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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Carcinoma
Female
Breast Carcinoma
Trial Information
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
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or metastatic breast
cancer not amenable to curative therapy
- Measurable disease according to the RECIST criteria
- Documented estrogen receptor-positive and/or progesterone receptor-positive tumour
- Postmenopausal women
Exclusion Criteria:
- Prior chemotherapy and/or endocrine therapy for advanced breast disease
- Relapse within 12 months after treatment discontinuation of an aromatase inhibitor in
the adjuvant setting
- Unknown hormonal receptor status
- Known HER2/neu-positivity
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary efficacy endpoint is overall response rate (ORR)
Outcome Time Frame:
Radiological evaluations are performed every 12 weeks up to progression
Safety Issue:
No
Principal Investigator
Gary Acton, MA MBBS MRCP
Investigator Role:
Study Director
Investigator Affiliation:
Antisoma Research
Authority:
United States: Food and Drug Administration
Study ID:
AS1402-C-201
NCT ID:
NCT00770354
Start Date:
September 2008
Completion Date:
August 2011
Related Keywords:
- Breast Carcinoma
- Breast cancer
- Breast Neoplasms
- Carcinoma
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