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Breast Cancer clinical trials

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NCT ID: NCT05465408 Recruiting - Breast Cancer Clinical Trials

Culturally Aware AET Non-Initiation Intervention

Start date: July 21, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the feasibility and acceptability of a brief, nurse-led intervention to support breast cancer survivors who have delayed initiation of hormonal therapy or who have concerns about starting hormonal therapy.

NCT ID: NCT05464667 Recruiting - Breast Cancer Clinical Trials

Preoperative Irradiation for Stage I Breast Cancer

Start date: July 7, 2023
Phase: N/A
Study type: Interventional

The novel use of preoperative RT will have broad implications for breast cancer patients, most of whom present with early-stage disease. In the era of reduced chemotherapy delivery, preoperative RT will allow oncologists to assess radiologic and biologic tumor response and correlate it to outcomes. Underutilization of RT negatively affects mortality. This trial aims to further evaluate pre-operative radiation therapy in patients with early stage, biologically favorable breast cancer, with improved access to RT.

NCT ID: NCT05464173 Recruiting - Breast Cancer Clinical Trials

Chidamide in Combination With Abemaciclib and Endocrinotherapy(Doctor's Choice) in Breast Cancer Patients Previously Treated With Palbociclib

CINDERELLA
Start date: July 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the efficacy and safety of chidamide in combination with abemaciclib and endocrinotherapy(doctor's choice) in locally advanced/metastatic HR+/HER2- breast cancer who had failed prior palbociclib therapy

NCT ID: NCT05464082 Recruiting - Clinical trials for Breast Cancer Recurrent

Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of TNBC

TOWARDS-II
Start date: January 6, 2023
Phase: Phase 2
Study type: Interventional

This is a prospective phase 2 study to use Functional Precision Oncology (FPO) to predict, prevent and treat early metastatic recurrence in subjects with HR-low/Her2 negative or triple negative breast cancer.

NCT ID: NCT05462457 Recruiting - Breast Cancer Clinical Trials

TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes

SenTa2
Start date: March 7, 2022
Phase:
Study type: Observational

Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0/Tis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated. The present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.

NCT ID: NCT05461768 Recruiting - Breast Cancer Clinical Trials

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors

Start date: August 9, 2022
Phase: Phase 1
Study type: Interventional

In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1. In phase Ib study, the safety and tolerability of BL-M07D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M07D1 in patients

NCT ID: NCT05460975 Recruiting - Breast Cancer Clinical Trials

Breast Cancer Risk From Sonographic Glandular Tissue Component (or International GTC Study)

Start date: November 1, 2022
Phase:
Study type: Observational

An international multicenter study to prospectively validate the association between sonographic GTC and subsequent breast cancer risk in women with dense breasts.

NCT ID: NCT05460780 Recruiting - Clinical trials for Breast Cancer Female

First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer

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

This study is a first in human, two-stage single arm non-comparative study of safety and performance. The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering chamber.

NCT ID: NCT05459064 Recruiting - Breast Cancer Clinical Trials

Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction

Start date: September 1, 2022
Phase:
Study type: Observational

The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months. All Motiva Flora® TE's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. After the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander. The study collects retrospective data on the use of the Motiva Flora TE, from patients who had a tissue expander-based-breast reconstruction using the Motiva Flora® TE since market introduction in May 2020.

NCT ID: NCT05458739 Recruiting - Breast Cancer Clinical Trials

The ClearCoast™ Magnetic Resonance Outcome PMS Study

Start date: June 24, 2021
Phase:
Study type: Observational

Post Marketing Surveillance (PMS) study. Up to 93 patients undergoing breast conserving surgery will be enrolled in a prospective, single center, non-randomized controlled study, and a corresponding number of historical patients that underwent BCS will serve as the historical control group, accounting for a 1:1 ratio. All study patients and the patients in the historical control group will be required to meet the study eligibility criteria. BCS will be performed with the routine standard of care (SOC), including intra-operative methods used to improve margin assessment. In addition to SOC process, the main specimen from patients found eligible will be scanned in the ClearCoast™ system. The surgeon will utilize the information from the ClearCoast images in his margin assessments evaluation which includes the diffusion at the surface of a particular aspect (suggesting irregular tissue at the specimen's surface), and decide whether to excise additional tissue. The decision-making process including MR images interpretation and the surgical decisions will be evaluated and documented. Following procedure, routine histopathology examination will be performed accompanied by the ClearCoast optical and parametric maps. This study is a controlled design, in which subjects previously having undergone BCS by the same surgeons, will serve as the historical control group, comparing the following endpoints: - Complete surgical re-excision rate - Total excised breast tissue volume The study Control group is composed of historical data from patients previously undergone BCS, under the same site SOC surgical practice, practicing surgeons, and study eligible criteria. This allows reducing inter-group variability and bias. A device operator trained by ClearCut Medical will operate the device throughout the study.