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BRCA Mutation clinical trials

View clinical trials related to BRCA Mutation.

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NCT ID: NCT06395519 Recruiting - Breast Cancer Clinical Trials

A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies

ERADIC8
Start date: May 2024
Phase: Phase 1
Study type: Interventional

This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.

NCT ID: NCT06177171 Recruiting - BRCA1 Mutation Clinical Trials

Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors

Start date: February 7, 2024
Phase: Phase 1
Study type: Interventional

This is a single center, phase I/Ib clinical trial evaluating the combination of the poly adenosine diphosphate-ribose polymerase (PARP) inhibitor olaparib with the DNA methyltransferase (DNMT) inhibitor ASTX727, which is an oral formulation of decitabine with cedazuridine (a cytidine deaminase inhibitor that allows for oral administration). The study population consists of adults with advanced/metastatic solid tumor malignancies with germline or somatic mutations in the HRR pathway (i.e., BReast CAncer gene 1 (BRCA1), BReast CAncer gene 2(BRCA2), Partner And Localizer of BRCA2 (PALB2), ATM, and/or Checkpoint kinase 2 (CHEK2) mutations).

NCT ID: NCT05769517 Recruiting - Ovarian Cancer Clinical Trials

PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES

Start date: March 20, 2023
Phase:
Study type: Observational

The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases: Retrospective phase AIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis; Prospective phase AIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study.

NCT ID: NCT05692596 Recruiting - Clinical trials for Pancreatic Ductal Adenocarcinoma

The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics

Start date: October 6, 2022
Phase:
Study type: Observational

The long-term goal of our PIC is to develop effective strategies that can be applied clinically at the point-of-care to prevent, intercept, or detect PDAC at an early stage, thereby reducing PDAC burden and saving lives.

NCT ID: NCT05554211 Recruiting - Breast Cancer Clinical Trials

Tranexamic Acid Usage in Bilateral Mastectomy to Reduce Post-surgical Drainage

Start date: July 12, 2022
Phase: Phase 2
Study type: Interventional

Tranexamic acid (TxA) is a drug that was approved by the FDA in 1986. It is an antifibrinolytic drug - this means that it is used to promote blood clotting by preventing the breakdown of blood clots that the participant's body naturally forms. TxA is very commonly used to control bleeding in a variety of surgeries, such as orthopedic and gynecologic procedures, and is available in both the injectable (delivering the drug through the veins) and oral forms. However, its use is still not commonplace in the setting of elective breast surgery, because it hasn't been extensively studied in this field. Because it is not currently FDA-approved for use in elective breast surgery, this would make the drug "investigational" for this study. Because of its current use in other fields, TxA seems to have a great deal of potential in reducing the amount of post-operative time that breast drains need to be kept in place, the frequency of adverse events during wound healing such as bleeding and fluid accumulation, and overall fluid drainage amount. This would serve to improve the overall process of post-operative healing following a mastectomy procedure. Currently, the use of TxA is approved through the injectable route at Northwestern, but it is not approved for administration by the topical route. Previous studies have shown that TxA given through the topical route of administration in breast reduction surgery reduced post-surgical drainage and fluid accumulation. In this study, the use of 3% (3 grams of TxA in 100 ml of saline) TxA through the topical route by applying it to the breast wound of one breast as a direct fluid irrigation will be investigated. This will be done as a fluid wash, where the TxA will be in a syringe, and just before wound closure the TxA will be sprayed onto the wound site. The other breast will undergo the same procedure, but will receive normal saline solution instead of TxA. The procedure of interest here is a prophylactic bilateral mastectomy, which is a mastectomy that is performed to prevent the occurrence of breast cancer. The purpose of this study is to test whether applying TxA topically during wound closure in mastectomy procedures will affect the quantity of fluid accumulation and bleeding, and the amount of time that post-operative drains need to be kept in place.

NCT ID: NCT05485766 Recruiting - Breast Cancer Clinical Trials

Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

Start date: February 29, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase II, single-arm, open label study to evaluate Olaparib plus Pembrolizumab following platinum-based chemotherapy plus Pembrolizumab as neoadjuvant therapy for germline BRCA (gBRCA) 1/2 mutated triple negative breast cancer (TNBC). Pembrolizumab in combination with weekly paclitaxel and carboplatin (treatment 1) is followed by Pembrolizumab in combination with Olaparib (treatment 2) in neoadjuvant setting and Pembrolizumab in combination with Olaparib in adjuvant setting will be studied

NCT ID: NCT05456919 Recruiting - Sexual Dysfunction Clinical Trials

Quality of Sexual Function in BRCA Mutated Women

BRCA_SFQ28
Start date: July 15, 2022
Phase:
Study type: Observational

Quality of sexual function in BRCA mutated women is investigated using SFQ28 questionnaire.

NCT ID: NCT04651933 Recruiting - Clinical trials for Epithelial Ovarian Cancer

A Training Set for the HRD Model in EOC

Start date: November 26, 2020
Phase:
Study type: Observational

A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. A LOH-HRD model is to be constructed based on the genetic testing in these patients. The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.

NCT ID: NCT03415659 Recruiting - Clinical trials for Advanced Solid Tumors

Phase I Clinical Study of HWH340 Tablet in Patients With Advanced Solid Tumors

Start date: March 5, 2018
Phase: Phase 1
Study type: Interventional

This is an open-label, dose-escalation/dose-expansion, phase I clinical trial study to investigate the safety, tolerability, and efficacy of HWH340. In addition, the pharmacokinetic characteristics will also be investigated. Three parts are included in this study.

NCT ID: NCT01329068 Recruiting - Breast Cancer Clinical Trials

Patient Empowerment by Group Medical Consultations

GMC
Start date: April 2011
Phase: N/A
Study type: Interventional

Carriers of a BRCA mutation have a significantly increased risk to develop breast cancer in the course of their lives . They face a difficult choice: either a preventive removal of the breast(s) or an intensive inspection process. After primary treatment of breast cancer, patients will be followed for 5-10 years to diagnose recurrence or a new primary tumor in an early stage; to support the patient during hormonal treatment; to educate the patient about risk factors and healthy life style; and to provide psychosocial support. Currently, follow-up of breast cancer patients and surveillance of BRCA mutation carriers is offered in regular, one-to-one medical visits. Experience shows that in an individual visit it is often not possible to give all aspects that are important, enough attention. The group medical consultation (GMC) is a new form of medical visits where the physician or nurse practitioner performs a series of one-to-one consultations in the presence of 8 to10 other patients. A social worker accompanies this process. Patients in group consultations may gather more information because they learn from each other and there is relatively more time compared to a regular consultation. Research shows that both patients and caregivers are more satisfied with care after a group consultation compared to individual visits. After a GMC the participants from the breast cancer GMCs will be provided with a dedicated iPad for 3 months. Using this iPad, patients can contact the women they have met during the GMC as well as health care professionals by several communication channels, including virtual group meetings. This approach provides a unique combination of both social support and professional education concerning survivorship in an e-health environment.However, it is also known that group sessions may be counterproductive for some patients, for example because they are frightened by the stories of others. The goal of this study is to examine whether group visits (in combination with dedicated iPads) are beneficial to women with a BRCA mutation and for patients in follow-up after breast cancer.