Adjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive and Lymph Node Negative Invasive Breast Cancer
This is an open label, phase III study evaluating the efficacy and safety of Pyrotinib in Combination With Trastuzumab and paclitaxel in patients HER2 Positive and lymph node negative invasive Breast Cancer
NCT05841381 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT05841381/
Metformin Effect as a Chemotherapeutic Adjuvant on Level of IGF in Non-diabetic Breast Cancer Patients
The purpose of this study is to examine the impact of metformin as an adjuvant to chemotherapy on IGF levels in both progressing and non progressing cases of metastatic breast cancer in female patients.
NCT05840068 — Breast Cancer Female
Status: Completed
http://inclinicaltrials.com/breast-cancer-female/NCT05840068/
Pyrotinib Plus Trastuzumab and Chemotherapy in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study
To evaluate the patterns and treatment outcomes of pyrotinib plus trastuzumab and chemotherapy in the real world.
NCT05839288 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT05839288/
Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study
All participants will read a decision aid (DA) communicating evidence about mammography screening benefits and harms. Participants' evaluations of that evidence will be assessed, along with their screening intentions and receipt of screening. Participants will be sent 3 surveys via email and a final brief survey conducted by email or phone. The four surveys will be collected 1) upon enrollment and prior to the primary care appointment; 2) following the primary care appointment; 3) 3 months after enrollment; 4) 1 year after enrollment. The final 2 surveys will offer an increased incentive to increase retention rates.
NCT05838417 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05838417/
Multicenter Study to Evaluate the Impact of a Systematized Communication Model to Increase the Knowledge of Breast Cancer Patients About Their Disease
Both in Mexico and in the world, breast cancer is the most common malignancy in women. It is estimated that in 2020, 28.2% of the new cancer cases reported in our country correspond to breast cancer, which translates to 30,000 new cases. In addition, it is relevant to mention that approximately 12% of Mexican patients are diagnosed with stage IV breast cancer and it is estimated that 20-30% of women with early stage cancer will have a distant recurrence of the disease. Thus, about 40% of patients will find themselves in a metastatic stage at some point in their breast cancer journey. Various studies, including Mexico, report that only half of patients with metastatic breast cancer are aware that their disease is not curable, 31% say they are not sure, and 17% think it is curable. Likewise, 58% considered that they did not have enough knowledge to actively participate in conversations about their therapeutic options, which means that 40% reported difficulty talking about treatments with their doctors. This has shown that there are suboptimal levels of knowledge information on curability, treatment objectives and prognosis of their condition in patients with metastatic breast cancer. This lack of understanding is alarming given that a general understanding of the disease is crucial for informed decision making and adherence to cancer treatment. Due to these alarming results, we seek to recruit women ≥18 years of age who are candidates to start first- or second-line treatment for de novo or recurrent metastatic breast cancer from various hospital centers in the country with public and private coverage, including Hospital Zambrano Hellion TecSalud as coordinating center in Nuevo León. The objective will be to evaluate whether a systematized communication model for patients with metastatic breast cancer allows increasing knowledge about the non-curative nature of treatment, compared to usual care.
NCT05837533 — Communication
Status: Recruiting
http://inclinicaltrials.com/communication/NCT05837533/
Randomized Study With Wait-list Control to Evaluate the Impact of a Stress Reduction Intervention Based on Mindfulness Offered Virtually to Reduce Anxiety Levels in Breast Cancer Survivors
The diagnosis and treatment of breast cancer (BC) can drastically affect the quality of life of patients with this disease by causing symptoms of vasomotor disorders, insomnia, depression and anxiety. Mindfulness-Based Stress Reduction (MBSR) is a program dedicated to fostering complete awareness in the present in order to accept the moment, thereby reducing stress. Previous studies have shown that MBSR benefits patients with chronic conditions such as mood disorders and chronic pain, as well as patients with BC. However, its usefulness in Mexican patients has not been previously studied.
NCT05837169 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT05837169/
Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria
The study will be a randomized controlled trial. The aim of the study is to determine the Breast Cancer (BC) risk and to evaluate the effect of BC risk counseling on lifestyle changes and adherence to risk-reduction practices among first-degree female relatives of BC patients in South-West Nigeria. This study's research questions are: - What are the Nigeria Breast Cancer Study (NBCS) and Gail models estimates of the BC risk of first-degree female relatives of BC patients in South-West, Nigeria? - What are the effects of BC risk assessment and counseling on adherence to breast screening recommendations among first-degree female relatives of BC patients in South-West, Nigeria? - What are the effects of BC risk assessment and counseling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of BC patients in South-West, Nigeria? - What is the knowledge, attitudes, and perception of first-degree female relatives of BC patients in South-West Nigeria towards genetic testing and BC etiology? - What factors predict breast screening among first-degree female relatives of BC patients in South-West Nigeria? - What factors predict the time to first BC screening (post-intervention) among first-degree female relatives of BC patients in South-West Nigeria? Participants will be randomized into the control arm (standard care) and intervention arms of the study. The intervention arm of the study will have a BC risk assessment followed by individualized BC risk counseling. In addition, the intervention arm will receive BC awareness and MammaCare® BSE training. The control arm will receive only standard care comprising BC awareness and MammaCare® BSE training. Both study arms will receive BC screening recommendations and lifestyle modification recommendations. We hope that the BC risk counseling will improve BC screening practices and modification of risk behaviors and this hypothesis will be tested.
NCT05834933 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT05834933/
Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer
ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached. However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.
NCT05834764 — HER2-positive Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/her2-positive-breast-cancer/NCT05834764/
Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.
NCT05831878 — Advanced Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/advanced-breast-cancer/NCT05831878/
Extracellular Vesicles as a Diagnostic and Prognostic Biomarker of Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients.
Extracellular vesicles (EVs) are lipid bilayer-delimited particles, naturally released from the cells and mediators of intercellular cross-talk. In breast cancer (BC), EVs seem to be involved in the tumor microenvironment's shaping, in cancer cells invasion and in the set-up of metastasis. Clinical studies have provided initial evidence that EVs may have a prognostic and predictive value in breast cancer. Considering their presence in body fluids and their minimally invasive assessment through blood sampling, EVs could be liquid biopsy-derived biomarkers. Their quantification could be a complex challenge, requiring complicated and time-consuming pre-analytical procedures of EVs isolation. A new method for the detection of tumor-derived-EVs associated proteins is based on the use of Single Molecule Array (SiMoA), a digital ELISA technology able to detect and quantify extremely low concentrations of target proteins or particles. The aim of this study is to evaluate how this new technology can allow the quantification EVs plasma levels in patients affected by BC, providing useful diagnostic and prognostic information about the efficacy of the neoadjuvant treatment.
NCT05831397 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05831397/