Advanced, Oestrogen Receptor Positive Breast Cancer for whom Prior Endocrine Therapies have Failed, One of which was 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 P
Sponsors
Bioenvision
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must provide written informed consent prior to any study procedures being performed and according to local ethics committee guidelines • Female patients aged over 18 years • Patients must be post-menopausal, defined as >12 months since last menses. In patients whose last menses was =12 months before start of treatment, follicle stimulating hormone (FSH) and luteinising hormone (LH) levels must be in post-menopausal range: FSH =35 IU/L and LH >40 IU/L • Patients must have histological diagnosis of ER positive breast cancer and have relapsed or are refractory to hormone therapies, one of which must have been a new generation AI (letrozole, exemestane or anastrozole), prior to Screening • Patients must have performance status =2 ECOG scale • Patients must be suitable for hormone therapy in the investigator’s opinion • Patients with a life expectancy of >3 months • Patients with bone metastases are eligible provided that they have evaluable sites of metastases that can be followed by x-ray, MRI/CT scan • Patients must have measurable disease according to the RECIST criteria • All prior hormonal therapy must have failed (ie, either relapsed or refractory) • Patients must have haemoglobin =9.0 g/dL (after transfusion if needed) at Screening • Patients must have a white blood cell (WBC) count =3,500/mm3 at Screening • Patients must have neutrophils =1,500/mm3 at Screening • Patients must have platelets =100,000/mm3 at Screening • Patients must have creatinine =1.5 x upper limit of normal (ULN) for the testing laboratory, or a creatinine clearance =60 mL/minute at Screening • Patients must have serum bilirubin =1.5 mg/dL at Screening • 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) no 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: The primary objective is to determine with a specified level of precision the clinical benefit rate (CBR) of up to 6 months treatment with trilostane 720 mg and concomitant hydrocortisone 20 mg in post menopausal women with advanced, ER positive breast cancer for whom prior endocrine therapies have failed, one of which was an AI. ; Secondary Objective: Secondary Objectives: • To determine objective tumour response • To determine toxicity • To determine time to PD • To determine duration of response • To determine performance status ; Primary end point(s): CBR is defined as the proportion of patients with any of the following assessments using the Response Evaluation Criteria in Solid Tumours (RECIST) system (see Appendix II) at both the 3-month and 6 month visits: • CR • PR • SD CR and PR must be subsequently confirmed 4 weeks later. | — |
Countries
United Kingdom
Outcome results
None listed