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Breast Neoplasms clinical trials

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NCT ID: NCT04972448 Not yet recruiting - Breast Cancer Clinical Trials

RecurIndex Predicts Risk of Recurrence in Early-stage Luminal Breast Cancer

Start date: July 2021
Phase:
Study type: Observational

This study will conduct a multicenter, open, prospective clinical trial to observe the RecurIndex to assist in predicting the risk of recurrence in patients with early-stage Luminal-type breast cancer. The aim of this study is to validate the predictive effect of the RecurIndex on the risk of recurrence in women with early-stage Luminal-type breast cancer in China.

NCT ID: NCT04963608 Not yet recruiting - Clinical trials for HER2-positive Advanced Breast Cancer

RWS of Inetetamab HER2 Positive Advanced Breast Cancer

Start date: July 2021
Phase:
Study type: Observational

This non-Interventional study will describe and analyze the clinical use of Inetetamab in clinical practice in the treatment of HER2 positive advanced breast cancer in the real world.

NCT ID: NCT04963595 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

Pyrotinib and Vinorelbine Tartrate Capsules With or Without Inetetamab for First Line Treatment in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer

Start date: August 1, 2021
Phase: Phase 2
Study type: Interventional

Trastuzumab resistance, which is a common therapeutic challenge in HER2 positive metastatic breast cancer, is not fully understood. Pyrotinib is an oral tyrosine kinase inhibitor targeting EGFR, HER-2 and HER-4 receptors. More general inhibition of ErbB family with pyrotinib could provide additional benefit. Inetetamab could bind to HER2 extracellular domain (ECD) with high affinity and inhibit proliferation of multiple HER2-overexpressing cancer cell lines as a single agent or in combination with trastuzumab. This study is designed to evaluate the efficacy and safety of pyrotinib and vinorelbine tartrate capsulesin with or without Inetetamab for first line treatment in patients with HER2 positive metastatic breast cancer who had early failure on or after trastuzumab treatment.

NCT ID: NCT04946227 Not yet recruiting - Breast Cancer Clinical Trials

Pembrolizumab and Paclitaxel in Hormone Receptor-positive, hyperMUTATted Metastatic Breast Cancer Identified by Whole exOme sequeNcing ('MUTATION2')

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

Abbreviated Title :Pembrolizumab with paclitaxel in hypermutated breast cancer Trial Phase: Phase II Clinical Indication: Hormone receptor-positive metastatic breast cancer Trial Type: Interventional Type of control: None Route of administration: Intravenous Trial Blinding: None Treatment Groups : Pembrolizumab plus paclitaxel Number of trial participants: Approximately 200 patients will be prescreened with whole exome sequencing. Then 52 patients will be enrolled in the treatment phase. Estimated enrollment period :12 months Estimated duration of trial :The sponsor estimates that the trial will require approximately 24 months from the time the first subject signs the informed consent until the last subject's last visit. Duration of Participation :24 months Estimated average length of treatment per patient :8 months

NCT ID: NCT04942899 Not yet recruiting - Metastasis Breast Clinical Trials

Letrozole Plus Metronomic Capecitabine as First-line Treatment for Patients With Recurrent or Metastatic Breast Cancer

Start date: August 30, 2023
Phase: Phase 2
Study type: Interventional

The study is designed to assess the treatment outcomes following treatment with letrozole plus metronomic capecitabine in patients with hormone receptor-positive, Her2-negative advanced breast cancer who have not received prior systemic anti-cancer therapies for their recurrent /metastatic disease.

NCT ID: NCT04932460 Not yet recruiting - Breast Neoplasms Clinical Trials

Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy

Asclepius
Start date: June 15, 2021
Phase: N/A
Study type: Interventional

False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. But radioisotope is still not approved in China and can cause radiocontamination. A novel dual-tracer which can decrease the FNR in patients after neoadjuvant therapy is urged to be explored. Contrast enhanced ultrasonography (CEUS) can make the lymphatic drainage path and sentinel lymph nodes visible. Retrospective studies found that CEUS can locate SLN precisely. So this clinical trial aim to evaluate FNR, detective rate and numbers of SLN by using CEUS combined with blue dye as dual-tracer in sentinel lymph node biopsy in breast cancer patients after neoadjuvant therapy and the accuracy of CEUS for the diagnosis of lymph node metastasis before and after neoadjuvant therapy.

NCT ID: NCT04930692 Not yet recruiting - Breast Neoplasms Clinical Trials

A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"

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

The main hypothesis of this study is that contrast-enhanced CT lymphography can be used for preoperative visualization of sentinel lymph nodes in breast cancer patients. We assume that CT lymphography is a high-sensitivity and high-specificity method for sentinel lymph nodes' mapping in breast cancer patients. We also assume that positive predictive value and negative predictive value for identification of presence or absence of metastases in sentinel lymph nodes (SLN) will be high enough for preoperative diagnosis of SLN metastases in breast cancer patients. This study will use CT lymphography with periareolar injection of iopamidol and standard protocols of sentinel lymph nodes biopsy using intraoperative indocyanine green (ICG) fluorescence.

NCT ID: NCT04929548 Not yet recruiting - Breast Cancer Clinical Trials

Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP

Start date: January 5, 2022
Phase: Phase 4
Study type: Interventional

This study is a single-arm, single-center exploratory clinical study. Twenty patients with early-stage HER2-positive breast cancer are planned to be included, and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab + pertuzumab.

NCT ID: NCT04922008 Not yet recruiting - Breast Cancer Clinical Trials

Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS-C/D)

Start date: July 1, 2021
Phase: Phase 2
Study type: Interventional

This is an open label, phase II study evaluating the efficacy and safety of trastuzumab combined with oral chemotherapy (capecitabine or vinorelbine) in patients with HER-2 positive stage I breast cancer.

NCT ID: NCT04913571 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Tislelizumab in Combination With Eribulin for Patients With Metastatic Previously heaviLy-treAted TriplE-negative Breast Cancer:A Prospective Multiple-center Phase II Study

TEMPLATE
Start date: May 27, 2021
Phase: Phase 2
Study type: Interventional

Triple-negative breast cancer (TNBC) lacks effective treatment options due to the absence of traditional therapeutic targets.This study is a multicentre, prospective trial. The primary objective of the trial was to evaluate the objective response rate to tslelizumab combined with eribulin in different subgroups(subgroup A: TMB High, B: PD-L1 positive,C, immunomodulatory (IM),D,NanoString superiority,E,other types)of relapse or metastasis TNBC after failure of second-line chemotherapy. Therefore, exploring new therapeutic options and identifying subgroups of patients who may benefit from special treatments has been a focal point of research. Doing so, we expect to guide new investigation efforts in this area.