivery, loss-to-follow-up rates, and cancer detection rates noted following implementation of scale-up to 3 additional districts. For scaleup, breast cancer screening with CBE was added to a cervical cancer screening initiative, in a combined Women's Cancer Early Detection Program (WCEDP).

NCT ID: NCT04257045 Active, not recruiting - Breast Carcinoma Clinical Trials

Factors Influencing Cascade Testing Among Women With Hereditary Gynecological Cancers and Their Relatives

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

This trial collects information about factors that affect communication of genetic test results, decision-making, and access to genetic testing in women with hereditary gynecological cancers. Studying individuals who are positive for a genetic mutation and immediate biological family members (including a parent, full-sibling, or child) may help identify cancer genes and other persons at risk.

NCT ID: NCT04256941 Completed - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

Start date: May 31, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well letrozole, anastrozole, or fulvestrant work when given together with ribociclib, palbociclib, and/or abemaciclib in treating patients with hormone receptor (HR) positive breast cancer that has spread to other places in the body (metastatic) and has an ERS1 activating mutation. Letrozole, anastrozole, ribociclib, palbociclib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known if giving letrozole, anastrozole, or fulvestrant with ribociclib, palbociclib, and/or abemaciclib will work better in treating patients with breast cancer.

NCT ID: NCT04256512 Completed - Breast Carcinoma Clinical Trials

Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients

Start date: March 10, 2020
Phase: N/A
Study type: Interventional

This clinical trial investigates the effect and tolerability of cryotherapy and to evaluate whether they can prevent or improve taxane-induced sensory peripheral neuropathy in breast cancer patients. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Patients receiving cryotherapy during infusion of taxane therapy may have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.

NCT ID: NCT04255056 Not yet recruiting - Breast Cancer Clinical Trials

Pyrotinib in Breast Cancer Patients With Poor Response to the Neoadjuvant Treatment of Trastuzumab and Pertuzumab

PRETTY
Start date: February 1, 2020
Phase: Phase 2
Study type: Interventional

Pathological complete remission (pCR) after neoadjuvant therapy in HER2-positive early breast cancer patients is closely related to disease-free survival (DFS) and overall survival (OS), which makes pCR an important evaluation indicator of recurrence risk. Trastuzumab combined with pertuzumab is a new standard targeted treatment regimen for HER2-positive early breast cancer. However, there are still quite a few patients who do not reach PCR. For these patients, current guidelines recommend the use of TDM-1 for intensive treatment after surgery, although a significant number of patients still have recurrence or metastasis. Besides, TDM-1 is unavailable in China. Pyrotinib has been approved for HER2-positive breast cancer patients who have previously failed after the treatment of trastuzumab. The investigators intend to conduct this phase II clinical study. Patients with poor response to the standard neoadjuvant treatment regimen of trastuzumab combined with pertuzumab are enrolled. These patients receive pyrotinib to observe that whether pCR has been improved. The investigators aim to explore the effect of pyrotinib in patients with poor response to standard dual-target neoadjuvant therapy, and further explore the improvement of neoadjuvant treatment strategy in HER2 positive early stage breast cancer patients.

NCT ID: NCT04254263 Recruiting - Clinical trials for Locally Advanced Breast Cancer

Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

ATP
Start date: December 16, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.

NCT ID: NCT04253561 Recruiting - Clinical trials for Metastatic Breast Cancer

Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients

IPATHER
Start date: February 25, 2020
Phase: Phase 1
Study type: Interventional

This is an open label, single arm, multicenter, phase Ib study to evaluate the safety and clinical activity of the combination of ipatasertib, trastuzumab and pertuzumab in patients with unresectable locally advanced or metastatic HER2-positive breast cancer with tumors harboring PIK3CA mutations, candidates to receive maintenance HP after first line treatment for metastatic disease with a taxane plus HP