A Phase II, Randomised, Open-Label, Multicentre Study of AS1402 in Combination with Letrozole as First Line Treatment in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer.
- Conditions
- ocally Advanced or Metastatic Breast CancerMedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancer
- Registration Number
- EUCTR2008-001806-17-PL
- Lead Sponsor
- Antisoma Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 110
For enrolment into the study, patients must satisfy the following criteria:
1. Willing and able to provide written informed consent and in the opinion of the
Investigator be able to comply with the study assessments and follow-up
2. Histologically or cytologically confirmed locally advanced or metastatic breast
cancer not amenable to curative therapy
3. Measurable disease according to the RECIST criteria
4. Estrogen receptor-positive and/or progesterone receptor-positive tumour
5. Postmenopausal women defined as
a. Natural menopause with last menses more than 1 year ago, or
b. Radiotherapy-induced menopause with last menses more than 1 year
ago, or
c. Chemotherapy-induced menopause with last menses more than 1 year
ago AND serum follicle-stimulating hormone and luteinizing hormone
and estradiol levels clearly in the postmenopausal range, or
d. Bilateral oophorectomy
6. Performance status 0 or 1
7. Granulocyte count > 1.0 x 10^9/l
8. Platelet count > 100 x 10^9/l
9. Bilirubin < 2 times the upper limit of normal (ULN)
10. AST and/or ALT < 5 times ULN
11. Creatinine Clearance > 30 ml/min.
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
Patients with any of the following will be excluded from the study:
1. Prior chemotherapy and/or endocrine therapy for advanced breast disease
2. Relapse within 12 months after treatment discontinuation of an aromatase
inhibitor in the adjuvant setting
3. Unknown hormonal receptor status
4. Known HER2/neu-positivity defined by either
a. 3+ by immunohistochemistry, or
b. HER2-positive by fluorescent in situ hybridization
5. Pregnant or nursing
6. Known HIV positivity
7. Ongoing or active infection (grade >1)
8. Psychiatric illness or social situation that would preclude study compliance
9. Other uncontrolled illness
10. History of other malignancy within the last 5 years, not including curatively treated
carcinoma in situ of the cervix or non-melanoma skin cancer.
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