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Breast Cancer clinical trials

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NCT ID: NCT05296746 Recruiting - Clinical trials for Breast Cancer Stage II

Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

RIBOLARIS
Start date: May 3, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole. This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting.

NCT ID: NCT05296577 Recruiting - Breast Cancer Clinical Trials

Anlotinib Combination With Vinorelbine in the HER2- Advanced Breast Cancer

Start date: March 22, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of anlotinib combined with vinorelbine in the treatment of HER2- advanced breast cancer.

NCT ID: NCT05294016 Recruiting - Breast Cancer Clinical Trials

Smart Bra for Diagnosing Breast Cancer

CBRA
Start date: April 13, 2022
Phase: N/A
Study type: Interventional

This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer.

NCT ID: NCT05293964 Recruiting - Breast Cancer Clinical Trials

Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer

Start date: May 18, 2022
Phase: Phase 1
Study type: Interventional

This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen receptor (ER) -positive, human epidermal growth factor receptor (HER-2) -negative locally advanced or metastatic breast cancer.

NCT ID: NCT05293470 Recruiting - Breast Cancer Clinical Trials

A Post Marketing Surveillance on Piqray in Korea

Start date: June 29, 2022
Phase:
Study type: Observational

This is a prospective, multicenter, open-label, non-comparative, non-interventional, observational study to assess te safety and effectiveness of Piqray in the real-world setting

NCT ID: NCT05292742 Recruiting - Breast Cancer Clinical Trials

Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer

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

To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pCR after neoadjuvant therapy

NCT ID: NCT05291507 Recruiting - Breast Cancer Clinical Trials

Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System

BreastMRgFUS
Start date: August 2, 2022
Phase: Early Phase 1
Study type: Interventional

This is an open-label, single arm, single center, non-randomized feasibility study of the Muse MRgFUS System in subjects with breast cancer. Subjects will undergo partial ablation of half (≤50%) of one of their tumors (if multifocal or multicentric disease) followed by surgical resection per standard of care. The partial tumor ablation design will ensure that no information is lost that would impact the subject's standard of clinical care. Because current care often includes testing on the tumor, retaining a portion of viable tumor is advised by the clinical team. To ensure viable tissue confirmation, patients will be enrolled in two cohorts as described in the protocol. The investigators will use imaging correlation, histological evaluation, and subject reported outcomes to assess the safety, tolerability, and efficacy of the Muse MRgFUS System. This proposed study will adhere to the guidelines of subjects receiving a timely tumor resection after diagnosis. All subjects will undergo the definitive procedure of surgical resection per standard of care. Surgical resection cannot be delayed as a result of the ablation and should occur within 6 weeks after the decision to proceed with surgical resection. In cases where a surgery may occur outside of the 6 week window, prior approval from the external DSMC should be obtained. While MRgFUS ablation is designed to be a breast-conserving technique, the investigators will enroll patients that are undergoing any surgical resection, including both lumpectomy or mastectomy. Both surgical procedures will allow assessment of the defined primary, secondary and exploratory objectives.

NCT ID: NCT05288777 Recruiting - Breast Cancer Clinical Trials

Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

Breast53
Start date: July 11, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and/or mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.

NCT ID: NCT05286684 Recruiting - Breast Cancer Clinical Trials

Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis (Exo-LCR)

Exo-LCR
Start date: January 4, 2023
Phase: N/A
Study type: Interventional

The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.

NCT ID: NCT05283330 Recruiting - Breast Cancer Clinical Trials

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

Start date: December 22, 2022
Phase: Phase 1
Study type: Interventional

A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors