A Phase II, Non-randomised, Study of Modrenal (Trilostane) in Pre-menopausal Women with Oestrogen Receptor Positive Breast Cancer who have Relapsed or are Refractory to Hormone Therapies of Tamoxifen, Goserelin and an Aromatase Inhibitor

Phase 1

• Conditions: Oestrogen Receptor Positive Breast Cancer who have Relapsed or are Refractory to Hormone Therapies of Tamoxifen, Goserelin and an Aromatase Inhibitor; MedDRA version: 7.0Level: LLTClassification code 10057654

• Registration Number: EUCTR2004-004028-11-GB
• Lead Sponsor: Bioenvision Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-23
• Study Completion: 2007-02-21
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 44

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified