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Hormone Receptor Positive Tumor clinical trials

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NCT ID: NCT05982093 Recruiting - Breast Cancer Clinical Trials

Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer

SOLTI-2104
Start date: October 3, 2023
Phase: Phase 2
Study type: Interventional

PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+/HER2-negative breast cancer with aiming at evaluating the biological effects of elacestrant with or without triptorelin.

NCT ID: NCT05759949 Active, not recruiting - Breast Cancer Clinical Trials

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Start date: March 29, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment. The study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).

NCT ID: NCT05735080 Recruiting - Breast Cancer Clinical Trials

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

INX-315-01
Start date: March 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. This study will evaluate approximately 6 dose levels of daily INX-315 in Part A, at least two dose levels will be evaluated in Part B to identify the Recommended Phase 2 Dose (RP2D) in patients with ovarian cancer, and Part C will evaluate combination treatment of INX-315 plus a CDK4/6i and selective estrogen receptor degrader (SERD) in HR+/HER2- breast cancer patients who have progressed on prior CDK4/6i regimen.

NCT ID: NCT05594095 Recruiting - Breast Cancer Clinical Trials

SNF Platform Study of HR+/ HER2-advanced Breast Cancer

Start date: December 30, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had previously used CDK4/6 inhibitors.

NCT ID: NCT05582499 Recruiting - Breast Cancer Clinical Trials

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

FASCINATE-N
Start date: November 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.

NCT ID: NCT04352777 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer

Start date: September 14, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to perform an in depth analysis of changes in the tumor immune microenvironment in patients undergoing treatment with standard of care endocrine therapy and abemaciclib in the advanced setting via singe cell RNA sequencing. The investigators will also correlate changes in serum estrogen levels to changes in tumor and peripheral immune cell repertoire and function (including regulatory T cell populations, B cells, myeloid-derived suppressor cell populations, T cell activation and T cell exhaustion).This study has two cohorts with 15 patients in each cohort.

NCT ID: NCT04161833 Completed - Breast Cancer Clinical Trials

Opera® for Aromatase Inhibitor-related Arthralgia Management (AIA)

AIA
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

In this phase II, multicenter, self-controlled clinical trial, we will evaluate the safety and efficacy of OPERA® for treating anti-aromate inhibitors (AIs) induced arthralgia. The diagnosis of arthralgia will be based on the NCI-CTCAE v4.0 grade of ≥ 1 , A disorder characterized by a sensation of marked discomfort in a joint, mild pain (grade 1). Arthralgia will be assessed at the enrollment and every two months until the sixth month.

NCT ID: NCT04134884 Completed - Clinical trials for Metastatic Breast Cancer

Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer

Start date: April 1, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase I study to test the safety of a combination of ASTX727 with talazoparib in patients with triple negative breast cancer or hormone resistant/HER2-negative metastatic breast cancer

NCT ID: NCT04088110 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer

Start date: November 2019
Phase: Phase 2
Study type: Interventional

This study is a single-arm, open-label, phase II study, comparing the efficacy and safety of pyrotinib plus trastuzumab and aromatase inhibitors, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor receptor 2) + MBC and inoperable LABC patients.

NCT ID: NCT03917082 Active, not recruiting - Clinical trials for Breast Cancer Female

Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer

LALEAST
Start date: September 23, 2019
Phase: Phase 2
Study type: Interventional

Phase II trial of 2 years of standard adjuvant endocrine therapy after low risk hormone receptor positive, HER2 negative, node negative breast cancer in women older than 50 at diagnosis. The study hypothesis is that reducing adjuvant endocrine therapy from 5 to 2 years in a population with low risk of breast cancer; as determined by histopathologic criteria and confirmed by low risk genomic analysis using Prosigna®; will be safe and acceptable to this population, and will not compromise the expected excellent breast cancer specific outcomes for this population.