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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
  Purpose

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


Condition Intervention Phase
Breast Carcinoma
 Drug: AS1402
Drug: Letrozole
 Phase 2

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

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Antisoma Research:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: September 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: huHMFG1
Active Comparator: 2
Letrozole
 Drug: Letrozole
Daily 2.5 mg oral letrozole tablet
Other Name: Femara

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770354

Locations
Russian Federation
State Medical Institution
Pyatigorsk, Stavropol, Russian Federation, 357500
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center
Chelyabinsk, Russian Federation, 454087
Sponsors and Collaborators
Antisoma Research
Investigators
Study Director: Gary Acton, MA MBBS MRCP Antisoma Research
Principal Investigator: Nuhad K Ibrahim, MD FACP M.D. Anderson Cancer Center
  More Information

No publications provided by Antisoma Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gary Acton, Antisoma
ClinicalTrials.gov Identifier: NCT00770354     History of Changes
Other Study ID Numbers: AS1402-C-201
Study First Received: October 9, 2008
Last Updated: August 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Antisoma Research:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013