A study to investigate the safety and effectiveness of a new anti cancer treatment - AZD5363 and assess its ability to affect levels of key proteins in cancer cells prior to the surgical removal of breast cancer.
- Conditions
- primary breast cancerMedDRA version: 18.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-005019-14-GB
- Lead Sponsor
- niversity of Nottingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Provision of written informed consent
WHO performance status 0-1
Able to swallow and retain oral medication
Pre-menopausal (if surgically sterile or use acceptable contraception) or post-menopausal.
Aged 18 years or over with histological confirmation of ER positive invasive breast carcinoma
Stage 1/2/3 or Stage 4 with primary tumour in the breast amenable to biopsies
scheduled to have chemotherapy (with or without surgery). New primary breast tumours (ipsi- or contra-lateral) despite prior endocrine treatment for an earlier primary breast tumour with at least 12 months interval between cessation of endocrine therapy and Visit 1 are eligible.
Tumours large enough to provide sufficient tissue to be taken by core-cut or tru-cut biopsy.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
1Any prior treatment for breast cancer except new primary breast tumours despite prior endocrine treatment for an earlier primary breast tumour with at least 12 months interval between cessation of endocrine therapy and Visit 1.
2Known ER negative tumour.
3Female patients with histological confirmation of ER positive invasive breast carcinoma not scheduled to have chemotherapy (with or without surgery) based on tumour characteristics and local treatment protocols
4 Exposure to potent inhibitors or inducers of CYP3A4 or CYP2D6 or substrates of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John’s Wort).
5Clinically significant abnormalities of glucose metabolism as defined by any of the following:
?Diagnosis of diabetes mellitus type I or II (irrespective of management).
?Glycosylated haemoglobin (HbA1C) =8.0% at screening (64 mmol/mol) (conversion equation for HbA1C [IFCC-HbA1C (mmol/mol) = [DCCT-HbA1C (%) – 2.15] x 10.929)
?Fasting Plasma Glucose = 7.0mmol/L (126 mg/dL) at screening. Fasting is defined as no caloric intake for at least 8 hours.
6Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of study treatment.
7Spinal cord compression or brain metastases.
8As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
9Any of the following cardiac criteria:
?Mean resting corrected QT interval (QTc) >450 msec obtained from 3 consecutive ECGs.
?Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block.
?Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, a history of congenital long QT syndrome, family history of long QT syndrome or a history of unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval. Further Information regarding this is given in Appendix 8.
?Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade 2.
?Uncontrolled hypotension – SBP <90 mmHg and/or DBP <50 mmHg.
10Absolute neutrophil count <1.5 x 109/L.
11Platelet count <100 x 109/L.
12Haemoglobin <9 g/dL (<5.59 mmol/L). [Note: any blood transfusion must be >14 days prior to the determination of a haemoglobin =9 g/dL (=5.59 mmol/L)].
13Alanine aminotransferase (ALT) >2.5 times ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases.
14Elevated Alkaline phosphatase (ALP) is not exclusionary if due to the presence of bone metastasis and liver function is otherwise considered adequate in the investigator’s judgement.
15Total bil
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method