ALERT: A Phase II Study of Alternating Eribulin and Hormonal Therapy in Pre-treated ER+ve Breast Cancer. (ALERT)
|ClinicalTrials.gov Identifier: NCT02681523|
Recruitment Status : Terminated (Slow patient recruitment)
First Posted : February 12, 2016
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Eribulin||Phase 2|
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 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 cfDNA (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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ALERT: A Phase II Study of Alternating Eribulin and Hormonal Therapy in Pre-treated ER+ve Breast Cancer.|
|Actual Study Start Date :||October 28, 2015|
|Actual Primary Completion Date :||July 24, 2018|
|Actual Study Completion Date :||July 24, 2018|
Experimental: Single arm study
3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This will then be followed by 9 weeks of AI treatment, to be followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients will remain on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever is sooner.
Other Name: Halaven
- Progression free survival as assessed by RECIST v1.1 [ Time Frame: up to 9 months ]Progression free survival to be defined as time from study entry to first evidence of disease progression or death due to any cause, as assessed by RECIST v1.0.
- Clinical benefit rate as assessed by RECIST v1.1 [ Time Frame: To be assessed at 3, 6 and 9 months. ]Clinical benefit rate to be defined as duration of complete response, partial response and stable disease, as assessed by RECIST v1.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681523
|Charing Cross Hopsital|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Laura Kenny||Consultant Medical Oncologist|