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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770354
First Posted: October 10, 2008
Last Update Posted: August 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Antisoma Research
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 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 ]
  • Duration of overall response and duration of stable disease [ Time Frame: 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 ]
  • Safety and tolerability of AS1402 when combined with letrozole [ Time Frame: Radiological evaluations are performed every 12 weeks up to progression ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 9, 2008
First Posted: October 10, 2008
Last Update Posted: August 10, 2009
Last Verified: August 2009

Keywords provided by Antisoma Research:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs


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