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A Prospective,Open-label Study of Anastrozole in Post-menopausal Women With Hormone Sensitive Advanced Breast Cancer

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.
ClinicalTrials.gov Identifier: NCT00544986
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):

Brief Summary:
The overall objective of the clinical study is to assess the tolerability and clinical efficacy of anastrozole in post-menopausal women with hormone sensitive advanced breast cancer in India.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Anastrozole Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective,Open-label Study of Anastrozole in Post-menopausal Women With Hormone Sensitive Advanced Breast Cancer
Study Start Date : June 2005
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 1. Tolerability(safety) 2.Efficacy (a) Time to tumor progression TTP (b) Objective Response (OR) Rate (c) Symptom Evaluation

Secondary Outcome Measures :
  1. Efficacy (a) Time to treatment failure TTF (b)Duration of Response DOR (c) Duration of Clinical Benefit

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Patients must be adult (age ≥ 18 years age) post-menopausal* women
  2. Patients must be diagnosed with advanced breast cancer (histologically or cytological confirmation required) i.e. TNM stage III or IV disease (locally advanced or metastatic breast cancer) or locoregional recurrent disease, not suitable for treatment by local surgery or radiation therapy
  3. Measurable or evaluable disease
  4. Patients with ER/PR positive tumour or ER/PR unknown status
  5. Patients must be suitable for endocrine treatment with anastrozole
  6. Prior adjuvant chemotherapy or endocrine therapy for early breast cancer is allowed, provided such treatment was completed at least twelve months prior to study enrollment
  7. Performance status 0-2 (As per WHO Classification)
  8. Concurrent use of bisphosphonates is permitted.
  9. Patients must give their written informed consent for participation in the study

Exclusion Criteria:

  1. Patients with tumors known to be estrogen and progesterone receptor-negative.
  2. Estrogen hormone replacement therapy, concurrently or within 6 weeks before randomization
  3. Extensive visceral involvement (significant hepatic involvement, brain metastasis or pulmonary involvement > 50% of the lungs); serum liver enzymes SGOT and SGPT should be no greater than five times the upper limit of the reference range
  4. Patients received bone marrow transplantation before randomization
  5. Any concurrent medical illness (uncontrolled cardiac disease or diabetes mellitus) or laboratory abnormalities that would compromise safety or prevent interpretation of results
  6. An estimated survival of less than 3 months from the start of Study drug treatment based on clinical judgment.
  7. Any systemic investigational drug within the thirty days of enrollment into study

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): NCT00544986

Sponsors and Collaborators
Principal Investigator: Poonamalle P Bapsy, MD Kidwai Memorial Institute of Oncology, Bangalore, INDIA

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00544986     History of Changes
Other Study ID Numbers: D5391L00001
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by AstraZeneca:
breast cancer
post menopausal women
Post menopausal women with hormone sensitive advanced breast cancer

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