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Breast Cancer clinical trials

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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: NCT04946227 Not yet recruiting - Breast Cancer Clinical Trials

Pembrolizumab and Paclitaxel in Hormone Receptor-positive, hyperMUTATted Metastatic Breast Cancer Identified by Whole exOme sequeNcing ('MUTATION2')

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

Abbreviated Title :Pembrolizumab with paclitaxel in hypermutated breast cancer Trial Phase: Phase II Clinical Indication: Hormone receptor-positive metastatic breast cancer Trial Type: Interventional Type of control: None Route of administration: Intravenous Trial Blinding: None Treatment Groups : Pembrolizumab plus paclitaxel Number of trial participants: Approximately 200 patients will be prescreened with whole exome sequencing. Then 52 patients will be enrolled in the treatment phase. Estimated enrollment period :12 months Estimated duration of trial :The sponsor estimates that the trial will require approximately 24 months from the time the first subject signs the informed consent until the last subject's last visit. Duration of Participation :24 months Estimated average length of treatment per patient :8 months

NCT ID: NCT04929548 Not yet recruiting - Breast Cancer Clinical Trials

Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP

Start date: January 5, 2022
Phase: Phase 4
Study type: Interventional

This study is a single-arm, single-center exploratory clinical study. Twenty patients with early-stage HER2-positive breast cancer are planned to be included, and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab + pertuzumab.

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: NCT04918589 Not yet recruiting - Breast Cancer Clinical Trials

Tranexamic Acid for Alloplastic Breast Reconstruction

Start date: August 2022
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: NCT04895397 Not yet recruiting - Breast Cancer Clinical Trials

Modified Pectoral Nerve Block Versus Serratus Plane Block

Start date: May 20, 2021
Phase: N/A
Study type: Interventional

In PECSII or modified PECSI block, local anesthetic (LA) is injected between pectoralis major muscle (PMm) and pectoralis minor muscle (Pmm) to block lateral and medial pectoral nerves and between pectoralis minor muscle (Pmm) and serratus anterior muscle in the anterior axillary line to block the intercostal nerves II-VI (Blanco et al., 2012). In Serratus anterior plane block (SAPB) local anesthetic (LA) is injected above the serratus muscle (between latissmus dorsi muscle and serratus muscle) or below the serratus muscle (between serratus muscle and 4th rib) in the mid-axillary line to block the intercostal nerves II-VI and spares the pectoral nerves (Blanco et al., 2013).

NCT ID: NCT04890197 Not yet recruiting - Breast Cancer Clinical Trials

Tahini and Dermatitis in Breast Cancer

Start date: May 8, 2021
Phase: N/A
Study type: Interventional

This study aimed to investigate the effect of tahini on acute radiation dermatitis in breast cancer (BC) patients undergoing radiotherapy (RT). 50 eligible BC patients will randomly assign to consume tahini 48 gr per day during and 1 week after RT or with no intervention (control group). The radiation dermatitis will be assessed weekly according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) scales.

NCT ID: NCT04890184 Not yet recruiting - Breast Cancer Clinical Trials

Grape Juice and Dermatitis in Breast Cancer

Start date: May 8, 2021
Phase: N/A
Study type: Interventional

This study aimed to investigate the effect of grape juice on acute radiation dermatitis in breast cancer (BC) patients undergoing radiotherapy (RT). 50 eligible BC patients will randomly assign to consume 100 gr of grape juice per day during and 1 week after RT or with no intervention (control group). The radiation dermatitis will be assessed weekly according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) scales.

NCT ID: NCT04879264 Not yet recruiting - Clinical trials for Breast Cancer Female

Sleep Disorders Prior to and During a Course of Radiotherapy for Breast Cancer

RADIO-SLEEP
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The main goal of the study is to evaluate sleep disorders in breast cancer patients prior to and during a course of radiotherapy in terms of severity of sleep disorders, distress for the patients and use of sleeping drugs, in order to evaluate the potential effect of habituation to radiotherapy during the course of treatment and generate hypotheses thereof. The patients will be asked to complete a questionnaire prior to radiotherapy, after 5 and 15 fractions of radiotherapy, and at the end of radiotherapy. The questionnaire includes questions regarding symptoms, distress, sleep disorders and sleeping drugs. In addition, a questionnaire regarding the use of smartphones / tablets will be completed prior to radiotherapy. Forty-eight patients with documented start of radiotherapy and with a documented completed questionnaire at baseline and at least one completed questionnaire after start of radiotherapy should be subjected to statistical analysis. Assuming that 5% of patients do not fulfil these requirements, a total of 51 patients should be enrolled to this study.

NCT ID: NCT04843358 Not yet recruiting - Breast Cancer Clinical Trials

Efficacy of Expressive Writing on Quality of Life Among Breast Cancer Survivors in Oman: A Double Blind Randomized Controlled Trial

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Background Breast cancer is the most common cancer affecting women globally. Additionally, it is the most common cause of cancer mortality among women. Internationally, breast cancer is the most frequently diagnosed cancer among women in 140 of 184 countries. Global registry surveys also demonstrate that the incidence of breast cancer will increase by 46% and affect more than 3,059,829 people by 2040. The rate of breast cancer deaths will increase by 58.3% and affect more than 356,225 women. Psychologically, it has been shown that emotional suppression experienced by some women with breast cancer is highly predictive of low quality of life and psycho-somatic morbidities during the process of treatment. Such attitude towards emotional suppression is thriving well in Arab societies where somatizing, as opposed to psychologizing, distress is prevailing proclivity. Expressive writing may provide a tool to meet such need. Taken together and given the lack of any study exploring EW effect of Quality of life in women with breast cancer. The current study aims to examine the impact of expressive writing on quality of life in a randomized controlled trial among cancer survivor in Oman. Hypothesis The primary hypothesis states that compared to writing about neutral topic, expressive writing intervention will lead to a better improvement in quality of life among breast cancer patients after two months of the intervention. Objectives To assess the efficacy of 3 sessions EWI versus Writing about neutral topic, on Quality of life of Breast Cancer Survivors at 1- and 2-month post intervention. Method This study is a multicenter, prospective, double blind, parallel RCT with a 2-month follow-up and will be carried out at Oman's comprehensive cancer care & research center and Sultan Qaboos University Hospital, Muscat, Oman. Sixty four participants will be randomized to 3 sessions EWI group or neutral topic writing group, using a fixed randomization schedule allocating participant between the two intervention arms in a 1:1 ratio.