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Breast Neoplasms clinical trials

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NCT ID: NCT04974567 Active, not recruiting - Breast Cancer Clinical Trials

Tear Based Sample Collection Breast Cancer Detection

Start date: April 28, 2021
Phase:
Study type: Observational

This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.

NCT ID: NCT04973930 Recruiting - Breast Cancer Clinical Trials

Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metastatic Breast Cancer

IPT
Start date: March 1, 2022
Phase: Phase 3
Study type: Interventional

Cancer and depression commonly occur together, and each worsens the other. We conducted a large psychotherapy study treating depression in breast cancer patients, showing that psychotherapy lowers symptoms. Surprisingly, no studies have compared depression-focused psychotherapy to antidepressant medication for patients with breast cancer and depression. We applied to the National Cancer Institute for a large, cross-national grant. Reviewers asked us to first demonstrate that patients would accept either psychotherapy or medication as treatment. Thanks to funding from the Columbia Herbert Irving Cancer Center, we will test this study approach. We will randomly assign 20 patients with both non-metastatic breast cancer and major depression to 12 weeks of tele-therapy (by Zoom) with either interpersonal psychotherapy or a serotonin reuptake inhibitor. We expect patients in both treatments to report improvement in depression symptoms. We will also measure C-reactive protein, a blood test of inflammation elevated in both cancer and depression, which may predict medication response.

NCT ID: NCT04973319 Not yet recruiting - Breast Cancer Clinical Trials

Trastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy

Start date: August 1, 2021
Phase: Phase 3
Study type: Interventional

Patients with HER-2 positive breast cancer who have poor outcomes after endocrinotherapy and standard chemotherapy can be significantly improved by the use of anti-HER-2 monoclonal antibody trastuzumab. In the current clinical practice of neoadjuvant therapy, trastuzumab combined with chemotherapy can significantly increase the pCR and improve the outcomes in patients. However, there seems to be no available treatment for patients who have no pCR and still have residual tumors except for sequential trastuzumab treatment for 1 year. Compared with trastuzumab, a HER-2 macromolecule inhibitor, pyrotinib has a different site of action and an increased EGFR target. Compared with lapatinib, a small molecule inhibitor of EGFR and HER-2, pyrotinib is an irreversible inhibitor, with the ability to achieve a better curative effect at a lower human plasma exposure level. This trial is designed to evaluate the effectiveness and safety of trastuzumab combined with pertuzumab followed by sequential pyrotinib treatment in non-pCR patients after neoadjuvant therapy.

NCT ID: NCT04972448 Not yet recruiting - Breast Cancer Clinical Trials

RecurIndex Predicts Risk of Recurrence in Early-stage Luminal Breast Cancer

Start date: July 2021
Phase:
Study type: Observational

This study will conduct a multicenter, open, prospective clinical trial to observe the RecurIndex to assist in predicting the risk of recurrence in patients with early-stage Luminal-type breast cancer. The aim of this study is to validate the predictive effect of the RecurIndex on the risk of recurrence in women with early-stage Luminal-type breast cancer in China.

NCT ID: NCT04971304 Completed - Clinical trials for Lymphoma, Non-Hodgkin

Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars

Start date: March 1, 2015
Phase:
Study type: Observational

This comparative effectiveness and descriptive retrospective cohort study will evaluate safety and effectiveness outcomes among commercially insured adults who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy.

NCT ID: NCT04970264 Recruiting - Breast Cancer Clinical Trials

A Multicenter, Open and Observational Real World Study on the Prognosis and Treatment in Young Women With Breast Cancer

Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. The secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients. We expect to enroll 2000 young breast cancer patients (≤35 years old). All patients were detected by targeted next generation sequencing (NGS)(600+ gene panel). Clinical diagnosis, treatment and prognosis information were collected. The Stratification factors mainly include stage, molecular type and treatment method.

NCT ID: NCT04968964 Recruiting - Breast Cancer Clinical Trials

Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing

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

Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems. The DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and/or timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.

NCT ID: NCT04967976 Recruiting - Breast Cancer Clinical Trials

Breast Mesh Used in Two-staged Breast Reconstruction

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.

NCT ID: NCT04967248 Recruiting - Clinical trials for Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation

A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting

Start date: June 21, 2023
Phase:
Study type: Observational

This is a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who are treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.

NCT ID: NCT04967209 Completed - Breast Cancer Clinical Trials

Investigation of a Digital Healthy Habits Program for Individuals With Breast Cancer

Start date: July 5, 2021
Phase:
Study type: Observational

This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app (features they liked and didn't like), the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.