Patients with locally advanced or metastatic oestrogen receptor positive (ER+ve) breast cancer who have received at least one hormonal therapy and at least one chemotherapy in the metastatic setting. MedDRA version: 18.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version:
Conditions
Interventions
Trade Name: Halaven
Product Name: HALAVEN
Product Code: NA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Eribulin
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent prior to admission to this study 2. Aged 18=over 3. Histologically confirmed ER positive 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 weren’t 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) =9g/dL • Absolute Neutrophil Count (ANC) =1.5x109/L • Platelet count (Plts) =100x109/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 ¹RECIST 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Eribulin when prescribed in alternating cycles with an Aromatase Inhibitor (AI) in patients with locally advanced or metastatic breast cancer, based on progression free survival (PFS).; Secondary Objective: • To assess the efficacy of Eribulin when prescribed in alternating cycles with an Aromatase Inhibitor (AI) in patients with locally advanced or metastatic breast cancer, based on clinical benefit rate (CBR). • To assess the safety and tolerability of eribulin when prescribed in alternating cycles with an AI in patients with locally advanced or metastatic breast cancer. ;Primary end point(s): Progression free survival (PFS), as assessed by RECIST v1.1 at 3, 6 and 9 months, defined as time from study entry to first evidence of disease progression or death due to any cause.;Timepoint(s) of evaluation of this end point: 3, 6 and 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Clinical Benefit Rate (CBR),as assessed by RECIST v1.1 at 3, 6 and 9 months, defined as duration of complete response (CR), partial response (PR) and stable disease (SD) for 6 months or longer. • Safety and tolerability as assessed by adverse events according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.03). ; Timepoint(s) of evaluation of this end point: • CBR: 3, 6 and 9 months • Safety and tolerability: from first dose of IMP to 4 weeks after completion of study treatment | — |
Countries
United Kingdom
Contacts
Public ContactHanna Nicholas
Imperial College London
Outcome results
None listed