Overview

Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer

Status:
Terminated
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
Female
Summary
The aim of this study is to compare the overall tumour response rate per RECIST in postmenopausal women with metastatic or locally advanced breast cancer receiving AS1402 in combination with letrozole compared to letrozole alone
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Antisoma Research
Treatments:
Letrozole
Criteria
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