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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Drug: AS1402
* Drug: Letrozole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AS1402 plus letrozole | Drug: AS1402<br>* 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).<br>* Other names: huHMFG1;|
| Active Comparator: 2<br>Letrozole | Drug: Letrozole<br>* Daily 2.5 mg oral letrozole tablet<br>* Other names: Femara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint is overall response rate (ORR) |  | Radiological evaluations are performed every 12 weeks up to progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer