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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00770354
• Other study ID #: AS1402-C-201
• Status: Terminated
• Phase: Phase 2
• First received: October 9, 2008
• Last updated: August 7, 2009
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: August 2009
• Source: Antisoma Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Drug:
• AS1402
A complete treatment cycle spans 28 days. Patients randomised to AS1402 will receive a 1-hour infusion of 9 mg/kg on day 1, 8, 15 and 22 of each cycle. Patients will receive letrozole (2.5 mg daily tablet).
• Letrozole
Daily 2.5 mg oral letrozole tablet

Locations

Country	Name	City	State
Russian Federation	State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center	Chelyabinsk
Russian Federation	State Medical Institution	Pyatigorsk	Stavropol

Sponsors (1)

Lead Sponsor	Collaborator
Antisoma Research

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is overall response rate (ORR)		Radiological evaluations are performed every 12 weeks up to progression	No
Secondary	Progression-free survival (PFS)		Radiological evaluations are performed every 12 weeks up to progression	No
Secondary	Time to progression (TTP)		Radiological evaluations are performed every 12 weeks up to progression	No
Secondary	Duration of overall response and duration of stable disease		Radiological evaluations are performed every 12 weeks up to progression	No
Secondary	Clinical benefit rate (CBR)		Radiological evaluations are performed every 12 weeks up to progression	No
Secondary	Safety and tolerability of AS1402 when combined with letrozole		Radiological evaluations are performed every 12 weeks up to progression	Yes