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Breast Neoplasms clinical trials

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NCT ID: NCT05504213 Recruiting - Breast Cancer Clinical Trials

A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer

Start date: January 12, 2022
Phase: Phase 1
Study type: Interventional

HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10352 plus fulvestrant in patients with hormone receptor (HR) positive, human epidermal growth factor 2 (HER2)-negative, advanced breast cancer (ABC) harboring PIK3CA mutations.

NCT ID: NCT05504148 Recruiting - Breast Cancer Clinical Trials

Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy

ProtECtion
Start date: March 29, 2021
Phase: N/A
Study type: Interventional

The potential cardiovascular toxicity of tumor treatment and its resulting cardiovascular events have gradually become an important health risk for tumor survivors. Prevention and early identification of cardiovascular toxicity has now become one of the bottlenecks in improving the prognosis of cancer patients. Compared to conventional echocardiographic indicators, new ultrasound technology based on speckle tracking imaging (STI) has shown superiority in the diagnosis, risk stratification and prognosis evaluation of cardiovascular diseases. Crocin, one of the main active components of saffron, has been found protective effect on cardiovascular toxicity in basic studies. This is a randomized, double-blind, placebo-controlled, single-center clinical study to observe the effect of crocin on cardiovascular function caused by breast cancer treatment. One hundred and twenty breast cancer patients planning to undergo radiotherapy or chemotherapy will be included and randomly divided into a crocin group and a placebo group to observe the effect of total saffron tablets on cardiovascular function in patients with early breast cancer radiotherapy and chemotherapy. Participants will take crocin or placebo (4 tablets/time, 3 times a day) during each cycle of chemotherapy for 8 days, started on the 1st day before radiotherapy/chemotherapy. Follow-up was performed every 3 months after enrollment, and the follow-up period was 6 months. Primary study endpoints include the differences between groups in the difference in LVEF and GLS measured by echocardiography at the end of the experiment compared to baseline. Secondary study endpoint include the differences in the incidence rates of serum troponin exceeding the upper limit of normal value and NT-proBNP higher than the normal age reference value, the frequency and duration of chest tightness, chest pain and palpitation, the degree of arrhythmia and ST-T changes displayed by dynamic electrocardiogram, the other echocardiographic parameters (the E/e', global circumferential strain, global radial strain, 3D-GAS, LV torsion, LV rotation/derotation velocity, SDI, RVFWS, and indexes of left ventricular diastolic function and right ventricular function) at the end of the experiment compared to baseline between the two groups.

NCT ID: NCT05502224 Recruiting - Breast Cancer Clinical Trials

Multidisciplinary Approach to Fatigue

Start date: August 19, 2022
Phase: N/A
Study type: Interventional

Prospective longitudinal, single-center, non-randomized study for the implementation of an integrated multidisciplinary fatigue follow-up for young patients with breast cancer or germ cell tumour

NCT ID: NCT05501886 Recruiting - Breast Cancer Clinical Trials

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

VIKTORIA-1
Start date: September 30, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

NCT ID: NCT05501704 Recruiting - Male Breast Cancer Clinical Trials

ETHAN - ET for Male BC

Start date: October 11, 2023
Phase: Phase 2
Study type: Interventional

This research study is looking to see how well male breast cancer responds to preoperative treatment with endocrine therapy and which endocrine therapy regimen is the most effective treatment for male breast cancer. The drugs used in this study are: - Tamoxifen - Anastrozole - Degarelix - Abemaciclib

NCT ID: NCT05498311 Recruiting - Breast Cancer Clinical Trials

Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

IORT_BREAST
Start date: October 20, 2016
Phase: Phase 2
Study type: Interventional

To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy

NCT ID: NCT05494502 Recruiting - Chronic Pain Clinical Trials

Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients

Start date: May 23, 2023
Phase: N/A
Study type: Interventional

Chronic postsurgical pain (CPSP) has an incidence of 46% in patients after breast cancer surgery, which seriously affects patients' physiological and psychological function, as well as quality of life. Acute pain is an independent risk factor for persistent pain after surgery. Erector spinae plane block (ESPB) provided excellent perioperative analgesia in patients undergoing breast surgery. Dexmedetomidine as an adjuvant of local anesthetics prolongs the duration of peripheral nerve block and decreases the requirements of postoperative analgesia. The investigators hypothesize that, for breast cancer patients undergoing mastectomy, ESPB (with a combination of 0.5% ropivacaine 35 ml and dexmedetomidine 1 microgram/kg) can reduce the occurrence of CPSP. The purpose of this randomized controlled trial is to investigate the impact of ESPB with adjuvant dexmedetomidine on the incidence of CPSP in breast cancer patients after mastectomy. We will also observe the impact of ESPB on long-term survival in these patients.

NCT ID: NCT05494281 Recruiting - Pain, Postoperative Clinical Trials

Serratus Anterior Plane Block to Prevent Chronic Postoperative Pain in Breast Cancer

USB22
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem. The hypothesis of this trial is that a peripheral block of the serratus anterior plane block type preoperatively after a modified radical mastectomy makes it possible to reduce the intensity and incidence of chronic post-surgical pain in breast cancer.

NCT ID: NCT05491395 Recruiting - Breast Cancer Clinical Trials

Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction

PROMART
Start date: June 27, 2022
Phase: N/A
Study type: Interventional

RATIONALE: Radiotherapy (RT) can be indicated to patients submitted to breast-conserving surgery, but, despite the benefits, adjuvant RT can cause contracture generated by tissue fibrosis in patients with immediate prosthetic reconstruction, which could cause prosthesis loss. The biological explanation of this outcome is not fully understood, but recent advances in the analysis of patient-derived blood can contribute to establishing a connection of molecular alterations related to this clinical outcome. There is not a consensus about using hypofractionated RT schemes for patients with BCS and breast reconstruction since no studies had investigated the reasons why some patients lose the prosthesis. PURPOSE: This study will evaluate G3 toxicity rate in breast cancer patients with immediate prosthetic reconstruction, submitted to hypofractionated radiotherapy, analyzing capsular contracture, leakage, infection, and bad positioning in order to demonstrate the noninferiority of Hypo-RT with the conventional RT. Additionally, the molecular profile of blood samples will be investigated in order to find biomarkers related to inflammations processes and response to treatment.

NCT ID: NCT05491226 Recruiting - Breast Cancer Clinical Trials

Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

Start date: November 17, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label prospective, single institution, Phase II study of pembrolizumab in combination with radiation therapy and CSF-1R inhibition in patients with high-risk TNBC. The primary objective is to assess the pathologic complete response (pCR) rate where pCR is defined as the absence of invasive disease in the breast and lymph nodes at the time of standard of care (SOC) treatment. Secondary objectives include evaluating the change in tumor infiltrating lymphocytes (TILs), safety and tolerability of the combination, progression-free survival, event-free survival, overall survival, and node clearance.