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

August 7, 2009 updated by: Antisoma Research

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center
    • Stavropol
      • Pyatigorsk, Stavropol, Russian Federation, 357500
        • State Medical Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
AS1402 plus letrozole
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).
Other Names:
  • huHMFG1
ACTIVE_COMPARATOR: 2
Letrozole
Drug: Letrozole
Daily 2.5 mg oral letrozole tablet
Other Names:
  • Femara

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: Radiological evaluations are performed every 12 weeks up to progression
Radiological evaluations are performed every 12 weeks up to progression
Time to progression (TTP)
Time Frame: Radiological evaluations are performed every 12 weeks up to progression
Radiological evaluations are performed every 12 weeks up to progression
Duration of overall response and duration of stable disease
Time Frame: Radiological evaluations are performed every 12 weeks up to progression
Radiological evaluations are performed every 12 weeks up to progression
Clinical benefit rate (CBR)
Time Frame: Radiological evaluations are performed every 12 weeks up to progression
Radiological evaluations are performed every 12 weeks up to progression
Safety and tolerability of AS1402 when combined with letrozole
Time Frame: Radiological evaluations are performed every 12 weeks up to progression
Radiological evaluations are performed every 12 weeks up to progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antisoma Research

Investigators

  • Study Director: Gary Acton, MA MBBS MRCP, Antisoma Research
  • Principal Investigator: Nuhad K Ibrahim, MD FACP, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ANTICIPATED)

August 1, 2010

Study Completion (ANTICIPATED)

August 1, 2011

Study Registration Dates

First Submitted

October 9, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (ESTIMATE)

October 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2009

Last Update Submitted That Met QC Criteria

August 7, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS1402-C-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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