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

Antisoma Research

Status and phase: Terminated; Phase 2

Conditions: Breast Carcinoma

Treatments: Drug: Letrozole; Drug: AS1402

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770354

AS1402-C-201

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

1

Experimental group

Description:

AS1402 plus letrozole

Treatment:

Drug: AS1402

2

Active Comparator group

Description:

Letrozole

Treatment:

Drug: Letrozole