ALERT: A Phase II Study of Alternating Eribulin & Hormonal Therapy in

Status Terminated

Clinical Trial Summary

A single centre, single arm phase II study of alternating eribulin and hormonal therapy in 12 patients with locally advanced or metastatic breast cancer who have received at least one hormonal therapy and at least one chemotherapy in the metastatic setting.

Clinical Trial Description

12 patients with locally advanced or metastatic breast cancer who have received at least one hormonal therapy and at least one chemotherapy in the metastatic setting will be enrolled to receive treatment. Once patients are consented and have completed on study screening, eribulin and Aromatase Inhibitor (AI) treatment will be alternated for up to 9 months, until disease progression or unacceptable toxicities, whichever is sooner. Patients will then attend a safety follow-up visit 4 weeks after completing treatment. Eribulin (Halaven®) is a non-taxane microtubule dynamics inhibitor. Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into non-productive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage. Eribulin is licenced for the treatment of patients with locally advanced or metastatic breast cancer who have previously received at least one chemotherapeutic regimen for the treatment of advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. The aim of this study is to alternate eribulin and aromatase inhibitors, examining whether there may be breakthrough relapse during the AI therapy or on the other hand we can extend the duration that eribulin may be used for. Importantly, blood based biomarkers, the tumour derived fraction of circulating free DNA (cfDNA) termed circulating tumor DNA (ctDNA), and circulating tumour cells will be measured. A major aim of this study is to test whether biomarkers fluctuate between chemotherapy and AI treatment in the setting of advanced breast cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02681523
Study type	Interventional
Source	Imperial College London
Contact
Status	Terminated
Phase	Phase 2
Start date	October 28, 2015
Completion date	July 24, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04681911` - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer	Phase 2
Completed	`NCT04890327` - Web-based Family History Tool	N/A
Terminated	`NCT04066790` - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer	Phase 2
Completed	`NCT03591848` - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility	N/A
Recruiting	`NCT03954197` - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients	N/A
Terminated	`NCT02202746` - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer	Phase 2
Active, not recruiting	`NCT01472094` - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Recruiting	`NCT06057636` - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study	N/A
Recruiting	`NCT06049446` - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting	`NCT05560334` - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations	Phase 2
Active, not recruiting	`NCT05501769` - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer	Phase 1
Recruiting	`NCT04631835` - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer	Phase 1
Completed	`NCT04307407` - Exercise in Breast Cancer Survivors	N/A
Recruiting	`NCT03544762` - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation	Phase 3
Terminated	`NCT02482389` - Study of Preoperative Boost Radiotherapy	N/A
Enrolling by invitation	`NCT00068003` - Harvesting Cells for Experimental Cancer Treatments
Completed	`NCT00226967` - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06019325` - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy	N/A
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

ALERT: A Phase II Study of Alternating Eribulin and Hormonal Therapy in Pre-treated ER+ve Breast Cancer. — ALERT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms