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Breast Neoplasms clinical trials

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NCT ID: NCT05559411 Recruiting - Breast Cancer Clinical Trials

MEthods for LOcalization of Different Types of Breast Lesions

MELODY
Start date: January 1, 2023
Phase:
Study type: Observational

In the last decades, the proportion of breast cancer (BC) patients receiving breast-conserving surgery has increased steadily, reaching 70-80% in developed countries. Since positive resection margins are strongly associated with local recurrence risk, the goal of breast surgery is the complete tumor removal and most national and international guidelines recommend re-operation, either in form of re-excision or mastectomy, until clear margins have been reached. Re-operation rates vary widely, with population-based studies reporting a range of 15-35%, and the necessity for a second surgery can lead to increased patient anxiety, a delay in start of adjuvant treatment, worse cosmetic outcome and increased complication rates and costs. Therefore, re-operation rate has been included as a quality indicator in several countries. Several imaging-guided techniques have been developed to guide removal of non-palpable breast lesions, the oldest one being preoperative wire placement under ultrasound or mammographic guidance, usually followed by radiography or ultrasound of removed tissue. Newer techniques, such as intraoperative ultrasound (IOUS), radioguided occult lesion localization (ROLL), radioactive seed localization (RSL), radar reflector-localization (RRL), magnetic seed localization (MSL), and radiofrequency identification (RFID) tags have been introduced as an alternative to wire-guided localization (WGL). To date, comparative data on the rates of successful lesion removal, negative margins, re-operation rate and patient's comfort depending on the localization technique used are limited. Further, since some of these studies were funded by the manufacturer of the marker examined, a potential bias cannot be excluded. In the vast majority of the available studies, the patient's perspective with regard to discomfort and pain level has not been evaluated. The aim of the proposed study is to comparatively evaluate different imaging-guided localization methods used for surgical removal of malignant breast lesions with regard to oncological safety and patient-reported outcomes.

NCT ID: NCT05558917 Enrolling by invitation - Breast Cancer Clinical Trials

Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery

ESPECS
Start date: September 7, 2022
Phase: N/A
Study type: Interventional

The study aims to compare the efficacy of the two operating blocks PECS2 and ESP by measuring postoperative opioid consumption and, secondarily, to compare (between PECS and ESP) postoperative opioid consumption between surgery with/without axillary cavity dissection and with/without implantation of prosthesis or expansion

NCT ID: NCT05558722 Recruiting - Clinical trials for Breast Cancer Stage II

Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer

ACNTBC
Start date: November 30, 2022
Phase: Phase 2
Study type: Interventional

Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage human epidermal growth factor receptor 2 (HER2)-negative breast cancer. This study aims to evaluate the efficacy and safety of adding anlotinib to standard neoadjuvant chemotherapy in primary (HER2)-negative breast cancer. Patients aged 18 years or older with previously untreated stage ⅡB-IIIA histologically documented (HER2)-negative breast cancer were assigned to receive chemotherapy plus oral Anlotinib. The primary endpoint was pathologic complete response (pCR) (no invasive carcinoma in breast or axilla). Secondary end points included safety and disease-free survival (DFS).

NCT ID: NCT05557877 Recruiting - Breast Carcinoma Clinical Trials

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Start date: February 14, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial tests whether low-dose aspirin can affect markers of inflammation in postpartum (after childbirth) patients with benign breast disease planning to have a breast biopsy. Chronic inflammation may increase the risk of postpartum related breast cancer. Low-dose aspirin is a non-steroidal anti-inflammatory drug. Giving low-dose aspirin may affect markers of inflammation in blood and tissue and may prevent postpartum related breast cancer.

NCT ID: NCT05556200 Recruiting - Breast Cancer Clinical Trials

A Phase II Trial of Camrelizumab in Combination With Apatinib for Neoadjuvant Treatment of Early-stage TNBC With a High Proportion of TILs

Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

This is a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a VEGFR2 TKI) for neoadjuvant treatment of patients with triple-negative breast cancer and >10% tumor-infiltrating lymphocytes (TILs) in baseline breast tumors. We will enroll 58 subjects (Simon's two stage design). The study is designed to evaluate the efficacy and safety of camrelizumab in combination with apatinib in the neoadjuvant treatment of TNBC with a high proportion of TILs.

NCT ID: NCT05555706 Recruiting - Clinical trials for Triple Negative Breast Cancer (TNBC)

Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer

Start date: December 6, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This Phase II/III study assessed the efficacy, safety, pharmacokinetics, and immunogenicity of B013 administered with nab-paclitaxel in participants with locally advanced or metastatic triple negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

NCT ID: NCT05555251 Active, not recruiting - Clinical trials for HER2-positive Breast Cancer

BI-1607 in Combination With Trastuzumab in Subjects With HER2-positive Advanced Solid Tumors

CONTRAST
Start date: July 28, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

HER2+ breast and gastric cancer patients' survival is significantly improved by trastuzumab alone or in combination with chemotherapy. However, many patients remain uncured and develop resistance to trastuzumab resulting in relapse or progression of the disease. BI-1607, a human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) targets CD32b (Fc Gamma Receptor IIB), it is intended to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. This is a Phase 1/2a, first-in-human, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors whose tumor has progressed after standard therapy.

NCT ID: NCT05554354 Recruiting - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)

Start date: August 27, 2024
Phase: Phase 2
Study type: Interventional

This phase II ComboMATCH treatment trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread from where it first started to other places in the body (metastatic) and has an NF1 genetic change. Fulvestrant is a hormonal therapy that binds to estrogen receptors in tumor cells, resulting in estrogen receptor destruction and decreased estrogen binding, which may inhibit the growth of estrogen-sensitive tumor cells. Binimetinib is a targeted therapy that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of binimetinib to fulvestrant in breast cancers with an NF1 genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to fulvestrant alone.

NCT ID: NCT05553522 Recruiting - Brain Metastases Clinical Trials

Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer

Start date: January 29, 2024
Phase: Phase 1
Study type: Interventional

This research study will evaluate how well brain metastases associated with HER-2 positive breast cancer can be controlled using a type of radiation known as stereotactic radiosurgery (SRS) when combined with three therapeutic agents, tucatinib, capecitabine, and trastuzumab. The combined use of SRS with the three drugs is considered investigational.

NCT ID: NCT05552001 Recruiting - Clinical trials for Metastatic Breast Cancer

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer

ISIdE
Start date: October 5, 2023
Phase: Phase 3
Study type: Interventional

ISIdE is an European, multicentric study that aims to assess the efficacy of Sacituzumab Govitecan (SG) in locally advanced or metastatic triple-negative breast cancer where the disease has progressed despite chemotherapy or within 6 months after the end of curative treatments in order to: 1. evaluate the treatment efficacy in less pretreated patients. 2. identify biomarkers that could predict response or resistance to the drug. 100 patients will be included in this trial.