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

Primary Purpose

Breast Carcinoma

Status

Terminated

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

AS1402

Letrozole

About this trial

This is an interventional treatment trial for Breast Carcinoma focused on measuring Breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

State Medical Institution
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

AS1402 plus letrozole

Letrozole

Outcomes

Primary Outcome Measures

The primary efficacy endpoint is overall response rate (ORR)

Secondary Outcome Measures

Progression-free survival (PFS)

Time to progression (TTP)

Duration of overall response and duration of stable disease

Clinical benefit rate (CBR)

Safety and tolerability of AS1402 when combined with letrozole

Full Information

NCT ID

NCT00770354

First Posted

October 9, 2008

Last Updated

August 7, 2009

Sponsor

Antisoma Research

1. Study Identification

Unique Protocol Identification Number

NCT00770354

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Terminated

Study Start Date

September 2008 (undefined)

Primary Completion Date

August 2010 (Anticipated)

Study Completion Date

August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Antisoma Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Carcinoma

Keywords

Breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AS1402 plus letrozole

Arm Title

Arm Type

Active Comparator

Arm Description

Letrozole

Intervention Type

Drug

Intervention Name(s)

AS1402

Other Intervention Name(s)

huHMFG1

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Letrozole

Other Intervention Name(s)

Femara

Intervention Description

Daily 2.5 mg oral letrozole tablet

Primary Outcome Measure Information:

Title

The primary efficacy endpoint is overall response rate (ORR)

Time Frame