Status:

TERMINATED

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

Lead Sponsor:

Antisoma Research

Conditions:

Breast Carcinoma

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2011

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT00770354

Start Date

September 1 2008

End Date

August 1 2011

Last Update

August 10 2009

Active Locations (2)

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Page 1 of 1 (2 locations)

1

State Medical Institution

Pyatigorsk, Stavropol Kray, Russia, 357500

2

State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center

Chelyabinsk, Russia, 454087