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25 active trials for Estrogen Receptor Positive Breast Cancer

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

Start: June 2017

Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

Start: August 2018

[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial

This protocol is a companion imaging study that will add FES-PET/CT imaging to the FORESEE trial at HCI. This study will establish the feasibility of using FES-PET/CT imaging to guide therapeutic decision making for functional precision oncology trials. The unique ability of FES-PET/CT to show absence of functional estrogen receptors throughout the entire body may improve confidence among research oncologists that an ER+ metastatic breast cancer patient is truly refractory to hormonal therapies which is a critical determination in the study design of the FORESEE trial.

Start: April 2021

Personalised Disease Monitoring in Metastatic Breast Cancer

Patients with metastatic breast cancer may respond well to treatment and metastases can remain stable for several years. Despite personalised medicine being increasingly used for diagnosis and treatment, follow-up still include radiological response evaluation every 3-4 months, which renders a significant number of 'unnecessary' exams for patients with long-term stable disease. Increasing evidence indicates that tumour markers such as circulating tumour DNA (ctDNA), thymidine kinase 1 (TK1) and cancer antigen 15-3 (CA15-3) may be useful for disease monitoring in the metastatic setting. However, algorithms that accurately define the time-points at which imaging can be foregone or reinstituted when progression is forecast, have not been developed. This study will measure ctDNA, TK1 and CA15-3 at all imaging time-points. The primary aim is to develop an algorithm based on these biomarkers, alone or in combination, that with sufficient specificity and sensitivity can advise whether a scan can be safely admitted at a specific time-point, for patients with MBC receiving first line therapy with AI plus cyclin dependent kinase 4/6 inhibitor (CDK4/6i). Additional samples will be stored such that novel biomarkers can also be tested in future. The cost-effectiveness of using the devised biomarker protocol will be evaluated.

Start: May 2019

Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer

This is a two stage study, with an initial dose escalation phase I study and subsequent double blind randomised phase II controlled trial. Eligible patients are post-menopausal women with metastatic ER+ breast cancer not suitable for surgical resection. Patients should be suitable for endocrine treatment, but have received no more than 3 previous lines of endocrine treatment and up to 1 line of chemotherapy for metastatic disease. They will also have had progressive disease during treatment with an aromatase inhibitor. Following the dose-escalation in stage 1, patients will be randomised to receive fulvestrant plus either placebo or 480mg (or maximum tolerated dose) of AZD5363 oral capsules or tablets taken once daily. Patients will receive fulvestrant in combination with either placebo or AZD5363 until disease progression. Patients may continue to receive fulvestrant and AZD5363/placebo treatment even after the last trial visit.

Start: May 2014

A Study of VLS-101 in Patients With Solid Tumors

This is a Phase 2 study evaluating the efficacy, safety, pharmacokinetics, immunogenicity, and pharmacodynamics of VLS-101 in patients with metastatic solid tumors. VLS-101 is an antibody- drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1) on cancer cells.

Start: October 2020

Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors

This randomized pilot trial studies how well an exercise intervention works in preventing breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to respond to inflammation more proficiently, helping to prevent primary and recurrent breast cancer.

Start: September 2014

A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older

The purpose of this research study is to evaluate a decision aid to help women aged 70 and older decide on treatment for their breast cancer.

Start: July 2016

Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca

This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced HER2-negative breast cancer. The primary efficacy objective is to determine if the immunotherapy increases the presence and percentage of tumor and/or stromal area of infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. Efficacy will be evaluated in 2 cohorts based on hormone receptor status.

Start: January 2017

Phase II Study of Everolimus Beyond Progression

This phase II trial studies how well everolimus and hormone therapy work in treating patients with hormone receptor positive breast cancer that has continued to spread (progressed) or returned after a period of improvement (recurred) on everolimus and exemestane hormone therapy. Everolimus is a chemotherapy drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen and progesterone are hormones that can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by lowering the amount of estrogen and progesterone the body makes. Giving everolimus with a different type of hormone therapy may be an effective treatment for breast cancer in patients who progressed on everolimus with exemestane.

Start: November 2014

A Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)

E1Z11 is a study to determine whether certain genetic information can predict which breast cancer patients will discontinue treatment with AIs due to the development of musculoskeletal symptoms (MSS). Women with stage 1-111 breast cancer who are prescribed the aromatase inhibitor anastrozole as treatment may join.

Start: May 2013

BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer

This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer. The PI3K inhibitor BYL719 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving the PI3K inhibitor BYL719 together with letrozole may kill more tumor cells

Start: April 2013

Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)

A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.

Start: March 2020

Evaluation of Endocrine Therapy Effects of Host Immunity in Early Stage Breast Cancer

The purpose of this research study is to learn about the effects that standard of care endocrine therapies have on the immune system's response to cancer by looking at the number and types of immune cells present and how they function in women with early stage estrogen receptor positive (ER+) breast cancer.

Start: June 2019

[18F]FES PET/CT in Endocrine Refractory Breast Cancer

In this study, positron emission tomography (PET/CT) imaging will be used to evaluate estrogen receptor (ER) activity in sites of metastatic disease using the investigational radiotracer [18F]fluoroestradiol (FES).

Start: May 2015

Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

The purpose of phase 1 is to determine safety, tolerability and pharmacokinetics (PK) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The purpose of phase 2 is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation [including a clonal estrogen receptor 1 gene (ESR1) Y537S mutation].

Start: August 2017

A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer

This is a neoadjuvant study to determine the feasibility and tolerability of 2 weeks of a very low carbohydrate ketogenic diet in combination with letrozole for patients with early stage operable ER+disease.

Start: July 2019

FDG PET/CT in Breast Cancer Bone Mets

This study will evaluate baseline uptake on a FDG PET/CT scan in patients with breast cancer that has spread to the bones. A repeat FDG PET/CT scan will be done 4 weeks after the start of new breast cancer hormone treatment and again at 12 weeks after treatment start. The baseline uptake and change in uptake after the repeat scans will be compared to clinical long term outcomes such as time to progression and overall survival. In addition the uptake will be compared to the incidence of skeletal related events that are common occurrences in patients with cancer that has spread to the bones.

Start: September 2013

COX Inhibition and Biomarkers During Neoadjuvant Chemoendocrine Therapy for ER+, HER2- Stage I-III Breast Cancer

This study is designed to assess the safety and clinical activity of tamoxifen and the COX inhibitor, aspirin, given in combination with standard AC-T chemotherapy (doxorubicin, cyclophosphamide, and paclitaxel) for the treatment of high-risk estrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)- breast cancer. If successful, the study could improve long-term outcomes for a subpopulation of women with aggressive stage I-III ER+/HER2- breast cancer.

Start: October 2019

Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anticancer therapies for their advanced/metastatic disease.

Start: June 2016