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

NCT00770354 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2009-08-10

No results posted yet for this study

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

Conditions

  • Breast Carcinoma

Interventions

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).

DRUG

Letrozole

Daily 2.5 mg oral letrozole tablet

Sponsors & Collaborators

  • Antisoma Research

    lead INDUSTRY

Principal Investigators

  • Gary Acton, MA MBBS MRCP · Antisoma Research

  • Nuhad K Ibrahim, MD FACP · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-08-31
Completion
2011-08-31

Countries

  • Russia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00770354 on ClinicalTrials.gov