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Advanced Breast Cancer clinical trials

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NCT ID: NCT06290466 Completed - Clinical trials for Advanced Breast Cancer

Clinical Study on Pharmacokinetics of FCN-437c Capsule and Its Effect on QT Interval in Healthy Subjects

Start date: November 11, 2022
Phase: Phase 1
Study type: Interventional

This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule. This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control. This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation.

NCT ID: NCT06098599 Completed - Clinical trials for Advanced Breast Cancer

Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer

Start date: May 17, 2022
Phase: Phase 1
Study type: Interventional

A multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence study comparing the pharmacokinetic profile of LY01612 (Doxorubicin hydrochloride liposome injection) and CAELYX® in Chinese subjects with advanced breast cancer

NCT ID: NCT05812326 Completed - Clinical trials for Advanced Breast Cancer

PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer

Start date: May 17, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This exploratory clinical study aims to assess the safety and preliminary efficacy of an immunotherapy using PD-1 knockout anti-MUC1 CAR-T cells in the treatment of advanced MUC1-positive breast cancer

NCT ID: NCT04436393 Completed - Clinical trials for Advanced Breast Cancer

Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer

GRECO-B
Start date: July 2, 2020
Phase:
Study type: Observational

The purpose of this study is to observe the routine clinical care of patients who have been diagnosed with breast cancer and have undergone Guardant360 testing.

NCT ID: NCT04420598 Completed - Brain Metastases Clinical Trials

DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease

DEBBRAH
Start date: May 25, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter, international, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial

NCT ID: NCT04408118 Completed - Clinical trials for Metastatic Breast Cancer

First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC

ATRACTIB
Start date: October 5, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate to evaluate the efficacy and safety of first line atezolizumab in combination with paclitaxel and bevacizumab (Avastin®) in patients with advanced or metastatic triple-negative breast cancer (mTNBC)

NCT ID: NCT04097756 Completed - Clinical trials for Advanced Breast Cancer

A Phase I Study of LX-039 Tablets

Start date: January 7, 2020
Phase: Phase 1
Study type: Interventional

This is a phase I dose escalation and expansion study in patients with ER+, HER2- advanced breast cancer to explore the tolerance, PK/PD(pharmacokinetics/pharmacodynamics) profiles and preliminary anti-tumor activity of different doses of LX-039 tablets. The trial consists of two parts, dose escalation and dose expansion. Part 1 is the dose escalation phase with initial 6 dose groups, and "3 + 3" design is used to explore MTD of the drug; Part 2 is the dose expansion phase with 2 ~ 3 doses selected for expansion according to the escalation results of Part 1, and more subjects are enrolled to further observe the tolerance and preliminary anti-tumor activity of the drug. After the completion of dose expansion, the recommended phase II dose (RP2D) will be determined after discussion based on the obtained tolerance and PK/PD data.

NCT ID: NCT03878823 Completed - Clinical trials for Metastatic Breast Cancer

Safety and Pharmacokinetics of ODM-209

STESIDES
Start date: April 17, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.

NCT ID: NCT03829306 Completed - Clinical trials for Advanced Breast Cancer

Unraveling KAdcyla Resistance In Human Epidermal Growth Factor Receptor 2(HER2) Positive Advanced Breast Cancer (KATIA)

KATIA
Start date: June 12, 2018
Phase:
Study type: Observational

The study aim is to perform a comprehensive and integrated characterization of mechanisms of primary and acquired resistance to Kadcyla in a prospective cohort of progressive/recurrent HER2-positive breast cancer patients.

NCT ID: NCT03809988 Completed - Breast Cancer Clinical Trials

PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)

PALMIRA
Start date: April 5, 2019
Phase: Phase 2
Study type: Interventional

Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)