Oestrogen Receptor Positive Breast Cancer who have Relapsed or are Refractory to Hormone Therapies of Tamoxifen, Goserelin and an Aromatase Inhibitor MedDRA version: 7.0 Level: LLT Classification code 10057654
Conditions
Interventions
Trade Name: Modrenal 120mg Capsules
Product Name: Modrenal Capsules
Product Code: Trilostane
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Trilostane
CAS Number: 13647-35-3
Current Sponsor c
Sponsors
Bioenvision Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients must provide written informed consent prior to any study procedures being performed and according to local ethics committee guidelines 2) Female patients aged over 18 years 3) Patients must be pre-menopausal, defined as last menstrual period within 1 year of inclusion, or with oestrogen and follicle stimulating hormone (FSH)/luteinising hormone (LH) levels compatible with ovarian function, particularly if the patient has had a hysterectomy; patient must be on effective non-hormonal contraception 4) Patients must have a histological diagnosis of oestrogen receptor positive breast cancer and have relapsed or are refractory to hormone therapies, which must have included tamoxifen, goserelin and an aromatase inhibitor (AI) prior to Screening 5) Patients must have performance status =2 ECOG scale 6) Patients must be suitable for hormone therapy in the investigator’s opinion 7) Patients must have measurable disease according to the RECIST criteria 8) Patients must have a life expectancy of >3 months 9) Patients with bone metastases are eligible provided that they have evaluable sites of metastases that can be followed by x-ray, MRI/CT scan. 10) Prior tamoxifen, goserelin and an aromatase inhibitor therapies must have failed (i.e. either relapsed or refractory) 11) Patients must have haemoglobin =9.0 g/dL (after transfusion or Erythropoietin therapy if needed) at Screening 12) Patients must have a white blood cell (WBC) count =3,500/mm3 at Screening 13) Patients must have neutrophils =1,500/mm3 at Screening 14) Patients must have platelets =100,000/mm3 at Screening 15) Patients must have a creatinine =1.5 x upper limit of normal (ULN) for the testing laboratory, or a creatinine clearance =60 mL/minute at Screening 16) Patients must have serum bilirubin =1.5 mg/dL at Screening 17) Patients must have aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) =2 x ULN, or if liver metastases by ultrasound or magnetic resonance imaging (MRI) scan =5 x ULN at Screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patients with inflammatory breast cancer 2) Patients with concurrent medical or psychiatric problems, unrelated to breast cancer, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy 3) Patients who are hypocortisolaemic 4) Patients who have received treatment with another investigational therapy including hormonal therapy within 30 days or five half-lives (whichever is longer) prior to entry into the study 5) Patients who are presently receiving or expect to require concurrent chemotherapy, immunotherapy, radiotherapy or chronic corticosteroid therapy. Patients who have received prior adjuvant chemotherapy will be eligible, provided the chemotherapy was administered prior to hormonal therapy and its use was stopped at least 6 months prior to study enrolment. 6) Any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study 7) Patients with brain metastases 8) Patients with severe concurrent illness 9) Patients who previously participated in the study 10) Patients with known adrenal insufficiency 11) Patients who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the clinical benefit rate (CBR) defined as disease response or stabilisation [RECIST criteria] of up to 6 months treatment with trilostane 720 mg and concomitant hydrocortisone 20 mg in pre-menopausal women with hormone receptor positive breast cancer who have relapsed or are refractory to hormone therapies including tamoxifen, Goserelin and an AI. ;Secondary Objective: Secondary Objectives: -To determine objective tumour response -To determine toxicity -To determine time to progressive disease -To determine duration of response -To determine performance status;Primary end point(s): The proportion of patients with a clinical benefit (CBR) is defined as the proportion of patients with any of the following assessments using the Response Evaluation Criteria in Solid Tumours (RECIST) system at both the 3-month and 6 month visits: - Complete response (CR)-Disappearance of all target lesions - Partial Response (PR)-At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD - Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started CR and PR must be subsequently confirmed 4 weeks later. Secondary Objectives: Objective tumour response defined as the proportion of patients with an overall CR or PR at 3 or 6 months using the RECIST system; incidence and severity of toxicity [as assessed by the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0]; time to PD; duration of response from date of first response to date of PD; performance status, using Eastern Cooperative Oncology Group (ECOG) scale. | — |
Countries
United Kingdom
Outcome results
None listed