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Breast Neoplasms clinical trials

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NCT ID: NCT04877860 Recruiting - Breast Cancer Clinical Trials

Pain Treatment in a Breast Cancer Population. PaiNEd Study.

PaiNEd
Start date: April 4, 2022
Phase: N/A
Study type: Interventional

The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information. This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to three study groups.

NCT ID: NCT04877821 Recruiting - Clinical trials for Triple Negative Breast Cancer

The Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in TNBC

NeoSACT
Start date: September 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Sintilimab plus anlotinib combined with chemotherapy as neoadjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Sintilimab + anlotinib + chemotherapy) based on schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 4-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary outcome measure is pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0.

NCT ID: NCT04876560 Completed - Breast Cancer Clinical Trials

Implementation of a CDSS in Oncology Patients During COVID-19

CDSS
Start date: March 11, 2020
Phase: N/A
Study type: Interventional

The present randomised controlled trial aimed to investigate the effectiveness of a clinical decision support system (CDSS) in assisting clinicians to apply nutritional care to breast cancer (BC) patients during the COVID-19 pandemic in Greece. Adult BC women (stages I-IIIA) who underwent mastectomy followed by hormone therapy were randomly assigned either to the Control group, receiving general nutritional advice, or the Intervention (or CDSS) group, in whom a personalised nutritional programme based on the Mediterranean diet together with physical activity guidelines were provided, all produced by CDSS. Medical and dietary history, anthropometrics, biochemical indices and quality of life characteristics were assessed both at baseline and at the end of the study (3 months).

NCT ID: NCT04876378 Terminated - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand

Start date: May 18, 2020
Phase:
Study type: Observational

This study investigates the impact of breast cancer treatment on joint health, cartilage, composition, and bone structure in the knee and hand in patients with hormone-receptor positive stage I-III breast cancer and healthy patients. The investigators will use Magnetic Resonance Imaging (MRI) to assess the quality of hand and knee joints. This study may help doctors learn more about hand and knee joint pain that occurs during aromatase inhibitor treatment.

NCT ID: NCT04875559 Completed - Postoperative Pain Clinical Trials

Multimodal Pain Treatment for Breast Cancer Surgery - a Prospective Cohort Study

Start date: April 19, 2021
Phase:
Study type: Observational [Patient Registry]

Breast cancer is one of the most common types of cancer among women worldwide. (1) Breast-conserving surgery or mastectomy is indicated for the majority of patients with this type of cancer. (2) Postoperative pain is frequent in this population, with almost 50 % experiencing acute pain and 25-60 % subsequently live with chronic pain. (3-5) Today no golden standard for postoperative pain management regarding breast cancer surgeries exists, and there is definitely room for improvement. Especially considering the large population of women with breast cancer and consequences of acute and chronic pain, such as prolonged recovery and affected quality of life. (6,7) With the present study, we aim to optimise postoperative pain treatment and investigate the effect of a standardised multimodal postoperative analgesic regimen based on previous recommendations. (4,8,9)

NCT ID: NCT04875351 Active, not recruiting - Breast Cancer Clinical Trials

Breast Cancer Index (BCI) Registry

Start date: April 14, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of the Breast Cancer Index (BCI) Registry study is to conduct a large scale, population-based prospective registry to evaluate long-term clinical outcome, clinical impact, medication adherence and quality of life in hormone receptor positive (HR+) early-stage breast cancer patients receiving BCI testing as part of routine clinical care to inform extended endocrine therapy.

NCT ID: NCT04874935 Completed - Breast Cancer Clinical Trials

The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer

Start date: June 10, 2021
Phase: Phase 3
Study type: Interventional

Investigation of the possible efficacy and safety of lansoprazole co-administration with neoadjuvant chemotherapy in tumor response in women with breast cancer who will be planned for surgery.

NCT ID: NCT04874064 Recruiting - Breast Cancer Clinical Trials

TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence

TRICIA
Start date: December 5, 2019
Phase:
Study type: Observational

Triple negative breast cancer (TNBC) is the most aggressive of breast cancers and it is usually treated with chemotherapy even before surgery. In many cases, the chemotherapy completely "melts" the tumor and these patients do well. When the tumor is not eliminated by the chemotherapy, the patient receive more chemotherapy after surgery to decrease the chances of it coming back. Yet many of these patients don't need that extra chemotherapy and will do well in any case. One of the most exciting recent developments in cancer is the use of "liquid biopsies". It turns out that the tumor's DNA, RNA and proteins can be detected in small vesicles found in the patient's blood. Thanks to advances in Artificial Intelligence, there is now informatics tools to integrate many types of molecular information. Our industrial partner, MIMs, will apply novel informatics tools to generate a test using all the molecular information obtained from blood vesicles and tissue that will be able to find out early if tumor has spread outside of the breast, and how much tumor is left after surgery. The goal is hope to develop a multi-dimensional test for TNBC patients that can be used to decide how much treatment they need and if treatment given after surgery is working.

NCT ID: NCT04874038 Recruiting - Breast Cancer Clinical Trials

Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)

Start date: September 22, 2021
Phase: Phase 3
Study type: Interventional

Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.

NCT ID: NCT04874025 Completed - Breast Cancer Clinical Trials

Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer

PALBOSPAIN
Start date: July 31, 2021
Phase:
Study type: Observational

Hormone therapy is the primary treatment option for patients with HR+ HER2- breast cancer. Despite its activity, hormone therapy is associated with initial, or more frequently acquired, resistance after exposure to one or more treatment lines. The combination of palbociclib with hormone therapy significantly increases progression free survival (PFS) compared with hormone therapy in first and second treatment line of HR+ HER2- advanced breast cancer. These results lead to palbociclib approval by the Food and Drug Administration (FDA) in February 2015, and European Medicines Agency (EMA) approval in November 2016 for first-line treatment of patients with metastatic HR+/HER2-breast cancer in combination with an aromatase inhibitor, and for patients who had previously received hormone therapy in combination with fulvestrant. In Spain, palbociclib was launched last November 1st, 2017. During this period, approximately 3500 patients have received treatment with Palbociclib, and approximately a half of them in first-line treatment in combination with hormone therapy. The collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest.