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

Phase 2

Terminated

• Conditions: Breast Carcinoma
• Interventions: Drug: AS1402; Drug: Letrozole

• Registration Number: NCT00770354
• Lead Sponsor: Antisoma Research

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 compared to letrozole alone

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-07
• Last Update Posted: 2009-08-10
• Primary Completion: 2010-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AS1402	AS1402 plus letrozole
2	Letrozole	Letrozole

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is overall response rate (ORR)	Radiological evaluations are performed every 12 weeks up to progression

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Radiological evaluations are performed every 12 weeks up to progression
Time to progression (TTP)	Radiological evaluations are performed every 12 weeks up to progression
Duration of overall response and duration of stable disease	Radiological evaluations are performed every 12 weeks up to progression
Clinical benefit rate (CBR)	Radiological evaluations are performed every 12 weeks up to progression
Safety and tolerability of AS1402 when combined with letrozole	Radiological evaluations are performed every 12 weeks up to progression

Trial Locations

Locations (2)

State Medical Institution; 🇷🇺 Pyatigorsk, Stavropol, Russian Federation

State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center; 🇷🇺 Chelyabinsk, Russian Federation