A clinical trial to look at the safety and possible benefit, of alternating the drug eribulin with an Aromatase Inhibitor, in patients with pre-treated oestrogen receptor positive (ER+ve) breast cancer.
- Conditions
- 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: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-004112-11-GB
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).;<br> 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).<br> • 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.<br><br> ;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 Outcome Measures
Name Time Method <br> Secondary end point(s): • Clinical Benefit Rate (CBR),as assessed by RECIST v1.1 at 3, 6 and 9 months,<br> defined as duration of complete response (CR), partial response (PR) and stable<br> disease (SD) for 6 months or longer.<br> • Safety and tolerability as assessed by adverse events according to the Common<br> Terminology Criteria for Adverse Events (NCI-CTCAE v 4.03).<br> ;<br> Timepoint(s) of evaluation of this end point: • CBR: 3, 6 and 9 months<br> • Safety and tolerability: from first dose of IMP to 4 weeks after completion of<br> study treatment<br>