Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02681523
Recruitment Status : Terminated (Slow patient recruitment)
First Posted : February 12, 2016
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Eribulin Phase 2

Detailed 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 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
Drug: Eribulin
Other Name: Halaven




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Written informed consent prior to admission to this study
  • 2. Aged 18≥over
  • 3. Histologically confirmed ER+ve metastatic breast cancer according to local criteria
  • 4. ECOG performance status 0 - 2
  • 5. Have progressed after at least one hormonal therapy regime and at least one chemotherapy regime for advanced disease
  • 6. Patients must have had prior treatment with an anthracycline and a taxane (either sequential or in combination) unless patients were not suitable for these treatments. This treatment can be in the adjuvant setting
  • 7. Measurable sites of locally advanced and/or metastatic disease that can be accurately assessed by CT/MRI scan at baseline (RECIST v1.1)¹
  • 8. Life expectancy of ≥6 months
  • 9. Adequate organ function, as defined by:

    • Haemoglobin (Hb) ≥ 9 g/dL
    • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
    • Platelet count (Plts) ≥ 100 x 109/L
    • White Blood Cell (WBC) ≥ 3.0 x 109/L
    • Serum albumin ≤ 1.5 ULN
    • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x ULN if no demonstrable liver metastases or ≤ 5 x ULN in the presence of liver metastases.
    • ALP ≤ 5 x ULN
    • Total bilirubin ≤ 1.5 x ULN if no demonstrable liver metastases or ≤ 3 x ULN in the presence of liver metastases
    • Creatinine ≤ 1.5 x ULN or creatinine clearance >50ml/min
  • 10. Postmenopausal as defined by age >50, no menstruation for >2 years, previous oophorectomy or lab results confirming this status
  • 11. Premenopausal if has been subject to ovarian ablation/ suppression at least 3 weeks prior to commencing AI therapy

    • RECIST v1.1 updated and now considers bone metastasis with an identifiable soft tissue mass to be measurable disease. Therefore, patients with bone metastasis are eligible, provided they have evaluable disease.

Exclusion Criteria:

  • 1.Triple negative or HER2 positive cancer
  • 2. Hypersensitivity to the active substance or to any of its excipients
  • 3. History of another primary malignancy within 5 years prior to starting study treatment, except adequately treated basal or squamous cell carcinoma of the skin, carcinoma in site and the disease under study
  • 4. Evidence of uncontrolled active infection
  • 5. Severe hepatic impairment (Child-Pugh C)
  • 6. Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial
  • 7. Concurrent therapy with any other investigational agent or everolimus
  • 8. Concomitant use within 14 days prior to commencement of study treatment of any investigational agent
  • 9. Uncontrolled abnormalities of serum potassium, sodium, calcium (corrected) phosphate or magnesium levels
  • 10. Pregnant or lactating women. Effective non-hormonal contraception is mandatory for all patients of reproductive potential
  • 11. Evidence of ovarian activity
  • 12. Prior eribulin therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681523


Locations
Layout table for location information
United Kingdom
Charing Cross Hopsital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Investigators
Layout table for investigator information
Principal Investigator: Laura Kenny Consultant Medical Oncologist

Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02681523     History of Changes
Other Study ID Numbers: C/31/2014
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not currently planned in the protocol.
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases