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Metastatic Breast Cancer clinical trials

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NCT ID: NCT06386263 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada

HER-TEMPO
Start date: April 26, 2024
Phase:
Study type: Observational

Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively. Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related outcomes in order to better represent the effectiveness of therapies in routine care settings.

NCT ID: NCT06383767 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer

Start date: June 30, 2024
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.

NCT ID: NCT06377852 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Start date: October 28, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with MBC (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs. The primary objective of the CDK Study is to compare TTD on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (AI or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors. Together with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing).

NCT ID: NCT06369831 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011

HERMIA
Start date: August 2024
Phase: Phase 2
Study type: Interventional

This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization (ISH) and imaging tools used for treatment response follow-up including Fluorodeoxyglucose F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography (ceCT).

NCT ID: NCT06369285 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

ALISCA-Breast1
Start date: December 31, 2024
Phase: Phase 2
Study type: Interventional

PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.

NCT ID: NCT06343987 Recruiting - Clinical trials for Metastatic Breast Cancer

The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity

Start date: February 19, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a physical activity program in patients with metastatic breast cancer and overweight receiving endocrine-based treatment. The aim of the study is to assess the feasibility and metabolic efficacy of a 12-week physical activity program in this patient group. The hypothesis is that improving metabolic health through physical activity can optimize cancer care. Participants will randomized 2:1 to either a physical activity program or care as usual.

NCT ID: NCT06343181 Recruiting - Clinical trials for Metastatic Breast Cancer

A Qualitative Study on Treatment Adherence in Patients With Metastatic Breast Cancer

Start date: October 3, 2022
Phase:
Study type: Observational

Qualitative observational study with the aim to explore medication adherence in a sample of patients with metastatic breast cancer. Patients with metastatic breast cancer receiving or having received oral oncologic therapy, and attending the Division of Medical Senology at the European Institute of Oncology, will be included and enrolled in this research project."

NCT ID: NCT06342037 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial

TONIC-3
Start date: May 15, 2024
Phase: Phase 2
Study type: Interventional

This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer.

NCT ID: NCT06338644 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.

Palbociclib
Start date: July 1, 2024
Phase:
Study type: Observational

Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies

NCT ID: NCT06328387 Recruiting - Clinical trials for Metastatic Breast Cancer

HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer

Start date: January 29, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Advanced breast cancer is a special subtype of human breast cancer. Conventional guidelines recommend chemotherapy combined with other adjuvant therapies for this subtype of patients. However, the choice of treatment for these patients after treatment progress is a research hotspot in this field. Trastuzumab Deruxtecan (T-DXd) and Sacituzumab Govitecan (SG) are new ADC drugs targeting HER2 or TROP-2 with high efficacy and low toxicity after the progress of first-line treatment. The autophagy agents hydroxychloroquine or chloroquine has become the only FDA (Food and Drug Administration) approved autophagy inhibitor, and hydroxychloroquine and antibody-drug conjugate(ADC) may have synergistic effects based on the previous work results of our research group. Therefore,we envisage that Trastuzumab Deruxtecan(T-DXd) or Sacituzumab Govitecan (SG) combined with hydroxychloroquine(HCQ) in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival. To this end, we intend to conduct a prospective,multi-center, phase I/II clinical trial to evaluate the efficacy and safety of T-DXd or SG in combination with HCQ in patients with advacned breast cancer.