View clinical trials related to Early-Stage Breast Cancer.
Filter by:Research background: Neratinib is an irreversible pan HER tyrosine kinase inhibitor, which belongs to one of tyrosine kinase inhibitors (TKI). In the non pCR HER2 positive breast cancer patients after neoadjuvant therapy, there is no study on macromolecular anti HER2 drugs combined with TKI drugs to treat HER2 positive breast cancer patients after neoadjuvant therapy. In addition, there is no prospective randomized controlled study results of trastuzumab combined with patuzumab versus trastuzumab combined with TKI drugs for HER2 positive breast cancer patients with RCBI-II after new adjuvant treatment. To sum up, this study is intended to design and evaluate the efficacy and safety of trastuzumab combined with nelatinib in the treatment of hormone receptor positive HER2 positive breast cancer RCBI-II patients after the new adjuvant treatment of trastuzumab combined with patouzumab. Objective: This study was designed to evaluate the efficacy and safety of trestuzumab combined with nelatinib in the adjuvant treatment of breast cancer patients with hormone receptor positive HER2 positive RCB I-II after the neoadjuvant treatment of trestuzumab combined with partuzumab. Trial design: Single center, randomized controlled phase III clinical study. Study content: Study content: The qualified subjects will be randomly (1:1) treated with the following scheme: Treatment plan: Experimental group: Trastuzumab combined with nelatinib Control group: Trastuzumab combined with Parstuzumab Nilatinib: Take 240 mg (6 tablets) orally once a day, which can be taken with food every 21 days as a cycle. After surgery, it starts to be used together with trastuzumab, and stops the next cycle when trastuzumab treatment is completed. Trastuzumab: loading dose 8mg/kg, maintenance dose 6mg/kg, intravenous infusion, once every three weeks, with a total of 18 cycles during the new adjuvant treatment. Patuzumab: loading dose 840mg/kg, maintenance dose 420mg, intravenous infusion, once every three weeks, with a total of 18 cycles during the new adjuvant treatment. Observation index: main index: Invasive disease free survival (IDFS) refers to the time from randomization to the first occurrence of local or distant disease recurrence or death. Secondary indicators: 1. Disease free survival (DFS): refers to the time from randomization to disease recurrence or death due to disease progression. 2. Overall survival (OS): the time from randomization to death from any cause. 3. Distant disease free survival (DDFS): the time when no metastatic lesion was found in other places except the primary lesion after treatment. 4. Incidence and severity of adverse events
The goal of this randomized, pragmatic clinical trial is to evaluate the omission of granulocyte colony-stimulating factors (G-CSF) in breast cancer patients receiving paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T) chemotherapy. Participants will be randomized to either take G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy or to omit G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy.
The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.
This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.
This research is being done to determine whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy (CIPN), a side effect of some kinds of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness mostly in the hands or feet. This research will also help determine whether acupuncture can improve quality of life in patients receiving taxane-based chemotherapy for the treatment of breast cancer. The names of the study activities involved in this study are/is: - Acupuncture treatments for participants in the Acupuncture Group - Nature videos with a relaxation exercise for participants in the Relaxation/ Exercise Group The Comprehensive and Integrative Medicine Institute (CIMI) of South Korea is supporting this research study by providing funding.
Cardiotoxicity is one of the most significant adverse effects in breast cancer patients treated with anthracyclines (a type of chemotherapy), so we propose to determine whether acute training (i.e., 24h before each chemotherapy session) could reduce the levels of a cardiac biomarker which measures muscle damage (NT-proBNP). Given the fact NT-proBNP attenuation has been observed with one session performed 24h before the first treatment, we propose to verify these findings in each cycle of doxorubicin analyzing how each type of exercise (aerobic, strength or combined aerobic + strength) may impact on anthracycline-induced cardiotoxicity, since this observation may be relevant considering the feasibility and low cost this implementation would represent in clinical practice.
This research study is being done to implement a screening program for prediabetes, diabetes, dyslipidemia and/or hyperlipidemia, and higher risk of cardiovascular disease in breast cancer survivors. This program will also help to direct individuals with risk factors to community and institutional resources for management.
The main purpose of this study is to evaluate the quality of life of premenopausal participants with Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor-2 (HER2) negative breast cancer who are receiving, in addition to triptorelin, an endocrine cancer treatment. The study will also get more information about: - the effectiveness and safety of triptorelin; - the relationship that could exist between the characteristics of the disease and the treatment chosen by the Investigator.
This study is a prospective, multi-center, open-label cohort study, with 3 years disease free survival(DFS) as the primary endpoint. We optimize post-operation adjuvant therapy for early stage breast cancer based on the MRD strategy: patients with clinical high risk or post-operation 1st MRD tested positive will receive intensive adjuvant therapy, while patients with low clinical risk and post-operation 1st MRD tested negative will receive standard adjuvant therapy, and the treatment regimens will be adjusted every 3 months according to the change of MRD status. About 100 TNBC patients, 100 HER2+ patients, and 100 ER+ patients are planned to be enrolled.
In early breast cancer (eBC), pathological complete response (pCR) after neoadjuvant therapy acts as surrogate marker for metastasis and overall survival. Therapy intensification by adding an adjuvant therapy line (post-neoadjuvant treatment) substantially lowers the risk of relapse in high-risk breast cancer patients with residual disease after neoadjuvant treatment (non-pCR). While this approach was exemplified in two phase III trials without biomarker-stratification (CREATE-X, KATHERINE), even higher efficiency might be achieved by individualized genomic-guided post-neoadjuvant therapies. Within the seven-arm umbrella phase-II clinical trial COGNITION-GUIDE, we aim to deliver molecularly-tailored cancer care by implementing an additional response- and genomics-guided post-neoadjuvant therapy after finishing the guideline-compliant post-neoadjuvant treatment in high-risk breast cancer patients with residual cancer burden after neoadjuvant therapy to reduce the substantial risk of local and distant relapse. The trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials. Allocation to the therapy-arms is conducted by in depth molecular characterization of tumors within the COGNITION registry program. The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm. The primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.