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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00770354

Enrollment

110

Registered

2008-10-10

Start date

2008-09-30

Completion date

2011-08-31

Last updated

2009-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

Keywords

Breast cancer

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

Interventions

DRUGAS1402

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).

DRUGLetrozole

Daily 2.5 mg oral letrozole tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026