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Breast Neoplasms clinical trials

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NCT ID: NCT05234021 Completed - Clinical trials for HER2-positive Breast Cancer

HER2-directed Biosimilar in Breast Cancer: Real World ePRO

OGIPRO
Start date: December 14, 2021
Phase:
Study type: Observational

This project will engage anti-HER2 directed Trastuzumab biosimilar with a novel quality of ePRO and enable comparison of reliable reference real world patient data, thereby creating a basis for analytic research in order to promote the quality and efficiency of treatment

NCT ID: NCT05233800 Recruiting - Insomnia Clinical Trials

mHealth for Breast Cancer Survivors With Insomnia

Start date: April 5, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to determine the impact of the voice-activated smart speaker CBT-I components on insomnia symptoms among breast cancer survivors using a randomized clinical trial.

NCT ID: NCT05233696 Withdrawn - Clinical trials for Metastatic Breast Cancer

Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC

Start date: January 4, 2022
Phase: Phase 2
Study type: Interventional

Patients with locally advanced unresectable or metastatic programmed cell death ligand (PD-L1) positive triple negative breast cancer (TNBC) will be treated with radiation to one-four sites of metastasis amenable to radiation (sites of disease to be selected at the discretion of the treating radiation oncologist) followed by initiation of systemic therapy with pembrolizumab plus nab-paclitaxel/paclitaxel. Patients will be treated with pembrolizumab plus nab-paclitaxel/paclitaxel within 7 days of completion of radiation. Repeat imaging of all sites of disease will be performed every 9 weeks and response will be assessed according to RECIST 1.1.

NCT ID: NCT05232084 Completed - Breast Cancer Clinical Trials

Different Volumes of Erector Spinae Plane Block for Breast Surgery

Start date: January 27, 2022
Phase: N/A
Study type: Interventional

Postoperative pain is an important issue in female patients underwent breast surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a relatively novel interfascial block that was defined by Forero et al. It has been reported that ESPB provides effective analgesia management for several breast surgeries.

NCT ID: NCT05232006 Not yet recruiting - Clinical trials for Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers

PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers

PALB2-PARPi-01
Start date: May 2022
Phase: Phase 2
Study type: Interventional

The study aims at exploring the potential benefit of a PARP-inhibitor, Niraparib, in metastatic breast cancer developing in germline-PALB2 mutations carriers. This study is designed as a multicentre one-arm two-stage phase 2 clinical trial

NCT ID: NCT05231863 Recruiting - Breast Cancer Clinical Trials

Tyrosine Kinase Inhibitors (TKIs) in Trastuzumab Emtansine (T-DM1) Resistant HER2-positive Metastatic Breast Cancer: A Real-world Study

Start date: August 1, 2019
Phase:
Study type: Observational

This is a real world study to evaluate the efficacy and safety of tyrosine kinase inhibitors after T-DM1 progression.

NCT ID: NCT05230810 Recruiting - Clinical trials for HER2-positive Metastatic Breast Cancer

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

Start date: August 25, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.

NCT ID: NCT05228951 Recruiting - Breast Cancer Clinical Trials

Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in Combination for Stage II-III TPBC

Start date: February 10, 2022
Phase: Phase 2
Study type: Interventional

NOAH study confirmed that trastuzumab combined with chemotherapy can significantly improve PCR compared with chemotherapy alone, and established the status of trastuzumab as a new adjuvant targeted therapy. The emergence of CDK4/6 inhibitors has brought hope to breast cancer patients resistant to endocrine therapy. studies have shown that pyrotinib maleate combined with CDK4/6 inhibitor can significantly inhibit the proliferation of HER2 positive breast cancer cell lines, reduce the activation of pAKT and pHER3, inhibit cell arrest in G0-G1 phase, and increase cell apoptosis. In the mouse model, pyrotinib maleate combined with CDK4/6 inhibitor exhibits higher anti-tumor activity than any anti-tumor drug alone. Moreover, the toxicity of the combined therapy does not increase compared with monotherapy. This provides a good preclinical model for the treatment of breast cancer by pyrotinib maleate combined with CDK4/6 inhibitor. In addition, NeoALTTO study、CALGB 40601 study、NSABP B-41 study confirmed that the clinical efficacy of lapatinib combined with trastuzumab combined chemotherapy was better than that of lapatinib or trastuzumab single target treatment group. Therefore, it is envisaged that the combination of pyrotinib maleate and dalpiciclib combined with letrozole on the basis of adding new trastuzumab to treat triple positive breast cancer will further improve the curative effect. In conclusion, we believe that pyrotinib maleate combined with trastuzumab, dalpiciclib and letrozole can provide better strategies for neoadjuvant therapy in patients with II-III three positive breast cancer.

NCT ID: NCT05228210 Terminated - Breast Cancer Clinical Trials

Breast Cancer Self-Efficacy Scale for Partners

BCSES-P
Start date: September 1, 2019
Phase:
Study type: Observational

The concept of self-efficacy is a major predictor of physical, psychological, social and overall quality of life (QoL) among breast cancer survivors (BCS). Because survivor and partner outcomes are often linked, it is reasonable to hypothesize that self-efficacy is an important predictor of physical, psychological, social and overall QoL in partners as well. However, this hypothesis has yet to be tested, in part because no scale exists to measure cancer-related self-efficacy in partners. Development and psychometric testing of such a scale is a critical first step in developing a theoretical model predicting QoL in this population. Partners of BCS often report lower QoL compared to partners of healthy women, making them an important focus of research. During the award period, the applicant will follow standard instrument development procedures to develop the Breast Cancer Self-Efficacy Scale for Partners (BCSES-P) and test the scale's psychometric properties using a large and diverse sample of partners of breast cancer survivors.

NCT ID: NCT05227664 Recruiting - Clinical trials for Metastatic Triple-negative Breast Cancer

A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer

Start date: March 23, 2022
Phase: Phase 2
Study type: Interventional

This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK117/AK112 administered with chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).