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

This study has been terminated.

Sponsor:

Information provided by:

Antisoma Research

ClinicalTrials.gov Identifier:

NCT00770354

First received: October 9, 2008

Last updated: August 7, 2009

Last verified: August 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 9, 2008

Last Updated Date

August 7, 2009

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary efficacy endpoint is overall response rate (ORR) [ Time Frame: Radiological evaluations are performed every 12 weeks up to progression ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00770354 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression-free survival (PFS) [ Time Frame: Radiological evaluations are performed every 12 weeks up to progression ] [ Designated as safety issue: No ]
Time to progression (TTP) [ Time Frame: Radiological evaluations are performed every 12 weeks up to progression ] [ Designated as safety issue: No ]
Duration of overall response and duration of stable disease [ Time Frame: Radiological evaluations are performed every 12 weeks up to progression ] [ Designated as safety issue: No ]
Clinical benefit rate (CBR) [ Time Frame: Radiological evaluations are performed every 12 weeks up to progression ] [ Designated as safety issue: No ]
Safety and tolerability of AS1402 when combined with letrozole [ Time Frame: Radiological evaluations are performed every 12 weeks up to progression ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Carcinoma

Intervention ^ICMJE

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 Name: huHMFG1
Drug: Letrozole
Daily 2.5 mg oral letrozole tablet

Other Name: Femara

Study Arm (s)

Experimental: 1
AS1402 plus letrozole

Intervention: Drug: AS1402
Active Comparator: 2
Letrozole

Intervention: Drug: Letrozole

Publications *

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. Epub 2011 Aug 30.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

110

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Russian Federation

Administrative Information

NCT Number ^ICMJE

NCT00770354

Other Study ID Numbers ^ICMJE

AS1402-C-201

Has Data Monitoring Committee

Yes

Responsible Party

Gary Acton, Antisoma

Study Sponsor ^ICMJE

Antisoma Research

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Antisoma Research

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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