oestrogen receptor, androgen receptor positive early breast cancer MedDRA version: 19.0 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10070577 Term: Oestrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Enobosarm
Product Code: GTx-0024
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: enobosarm
CAS Number: 841205-47-8
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •16 years of age or older •Histologically confirmed ER+ve breast cancer (Allred =3) •AR+ve breast cancer (defined as =10% nuclear AR staining by immunohistochemistry)* •Any HER2 status •Tumour measuring =14mm in longest diameter by ultrasound (US) examination •Postmenopausal women as defined by one of the following criteria: o Amenorrhoea >12 months at the time of diagnosis and an intact uterus, with FSH and estradiol in the postmenopausal ranges o Prior bilateral oophorectomy o FSH and estradiol levels within the postmenopausal range (as per local practice) in women aged =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: •Inoperable breast cancer •Inflammatory tumours •Evidence of metastatic disease •Any history of invasive malignancy within 5 years of starting study treatment (other than adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ) •Evidence of bleeding diathesis •Prior endocrine therapy of chemotherapy for breast cancer •Concomitant use (defined as use within 12 weeks prior to entry) of HRT or any other oestrogen-containing medication or supplement (including vaginal oestrogens and phytoestrogens) •Previous use of oestrogen implants at ANY time •Uncontrolled abnormalities of serum potassium, sodium, calcium or magnesium levels •Evidence of uncontrolled active infection •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 •Participation in a clinical trial of an IMP in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the primary objective in this study is to see the response to enobosarm as measured by changes in Ki67 proliferation index after 14 days of treatment in ER positive, AR positive early breast cancer ;Secondary Objective: The secondary objectives in this study are: 1. Changes in pro-apoptotic marker cleaved caspase 3 after 2 weeks of treatment 2. Changes in expression by immunohistochemistry of PSA, Gross Cystic Disease Fluid Proteins (GCDFP)-24 &-15; PgR, GREB1 after 2 weeks of treatment 3. Changes in circulating steroidogenic hormones & Prostrate Specific Antigen (PSA) 4. Safety and tolerability in terms of: • Occurance of grade 3+ toxicity classified by NCI-CTCAE v4.0. • Occurrence of serious adverse events • Withdrawal from trial treatment due to toxicity • Experience of delay to scheduled surgery ;Primary end point(s): The primary outcome measure is the change in Ki67 score after 14 days of treatment from baseline (day 1) to surgery (day 14 +4);Timepoint(s) of evaluation of this end point: Samples will be taken at baseline and after 14 (+4) days of treatment (ending the day before or the day of surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Changes in pro-apoptotic marker cleaved caspase 3 after 2 weeks of treatment •Changes in expression by immunohistochemistry of PSA, Gross Cystic Disease Fluid Proteins (GCDFP)-24 &-15; PgR, GREB1 after 2 weeks of treatment •Changes in circulating steroidogenic hormones & Prostrate Specific Antigen (PSA) •Safety and tolerability in terms of: o Occurrence of grade 3+ toxicity classified by NCI-CTCAE v4.0. o Occurrence of serious adverse events o Withdrawal from trial treatment due to toxicity o Experience of delay to scheduled surgery ;Timepoint(s) of evaluation of this end point: Baseline 14 (+4) days of treatment | — |
Countries
United Kingdom
Contacts
Public ContactGreg Gibson
CRUK Liverpool Cancer Trials Unit
Outcome results
None listed