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Breast Cancer clinical trials

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NCT ID: NCT04926766 Recruiting - Breast Cancer Clinical Trials

Super Hypofractionated Irradiation For Whole Breast Treatment

SHIFT
Start date: December 23, 2020
Phase: N/A
Study type: Interventional

The purpose of this trial is to investigate the safety and efficacy of super hypofractionated whole breast irradiation (SHF-WBI) in breast cancer patients treated with breast conserving surgery. Eligible breast cancer patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, distant metastasis, death, contralateral breast cancer and quality of life.

NCT ID: NCT04925856 Recruiting - Breast Cancer Clinical Trials

Immunomonitoring of Breast Cancer Patients During Systemic Treatment

IMMUNE CAPTURE
Start date: May 26, 2020
Phase: N/A
Study type: Interventional

This study aims to constitute a most complete biological collection for patients treated for localized or metastatic breast cancer (in different cohorts depending on the type of systemic treatment received), in order to describe the basal immune response of patients treated for a breast cancer according to the stage of the disease, but above all to study how the different systemic treatments used in the management of breast cancer modulate this immune response.

NCT ID: NCT04925817 Not yet recruiting - Breast Carcinoma Clinical Trials

3D Ultrasound Microvessel Imaging for Breast Masses

Start date: July 1, 2021
Phase: Early Phase 1
Study type: Interventional

This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.

NCT ID: NCT04924010 Recruiting - Breast Cancer Clinical Trials

Effect of Perioperative CBT on Chronic Persistent Postsurgical Pain Among Breast Cancer Patients

Start date: May 31, 2021
Phase: N/A
Study type: Interventional

Chronic persistent post-surgical pain (CPSP) is defined as pain at or near the site of surgery persisting for 3 months or more after the date of surgery. The incidence CPSP in Europe is up to 50% at 3 months and 12% at 12 months, but the incidence varies depending on surgical procedure [Fletcher D et al]. In Breast surgery, one of the most commonly performed surgical procedures for cancer [Kehlet H et al], CPSP has been observed in 20-30% of patients at 6 months after surgery, making this group among the highest risk of developing CPSP [Spivey TL et al & Weiser TG et al]. Clinical developments that could mitigate the development of CPSP after breast cancer surgery would potentially yield multiple benefits in terms of reducing future healthcare utilization, associated costs [Spivey Tl et al], and improving their physical and mental health. Several predictive factors for CPSP have been identified, the most important being chronic pre-operative pain, high intensity of acute postoperative pain, and several psychological factors [Vranceanu A-M et al]. Of these psychological factors, pain catastrophizing has emerged as one of the strongest predictors of pain severity and disability among individuals with a range of pain presentations and CPSP [Leung L & Wade Jb & Wildeman TH]. Catastrophizing is described as a maladaptive psychological coping strategy involving an exaggerated reaction to anticipated or actual pain. It can involve mental rumination, magnification of the perceived danger or threat associated with pain, and feelings of helplessness in relation to what can be done [Leung L et al]. A recent systematic review on psychological interventions undergoing major elective abdominal surgery concluded catastrophization can have a direct influence on the neuropathophysiological mechanisms underlying pain experiences and can improve pain and psychological outcomes, after surgery [Villa G et al]. In recent years, there has been a growing number of studies investigating the potential impact of perioperative psychological interventions in a variety of patient groups. A recent systematic review and meta-analysis of observational studies concluded that psychological predictors may have a significant association with chronic postsurgical pain, including catastrophization, although this conclusion is limited by the heterogeneity of study designs and methods used [Giusti et al]. To our knowledge, no randomized controlled trial has been done to date, investigating the influence of perioperative psychological interventions on CPSP in patients undergoing breast cancer surgery.

NCT ID: NCT04922008 Not yet recruiting - Breast Cancer Clinical Trials

Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS-C/D)

Start date: July 1, 2021
Phase: Phase 2
Study type: Interventional

This is an open label, phase II study evaluating the efficacy and safety of trastuzumab combined with oral chemotherapy (capecitabine or vinorelbine) in patients with HER-2 positive stage I breast cancer.

NCT ID: NCT04921137 Not yet recruiting - Breast Cancer Clinical Trials

Evaluating Harms and Benefits of Endocrine Therapy in Patients ≥70 Years of Age With Lower Risk Breast Cancer

Start date: September 2021
Phase: Phase 4
Study type: Interventional

The current standard of care for stage 1 hormone receptor-positive (HR+) breast cancer consists of breast-conserving surgery followed by adjuvant radiotherapy (RT) and endocrine therapy (ET) for at least 5 years. The benefit of adjuvant ET for older patients is mitigated because of their increase risk of death from other causes and shorter time horizon to live. Clinical and pathological factors such as low-intermediate grade, tumor size ≤2 cm, and older age have been used in a few studies to identify patients with a lower risk of recurrence that might benefit from adjuvant therapy de-escalation, i.e. omission of RT or ET. Since there is no dedicated randomized clinical trial (RCT) conducted to evaluate the omission of ET, there is clinical equipoise as to whether we can omit adjuvant ET in older patients with lower-risk early-stage breast cancer. Therefore, we propose a randomised, multicentre trial evaluating harms and benefits of endocrine therapy in patients ≥70 years of age with lower risk breast cancer.

NCT ID: NCT04920656 Recruiting - Breast Cancer Clinical Trials

Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer

Start date: April 1, 2021
Phase:
Study type: Observational

The study aims to examinethe pattern and frequency of pathogenic variants among all newly diagnosed breast cancer patients in a genetically distinct population. Additionally, the uptake rate of "cascade family screening" , frequency of pathogenic variants and barriers against testing will be studied.

NCT ID: NCT04918589 Not yet recruiting - Breast Cancer Clinical Trials

Tranexamic Acid for Alloplastic Breast Reconstruction

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

Hematoma is a common complication of alloplastic breast reconstruction. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events. In this randomized control trial (RCT) assessing TXA use in alloplastic breast reconstruction, one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in alloplastic breast reconstruction reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.

NCT ID: NCT04917900 Recruiting - Breast Cancer Clinical Trials

Single-arm, Multi-center Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin-bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of Her2-positive Early or Locally Advanced Breast Cancer

Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

This study aimed to evaluate the pyrrole imatinib in combination with albumin paclitaxel and trastuzumab to neoadjuvant therapy efficacy and safety of Her2-positive early or locally advanced breast cancer

NCT ID: NCT04917640 Recruiting - Breast Cancer Clinical Trials

Registry for Accelerated Partial Breast Irradiation With (SBRT) or (IMRT)

Start date: June 2021
Phase:
Study type: Observational

This is a registry study that will be used to evaluate external beam radiation therapy methods for the accelerated treatment of breast cancer. Patients are being asked to take part in this registry because they have breast cancer and desire treatment with accelerated partial breast irradiation to be delivered by external beam methods.