NCT00770354

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2008

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 10, 2009

Status Verified

August 1, 2009

Enrollment Period

1.9 years

First QC Date

October 9, 2008

Last Update Submit

August 7, 2009

Conditions

Breast Carcinoma

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy endpoint is overall response rate (ORR)

    Radiological evaluations are performed every 12 weeks up to progression

Secondary Outcomes (5)

  • 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

Study Arms (2)

1

EXPERIMENTAL

AS1402 plus letrozole

Drug: AS1402

2

ACTIVE COMPARATOR

Letrozole

Drug: Letrozole

Interventions

AS1402DRUG

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).

Also known as: huHMFG1
1
LetrozoleDRUG

Daily 2.5 mg oral letrozole tablet

Also known as: Femara
2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

State Medical Institution

Pyatigorsk, Stavropol Kray, 357500, Russia

Location

State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center

Chelyabinsk, 454087, Russia

Location

Related Publications (2)

  • Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.

    PMID: 40443562DERIVED

  • Ibrahim NK, Yariz KO, Bondarenko I, Manikhas A, Semiglazov V, Alyasova A, Komisarenko V, Shparyk Y, Murray JL, Jones D, Senderovich S, Chau A, Erlandsson F, Acton G, Pegram M. Randomized phase II trial of letrozole plus anti-MUC1 antibody AS1402 in hormone receptor-positive locally advanced or metastatic breast cancer. Clin Cancer Res. 2011 Nov 1;17(21):6822-30. doi: 10.1158/1078-0432.CCR-11-1151. Epub 2011 Aug 30.

    PMID: 21878535DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

epitumomabLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gary Acton, MA MBBS MRCP

    Antisoma Research

    STUDY DIRECTOR

  • Nuhad K Ibrahim, MD FACP

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2011

Last Updated

August 10, 2009

Record last verified: 2009-08

Locations

RU(2)