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Breast Neoplasms 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: NCT06383663 Not yet recruiting - Breast Cancer Clinical Trials

Supraclavicular Lymph Node Dissection for Ipsilateral Supraclavicular Lymph Node Metastatic Breast Cancer

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis.

NCT ID: NCT06382948 Not yet recruiting - Clinical trials for Advanced Breast Cancer

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

ADELA
Start date: June 2024
Phase: Phase 3
Study type: Interventional

This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival. Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.

NCT ID: NCT06382142 Not yet recruiting - Clinical trials for Triple-Negative Breast Cancer

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

Start date: May 2024
Phase: Phase 3
Study type: Interventional

This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced or metastatic Triple-Negative breast cancer after taxane failure.

NCT ID: NCT06380816 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer

Start date: May 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells. The four main aims of the clinical trial are to find out: 1. The best dose of UCB4594 that can be given safely to participants in the trial. 2. What the side effects of UCB4594 are and how they can be managed. 3. What happens to UCB4594 inside the body and how it affects cancer cells. 4. Whether UCB4594 can cause cancer to shrink.

NCT ID: NCT06380751 Not yet recruiting - Clinical trials for Advanced Breast Cancer

Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

EvoPAR-BR01
Start date: April 18, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced 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: NCT06374459 Not yet recruiting - Clinical trials for Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer

Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

Start date: July 31, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC).

NCT ID: NCT06371807 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab

KEYPARTNER
Start date: July 2024
Phase: Phase 2
Study type: Interventional

Phase II, randomized, Active-controlled open label trial for treatment of high risk, HR-/HER2- (triple negative) breast cancer, with two sequences of neoadjuvant chemotherapy on a background of pembrolizumab